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KOMBIGLYZE
Overview
What is KOMBIGLYZE?
KOMBIGLYZE XR (saxagliptin and metformin HCl extended-release) tablets contain two oral antihyperglycemic medications used in the management of type 2 diabetes: saxagliptin and metformin hydrochloride.
What does KOMBIGLYZE look like?
What are the available doses of KOMBIGLYZE?
Tablets:
What should I talk to my health care provider before I take KOMBIGLYZE?
How should I use KOMBIGLYZE?
KOMBIGLYZE XR is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus when treatment with both saxagliptin and metformin is appropriate [
].
The dosage of KOMBIGLYZE XR should be individualized on the basis of the patient’s current regimen, effectiveness, and tolerability. KOMBIGLYZE XR should generally be administered once daily with the evening meal, with gradual dose titration to reduce the gastrointestinal side effects associated with metformin. The following dosage forms are available:
The recommended starting dose of KOMBIGLYZE XR in patients who need 5 mg of saxagliptin and who are not currently treated with metformin is 5 mg saxagliptin/500 mg metformin extended-release once daily with gradual dose escalation to reduce the gastrointestinal side effects due to metformin.
In patients treated with metformin, the dosage of KOMBIGLYZE XR should provide metformin at the dose already being taken, or the nearest therapeutically appropriate dose. Following a switch from metformin immediate-release to metformin extended-release, glycemic control should be closely monitored and dosage adjustments made accordingly.
Patients who need 2.5 mg saxagliptin in combination with metformin extended-release may be treated with KOMBIGLYZE XR 2.5 mg/1000 mg. Patients who need 2.5 mg saxagliptin who are either metformin naive or who require a dose of metformin higher than 1000 mg should use the individual components.
The maximum daily recommended dosage is 5 mg for saxagliptin and 2000 mg for metformin extended-release.
No studies have been performed specifically examining the safety and efficacy of KOMBIGLYZE XR in patients previously treated with other antihyperglycemic medications and switched to KOMBIGLYZE XR. Any change in therapy of type 2 diabetes should be undertaken with care and appropriate monitoring as changes in glycemic control can occur.
Inform patients that KOMBIGLYZE XR tablets must be swallowed whole and never crushed, cut, or chewed. Occasionally, the inactive ingredients of KOMBIGLYZE XR will be eliminated in the feces as a soft, hydrated mass that may resemble the original tablet.
What interacts with KOMBIGLYZE?
Sorry No Records found
What are the warnings of KOMBIGLYZE?
Sorry No Records found
What are the precautions of KOMBIGLYZE?
Sorry No Records found
What are the side effects of KOMBIGLYZE?
Sorry No records found
What should I look out for while using KOMBIGLYZE?
KOMBIGLYZE XR is contraindicated in patients with:
What might happen if I take too much KOMBIGLYZE?
How should I store and handle KOMBIGLYZE?
Store Vizamyl at 2° to 30°C (36° to 86°F). The product does not contain a preservative. Store Vizamyl within radiation shielding. Do not use Vizamyl after the expiry date and time stated on the label.Omeprazole delayed-release capsules, USP 10 mg are off-white to pale yellow, elliptical to spherical pellets filled in size ‘3’ hard gelatin capsules with opaque lavender coloured cap and opaque yellow coloured body, imprinted on cap ‘OMEPRAZOLE’ 10 mg and on body ‘R157’ with black ink. The capsules are supplied in bottles of 30, 100, 1000 and unit-dose packages of 100 (10 x 10). Bottles of 30 NDC 55111-157-30 Bottles of 100 NDC 55111-157-01 Bottles of 1000 NDC 55111-157-10 Unit-dose packages of 100 (10 x 10) NDC 55111-157-78 Omeprazole delayed-release capsules, USP 20 mg are off-white to pale yellow, elliptical to spherical pellets filled in size ‘2’ hard gelatin capsules with opaque lavender coloured cap and opaque iron grey coloured body, imprinted on cap ‘OMEPRAZOLE’ 20 mgand on body ‘R158’ with black ink. The capsules are supplied in bottles of 30, 90, 100, 1000 and unit-dose packages of 100 (10 x 10). Bottles of 30 NDC 55111-158-30 NDC 55111-158-34 Bottles of 90 NDC 55111-158-90 Bottles of 100 NDC 55111-158-01 Bottles of 1000 NDC 55111-158-10 Unit-dose packages of 100 (10 x 10) NDC 55111-158-78 Omeprazole delayed-release capsules, USP 40 mg are off-white to pale yellow, elliptical to spherical pellets filled in size ‘Oel’ hard gelatin capsules with opaque yellow coloured cap and opaque lavender coloured body, imprinted on cap ‘OMEPRAZOLE’ 40 mg and on body ‘R159’ with black ink. The capsules are supplied in bottles of 30, 100, 500 and unit-dose packages of 100 (10 x 10). Bottles of 30 NDC 55111-159-30 Bottles of 100 NDC 55111-159-01 Bottles of 500 NDC 55111-159-05 Unit-dose packages of 100 (10 x 10) NDC 55111-159-78 StorageStore omeprazole delayed-release capsules in a tight container protected from light and moisture. Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].Omeprazole delayed-release capsules, USP 10 mg are off-white to pale yellow, elliptical to spherical pellets filled in size ‘3’ hard gelatin capsules with opaque lavender coloured cap and opaque yellow coloured body, imprinted on cap ‘OMEPRAZOLE’ 10 mg and on body ‘R157’ with black ink. The capsules are supplied in bottles of 30, 100, 1000 and unit-dose packages of 100 (10 x 10). Bottles of 30 NDC 55111-157-30 Bottles of 100 NDC 55111-157-01 Bottles of 1000 NDC 55111-157-10 Unit-dose packages of 100 (10 x 10) NDC 55111-157-78 Omeprazole delayed-release capsules, USP 20 mg are off-white to pale yellow, elliptical to spherical pellets filled in size ‘2’ hard gelatin capsules with opaque lavender coloured cap and opaque iron grey coloured body, imprinted on cap ‘OMEPRAZOLE’ 20 mgand on body ‘R158’ with black ink. The capsules are supplied in bottles of 30, 90, 100, 1000 and unit-dose packages of 100 (10 x 10). Bottles of 30 NDC 55111-158-30 NDC 55111-158-34 Bottles of 90 NDC 55111-158-90 Bottles of 100 NDC 55111-158-01 Bottles of 1000 NDC 55111-158-10 Unit-dose packages of 100 (10 x 10) NDC 55111-158-78 Omeprazole delayed-release capsules, USP 40 mg are off-white to pale yellow, elliptical to spherical pellets filled in size ‘Oel’ hard gelatin capsules with opaque yellow coloured cap and opaque lavender coloured body, imprinted on cap ‘OMEPRAZOLE’ 40 mg and on body ‘R159’ with black ink. The capsules are supplied in bottles of 30, 100, 500 and unit-dose packages of 100 (10 x 10). Bottles of 30 NDC 55111-159-30 Bottles of 100 NDC 55111-159-01 Bottles of 500 NDC 55111-159-05 Unit-dose packages of 100 (10 x 10) NDC 55111-159-78 StorageStore omeprazole delayed-release capsules in a tight container protected from light and moisture. Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].Omeprazole delayed-release capsules, USP 10 mg are off-white to pale yellow, elliptical to spherical pellets filled in size ‘3’ hard gelatin capsules with opaque lavender coloured cap and opaque yellow coloured body, imprinted on cap ‘OMEPRAZOLE’ 10 mg and on body ‘R157’ with black ink. The capsules are supplied in bottles of 30, 100, 1000 and unit-dose packages of 100 (10 x 10). Bottles of 30 NDC 55111-157-30 Bottles of 100 NDC 55111-157-01 Bottles of 1000 NDC 55111-157-10 Unit-dose packages of 100 (10 x 10) NDC 55111-157-78 Omeprazole delayed-release capsules, USP 20 mg are off-white to pale yellow, elliptical to spherical pellets filled in size ‘2’ hard gelatin capsules with opaque lavender coloured cap and opaque iron grey coloured body, imprinted on cap ‘OMEPRAZOLE’ 20 mgand on body ‘R158’ with black ink. The capsules are supplied in bottles of 30, 90, 100, 1000 and unit-dose packages of 100 (10 x 10). Bottles of 30 NDC 55111-158-30 NDC 55111-158-34 Bottles of 90 NDC 55111-158-90 Bottles of 100 NDC 55111-158-01 Bottles of 1000 NDC 55111-158-10 Unit-dose packages of 100 (10 x 10) NDC 55111-158-78 Omeprazole delayed-release capsules, USP 40 mg are off-white to pale yellow, elliptical to spherical pellets filled in size ‘Oel’ hard gelatin capsules with opaque yellow coloured cap and opaque lavender coloured body, imprinted on cap ‘OMEPRAZOLE’ 40 mg and on body ‘R159’ with black ink. The capsules are supplied in bottles of 30, 100, 500 and unit-dose packages of 100 (10 x 10). Bottles of 30 NDC 55111-159-30 Bottles of 100 NDC 55111-159-01 Bottles of 500 NDC 55111-159-05 Unit-dose packages of 100 (10 x 10) NDC 55111-159-78 StorageStore omeprazole delayed-release capsules in a tight container protected from light and moisture. Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].Omeprazole delayed-release capsules, USP 10 mg are off-white to pale yellow, elliptical to spherical pellets filled in size ‘3’ hard gelatin capsules with opaque lavender coloured cap and opaque yellow coloured body, imprinted on cap ‘OMEPRAZOLE’ 10 mg and on body ‘R157’ with black ink. The capsules are supplied in bottles of 30, 100, 1000 and unit-dose packages of 100 (10 x 10). Bottles of 30 NDC 55111-157-30 Bottles of 100 NDC 55111-157-01 Bottles of 1000 NDC 55111-157-10 Unit-dose packages of 100 (10 x 10) NDC 55111-157-78 Omeprazole delayed-release capsules, USP 20 mg are off-white to pale yellow, elliptical to spherical pellets filled in size ‘2’ hard gelatin capsules with opaque lavender coloured cap and opaque iron grey coloured body, imprinted on cap ‘OMEPRAZOLE’ 20 mgand on body ‘R158’ with black ink. The capsules are supplied in bottles of 30, 90, 100, 1000 and unit-dose packages of 100 (10 x 10). Bottles of 30 NDC 55111-158-30 NDC 55111-158-34 Bottles of 90 NDC 55111-158-90 Bottles of 100 NDC 55111-158-01 Bottles of 1000 NDC 55111-158-10 Unit-dose packages of 100 (10 x 10) NDC 55111-158-78 Omeprazole delayed-release capsules, USP 40 mg are off-white to pale yellow, elliptical to spherical pellets filled in size ‘Oel’ hard gelatin capsules with opaque yellow coloured cap and opaque lavender coloured body, imprinted on cap ‘OMEPRAZOLE’ 40 mg and on body ‘R159’ with black ink. The capsules are supplied in bottles of 30, 100, 500 and unit-dose packages of 100 (10 x 10). Bottles of 30 NDC 55111-159-30 Bottles of 100 NDC 55111-159-01 Bottles of 500 NDC 55111-159-05 Unit-dose packages of 100 (10 x 10) NDC 55111-159-78 StorageStore omeprazole delayed-release capsules in a tight container protected from light and moisture. Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].Omeprazole delayed-release capsules, USP 10 mg are off-white to pale yellow, elliptical to spherical pellets filled in size ‘3’ hard gelatin capsules with opaque lavender coloured cap and opaque yellow coloured body, imprinted on cap ‘OMEPRAZOLE’ 10 mg and on body ‘R157’ with black ink. The capsules are supplied in bottles of 30, 100, 1000 and unit-dose packages of 100 (10 x 10). Bottles of 30 NDC 55111-157-30 Bottles of 100 NDC 55111-157-01 Bottles of 1000 NDC 55111-157-10 Unit-dose packages of 100 (10 x 10) NDC 55111-157-78 Omeprazole delayed-release capsules, USP 20 mg are off-white to pale yellow, elliptical to spherical pellets filled in size ‘2’ hard gelatin capsules with opaque lavender coloured cap and opaque iron grey coloured body, imprinted on cap ‘OMEPRAZOLE’ 20 mgand on body ‘R158’ with black ink. The capsules are supplied in bottles of 30, 90, 100, 1000 and unit-dose packages of 100 (10 x 10). Bottles of 30 NDC 55111-158-30 NDC 55111-158-34 Bottles of 90 NDC 55111-158-90 Bottles of 100 NDC 55111-158-01 Bottles of 1000 NDC 55111-158-10 Unit-dose packages of 100 (10 x 10) NDC 55111-158-78 Omeprazole delayed-release capsules, USP 40 mg are off-white to pale yellow, elliptical to spherical pellets filled in size ‘Oel’ hard gelatin capsules with opaque yellow coloured cap and opaque lavender coloured body, imprinted on cap ‘OMEPRAZOLE’ 40 mg and on body ‘R159’ with black ink. The capsules are supplied in bottles of 30, 100, 500 and unit-dose packages of 100 (10 x 10). Bottles of 30 NDC 55111-159-30 Bottles of 100 NDC 55111-159-01 Bottles of 500 NDC 55111-159-05 Unit-dose packages of 100 (10 x 10) NDC 55111-159-78 StorageStore omeprazole delayed-release capsules in a tight container protected from light and moisture. Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].Omeprazole delayed-release capsules, USP 10 mg are off-white to pale yellow, elliptical to spherical pellets filled in size ‘3’ hard gelatin capsules with opaque lavender coloured cap and opaque yellow coloured body, imprinted on cap ‘OMEPRAZOLE’ 10 mg and on body ‘R157’ with black ink. The capsules are supplied in bottles of 30, 100, 1000 and unit-dose packages of 100 (10 x 10). Bottles of 30 NDC 55111-157-30 Bottles of 100 NDC 55111-157-01 Bottles of 1000 NDC 55111-157-10 Unit-dose packages of 100 (10 x 10) NDC 55111-157-78 Omeprazole delayed-release capsules, USP 20 mg are off-white to pale yellow, elliptical to spherical pellets filled in size ‘2’ hard gelatin capsules with opaque lavender coloured cap and opaque iron grey coloured body, imprinted on cap ‘OMEPRAZOLE’ 20 mgand on body ‘R158’ with black ink. The capsules are supplied in bottles of 30, 90, 100, 1000 and unit-dose packages of 100 (10 x 10). Bottles of 30 NDC 55111-158-30 NDC 55111-158-34 Bottles of 90 NDC 55111-158-90 Bottles of 100 NDC 55111-158-01 Bottles of 1000 NDC 55111-158-10 Unit-dose packages of 100 (10 x 10) NDC 55111-158-78 Omeprazole delayed-release capsules, USP 40 mg are off-white to pale yellow, elliptical to spherical pellets filled in size ‘Oel’ hard gelatin capsules with opaque yellow coloured cap and opaque lavender coloured body, imprinted on cap ‘OMEPRAZOLE’ 40 mg and on body ‘R159’ with black ink. The capsules are supplied in bottles of 30, 100, 500 and unit-dose packages of 100 (10 x 10). Bottles of 30 NDC 55111-159-30 Bottles of 100 NDC 55111-159-01 Bottles of 500 NDC 55111-159-05 Unit-dose packages of 100 (10 x 10) NDC 55111-159-78 StorageStore omeprazole delayed-release capsules in a tight container protected from light and moisture. Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].Omeprazole delayed-release capsules, USP 10 mg are off-white to pale yellow, elliptical to spherical pellets filled in size ‘3’ hard gelatin capsules with opaque lavender coloured cap and opaque yellow coloured body, imprinted on cap ‘OMEPRAZOLE’ 10 mg and on body ‘R157’ with black ink. The capsules are supplied in bottles of 30, 100, 1000 and unit-dose packages of 100 (10 x 10). Bottles of 30 NDC 55111-157-30 Bottles of 100 NDC 55111-157-01 Bottles of 1000 NDC 55111-157-10 Unit-dose packages of 100 (10 x 10) NDC 55111-157-78 Omeprazole delayed-release capsules, USP 20 mg are off-white to pale yellow, elliptical to spherical pellets filled in size ‘2’ hard gelatin capsules with opaque lavender coloured cap and opaque iron grey coloured body, imprinted on cap ‘OMEPRAZOLE’ 20 mgand on body ‘R158’ with black ink. The capsules are supplied in bottles of 30, 90, 100, 1000 and unit-dose packages of 100 (10 x 10). Bottles of 30 NDC 55111-158-30 NDC 55111-158-34 Bottles of 90 NDC 55111-158-90 Bottles of 100 NDC 55111-158-01 Bottles of 1000 NDC 55111-158-10 Unit-dose packages of 100 (10 x 10) NDC 55111-158-78 Omeprazole delayed-release capsules, USP 40 mg are off-white to pale yellow, elliptical to spherical pellets filled in size ‘Oel’ hard gelatin capsules with opaque yellow coloured cap and opaque lavender coloured body, imprinted on cap ‘OMEPRAZOLE’ 40 mg and on body ‘R159’ with black ink. The capsules are supplied in bottles of 30, 100, 500 and unit-dose packages of 100 (10 x 10). Bottles of 30 NDC 55111-159-30 Bottles of 100 NDC 55111-159-01 Bottles of 500 NDC 55111-159-05 Unit-dose packages of 100 (10 x 10) NDC 55111-159-78 StorageStore omeprazole delayed-release capsules in a tight container protected from light and moisture. Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].Omeprazole delayed-release capsules, USP 10 mg are off-white to pale yellow, elliptical to spherical pellets filled in size ‘3’ hard gelatin capsules with opaque lavender coloured cap and opaque yellow coloured body, imprinted on cap ‘OMEPRAZOLE’ 10 mg and on body ‘R157’ with black ink. The capsules are supplied in bottles of 30, 100, 1000 and unit-dose packages of 100 (10 x 10). Bottles of 30 NDC 55111-157-30 Bottles of 100 NDC 55111-157-01 Bottles of 1000 NDC 55111-157-10 Unit-dose packages of 100 (10 x 10) NDC 55111-157-78 Omeprazole delayed-release capsules, USP 20 mg are off-white to pale yellow, elliptical to spherical pellets filled in size ‘2’ hard gelatin capsules with opaque lavender coloured cap and opaque iron grey coloured body, imprinted on cap ‘OMEPRAZOLE’ 20 mgand on body ‘R158’ with black ink. The capsules are supplied in bottles of 30, 90, 100, 1000 and unit-dose packages of 100 (10 x 10). Bottles of 30 NDC 55111-158-30 NDC 55111-158-34 Bottles of 90 NDC 55111-158-90 Bottles of 100 NDC 55111-158-01 Bottles of 1000 NDC 55111-158-10 Unit-dose packages of 100 (10 x 10) NDC 55111-158-78 Omeprazole delayed-release capsules, USP 40 mg are off-white to pale yellow, elliptical to spherical pellets filled in size ‘Oel’ hard gelatin capsules with opaque yellow coloured cap and opaque lavender coloured body, imprinted on cap ‘OMEPRAZOLE’ 40 mg and on body ‘R159’ with black ink. The capsules are supplied in bottles of 30, 100, 500 and unit-dose packages of 100 (10 x 10). Bottles of 30 NDC 55111-159-30 Bottles of 100 NDC 55111-159-01 Bottles of 500 NDC 55111-159-05 Unit-dose packages of 100 (10 x 10) NDC 55111-159-78 StorageStore omeprazole delayed-release capsules in a tight container protected from light and moisture. Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].Omeprazole delayed-release capsules, USP 10 mg are off-white to pale yellow, elliptical to spherical pellets filled in size ‘3’ hard gelatin capsules with opaque lavender coloured cap and opaque yellow coloured body, imprinted on cap ‘OMEPRAZOLE’ 10 mg and on body ‘R157’ with black ink. The capsules are supplied in bottles of 30, 100, 1000 and unit-dose packages of 100 (10 x 10). Bottles of 30 NDC 55111-157-30 Bottles of 100 NDC 55111-157-01 Bottles of 1000 NDC 55111-157-10 Unit-dose packages of 100 (10 x 10) NDC 55111-157-78 Omeprazole delayed-release capsules, USP 20 mg are off-white to pale yellow, elliptical to spherical pellets filled in size ‘2’ hard gelatin capsules with opaque lavender coloured cap and opaque iron grey coloured body, imprinted on cap ‘OMEPRAZOLE’ 20 mgand on body ‘R158’ with black ink. The capsules are supplied in bottles of 30, 90, 100, 1000 and unit-dose packages of 100 (10 x 10). Bottles of 30 NDC 55111-158-30 NDC 55111-158-34 Bottles of 90 NDC 55111-158-90 Bottles of 100 NDC 55111-158-01 Bottles of 1000 NDC 55111-158-10 Unit-dose packages of 100 (10 x 10) NDC 55111-158-78 Omeprazole delayed-release capsules, USP 40 mg are off-white to pale yellow, elliptical to spherical pellets filled in size ‘Oel’ hard gelatin capsules with opaque yellow coloured cap and opaque lavender coloured body, imprinted on cap ‘OMEPRAZOLE’ 40 mg and on body ‘R159’ with black ink. The capsules are supplied in bottles of 30, 100, 500 and unit-dose packages of 100 (10 x 10). Bottles of 30 NDC 55111-159-30 Bottles of 100 NDC 55111-159-01 Bottles of 500 NDC 55111-159-05 Unit-dose packages of 100 (10 x 10) NDC 55111-159-78 StorageStore omeprazole delayed-release capsules in a tight container protected from light and moisture. Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].Omeprazole delayed-release capsules, USP 10 mg are off-white to pale yellow, elliptical to spherical pellets filled in size ‘3’ hard gelatin capsules with opaque lavender coloured cap and opaque yellow coloured body, imprinted on cap ‘OMEPRAZOLE’ 10 mg and on body ‘R157’ with black ink. The capsules are supplied in bottles of 30, 100, 1000 and unit-dose packages of 100 (10 x 10). Bottles of 30 NDC 55111-157-30 Bottles of 100 NDC 55111-157-01 Bottles of 1000 NDC 55111-157-10 Unit-dose packages of 100 (10 x 10) NDC 55111-157-78 Omeprazole delayed-release capsules, USP 20 mg are off-white to pale yellow, elliptical to spherical pellets filled in size ‘2’ hard gelatin capsules with opaque lavender coloured cap and opaque iron grey coloured body, imprinted on cap ‘OMEPRAZOLE’ 20 mgand on body ‘R158’ with black ink. The capsules are supplied in bottles of 30, 90, 100, 1000 and unit-dose packages of 100 (10 x 10). Bottles of 30 NDC 55111-158-30 NDC 55111-158-34 Bottles of 90 NDC 55111-158-90 Bottles of 100 NDC 55111-158-01 Bottles of 1000 NDC 55111-158-10 Unit-dose packages of 100 (10 x 10) NDC 55111-158-78 Omeprazole delayed-release capsules, USP 40 mg are off-white to pale yellow, elliptical to spherical pellets filled in size ‘Oel’ hard gelatin capsules with opaque yellow coloured cap and opaque lavender coloured body, imprinted on cap ‘OMEPRAZOLE’ 40 mg and on body ‘R159’ with black ink. The capsules are supplied in bottles of 30, 100, 500 and unit-dose packages of 100 (10 x 10). Bottles of 30 NDC 55111-159-30 Bottles of 100 NDC 55111-159-01 Bottles of 500 NDC 55111-159-05 Unit-dose packages of 100 (10 x 10) NDC 55111-159-78 StorageStore omeprazole delayed-release capsules in a tight container protected from light and moisture. Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].Omeprazole delayed-release capsules, USP 10 mg are off-white to pale yellow, elliptical to spherical pellets filled in size ‘3’ hard gelatin capsules with opaque lavender coloured cap and opaque yellow coloured body, imprinted on cap ‘OMEPRAZOLE’ 10 mg and on body ‘R157’ with black ink. The capsules are supplied in bottles of 30, 100, 1000 and unit-dose packages of 100 (10 x 10). Bottles of 30 NDC 55111-157-30 Bottles of 100 NDC 55111-157-01 Bottles of 1000 NDC 55111-157-10 Unit-dose packages of 100 (10 x 10) NDC 55111-157-78 Omeprazole delayed-release capsules, USP 20 mg are off-white to pale yellow, elliptical to spherical pellets filled in size ‘2’ hard gelatin capsules with opaque lavender coloured cap and opaque iron grey coloured body, imprinted on cap ‘OMEPRAZOLE’ 20 mgand on body ‘R158’ with black ink. The capsules are supplied in bottles of 30, 90, 100, 1000 and unit-dose packages of 100 (10 x 10). Bottles of 30 NDC 55111-158-30 NDC 55111-158-34 Bottles of 90 NDC 55111-158-90 Bottles of 100 NDC 55111-158-01 Bottles of 1000 NDC 55111-158-10 Unit-dose packages of 100 (10 x 10) NDC 55111-158-78 Omeprazole delayed-release capsules, USP 40 mg are off-white to pale yellow, elliptical to spherical pellets filled in size ‘Oel’ hard gelatin capsules with opaque yellow coloured cap and opaque lavender coloured body, imprinted on cap ‘OMEPRAZOLE’ 40 mg and on body ‘R159’ with black ink. The capsules are supplied in bottles of 30, 100, 500 and unit-dose packages of 100 (10 x 10). Bottles of 30 NDC 55111-159-30 Bottles of 100 NDC 55111-159-01 Bottles of 500 NDC 55111-159-05 Unit-dose packages of 100 (10 x 10) NDC 55111-159-78 StorageStore omeprazole delayed-release capsules in a tight container protected from light and moisture. Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].Omeprazole delayed-release capsules, USP 10 mg are off-white to pale yellow, elliptical to spherical pellets filled in size ‘3’ hard gelatin capsules with opaque lavender coloured cap and opaque yellow coloured body, imprinted on cap ‘OMEPRAZOLE’ 10 mg and on body ‘R157’ with black ink. The capsules are supplied in bottles of 30, 100, 1000 and unit-dose packages of 100 (10 x 10). Bottles of 30 NDC 55111-157-30 Bottles of 100 NDC 55111-157-01 Bottles of 1000 NDC 55111-157-10 Unit-dose packages of 100 (10 x 10) NDC 55111-157-78 Omeprazole delayed-release capsules, USP 20 mg are off-white to pale yellow, elliptical to spherical pellets filled in size ‘2’ hard gelatin capsules with opaque lavender coloured cap and opaque iron grey coloured body, imprinted on cap ‘OMEPRAZOLE’ 20 mgand on body ‘R158’ with black ink. The capsules are supplied in bottles of 30, 90, 100, 1000 and unit-dose packages of 100 (10 x 10). Bottles of 30 NDC 55111-158-30 NDC 55111-158-34 Bottles of 90 NDC 55111-158-90 Bottles of 100 NDC 55111-158-01 Bottles of 1000 NDC 55111-158-10 Unit-dose packages of 100 (10 x 10) NDC 55111-158-78 Omeprazole delayed-release capsules, USP 40 mg are off-white to pale yellow, elliptical to spherical pellets filled in size ‘Oel’ hard gelatin capsules with opaque yellow coloured cap and opaque lavender coloured body, imprinted on cap ‘OMEPRAZOLE’ 40 mg and on body ‘R159’ with black ink. The capsules are supplied in bottles of 30, 100, 500 and unit-dose packages of 100 (10 x 10). Bottles of 30 NDC 55111-159-30 Bottles of 100 NDC 55111-159-01 Bottles of 500 NDC 55111-159-05 Unit-dose packages of 100 (10 x 10) NDC 55111-159-78 StorageStore omeprazole delayed-release capsules in a tight container protected from light and moisture. Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].Omeprazole delayed-release capsules, USP 10 mg are off-white to pale yellow, elliptical to spherical pellets filled in size ‘3’ hard gelatin capsules with opaque lavender coloured cap and opaque yellow coloured body, imprinted on cap ‘OMEPRAZOLE’ 10 mg and on body ‘R157’ with black ink. The capsules are supplied in bottles of 30, 100, 1000 and unit-dose packages of 100 (10 x 10). Bottles of 30 NDC 55111-157-30 Bottles of 100 NDC 55111-157-01 Bottles of 1000 NDC 55111-157-10 Unit-dose packages of 100 (10 x 10) NDC 55111-157-78 Omeprazole delayed-release capsules, USP 20 mg are off-white to pale yellow, elliptical to spherical pellets filled in size ‘2’ hard gelatin capsules with opaque lavender coloured cap and opaque iron grey coloured body, imprinted on cap ‘OMEPRAZOLE’ 20 mgand on body ‘R158’ with black ink. The capsules are supplied in bottles of 30, 90, 100, 1000 and unit-dose packages of 100 (10 x 10). Bottles of 30 NDC 55111-158-30 NDC 55111-158-34 Bottles of 90 NDC 55111-158-90 Bottles of 100 NDC 55111-158-01 Bottles of 1000 NDC 55111-158-10 Unit-dose packages of 100 (10 x 10) NDC 55111-158-78 Omeprazole delayed-release capsules, USP 40 mg are off-white to pale yellow, elliptical to spherical pellets filled in size ‘Oel’ hard gelatin capsules with opaque yellow coloured cap and opaque lavender coloured body, imprinted on cap ‘OMEPRAZOLE’ 40 mg and on body ‘R159’ with black ink. The capsules are supplied in bottles of 30, 100, 500 and unit-dose packages of 100 (10 x 10). Bottles of 30 NDC 55111-159-30 Bottles of 100 NDC 55111-159-01 Bottles of 500 NDC 55111-159-05 Unit-dose packages of 100 (10 x 10) NDC 55111-159-78 StorageStore omeprazole delayed-release capsules in a tight container protected from light and moisture. Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].Omeprazole delayed-release capsules, USP 10 mg are off-white to pale yellow, elliptical to spherical pellets filled in size ‘3’ hard gelatin capsules with opaque lavender coloured cap and opaque yellow coloured body, imprinted on cap ‘OMEPRAZOLE’ 10 mg and on body ‘R157’ with black ink. The capsules are supplied in bottles of 30, 100, 1000 and unit-dose packages of 100 (10 x 10). Bottles of 30 NDC 55111-157-30 Bottles of 100 NDC 55111-157-01 Bottles of 1000 NDC 55111-157-10 Unit-dose packages of 100 (10 x 10) NDC 55111-157-78 Omeprazole delayed-release capsules, USP 20 mg are off-white to pale yellow, elliptical to spherical pellets filled in size ‘2’ hard gelatin capsules with opaque lavender coloured cap and opaque iron grey coloured body, imprinted on cap ‘OMEPRAZOLE’ 20 mgand on body ‘R158’ with black ink. The capsules are supplied in bottles of 30, 90, 100, 1000 and unit-dose packages of 100 (10 x 10). Bottles of 30 NDC 55111-158-30 NDC 55111-158-34 Bottles of 90 NDC 55111-158-90 Bottles of 100 NDC 55111-158-01 Bottles of 1000 NDC 55111-158-10 Unit-dose packages of 100 (10 x 10) NDC 55111-158-78 Omeprazole delayed-release capsules, USP 40 mg are off-white to pale yellow, elliptical to spherical pellets filled in size ‘Oel’ hard gelatin capsules with opaque yellow coloured cap and opaque lavender coloured body, imprinted on cap ‘OMEPRAZOLE’ 40 mg and on body ‘R159’ with black ink. The capsules are supplied in bottles of 30, 100, 500 and unit-dose packages of 100 (10 x 10). Bottles of 30 NDC 55111-159-30 Bottles of 100 NDC 55111-159-01 Bottles of 500 NDC 55111-159-05 Unit-dose packages of 100 (10 x 10) NDC 55111-159-78 StorageStore omeprazole delayed-release capsules in a tight container protected from light and moisture. Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].Omeprazole delayed-release capsules, USP 10 mg are off-white to pale yellow, elliptical to spherical pellets filled in size ‘3’ hard gelatin capsules with opaque lavender coloured cap and opaque yellow coloured body, imprinted on cap ‘OMEPRAZOLE’ 10 mg and on body ‘R157’ with black ink. The capsules are supplied in bottles of 30, 100, 1000 and unit-dose packages of 100 (10 x 10). Bottles of 30 NDC 55111-157-30 Bottles of 100 NDC 55111-157-01 Bottles of 1000 NDC 55111-157-10 Unit-dose packages of 100 (10 x 10) NDC 55111-157-78 Omeprazole delayed-release capsules, USP 20 mg are off-white to pale yellow, elliptical to spherical pellets filled in size ‘2’ hard gelatin capsules with opaque lavender coloured cap and opaque iron grey coloured body, imprinted on cap ‘OMEPRAZOLE’ 20 mgand on body ‘R158’ with black ink. The capsules are supplied in bottles of 30, 90, 100, 1000 and unit-dose packages of 100 (10 x 10). Bottles of 30 NDC 55111-158-30 NDC 55111-158-34 Bottles of 90 NDC 55111-158-90 Bottles of 100 NDC 55111-158-01 Bottles of 1000 NDC 55111-158-10 Unit-dose packages of 100 (10 x 10) NDC 55111-158-78 Omeprazole delayed-release capsules, USP 40 mg are off-white to pale yellow, elliptical to spherical pellets filled in size ‘Oel’ hard gelatin capsules with opaque yellow coloured cap and opaque lavender coloured body, imprinted on cap ‘OMEPRAZOLE’ 40 mg and on body ‘R159’ with black ink. The capsules are supplied in bottles of 30, 100, 500 and unit-dose packages of 100 (10 x 10). Bottles of 30 NDC 55111-159-30 Bottles of 100 NDC 55111-159-01 Bottles of 500 NDC 55111-159-05 Unit-dose packages of 100 (10 x 10) NDC 55111-159-78 StorageStore omeprazole delayed-release capsules in a tight container protected from light and moisture. Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].Omeprazole delayed-release capsules, USP 10 mg are off-white to pale yellow, elliptical to spherical pellets filled in size ‘3’ hard gelatin capsules with opaque lavender coloured cap and opaque yellow coloured body, imprinted on cap ‘OMEPRAZOLE’ 10 mg and on body ‘R157’ with black ink. The capsules are supplied in bottles of 30, 100, 1000 and unit-dose packages of 100 (10 x 10). Bottles of 30 NDC 55111-157-30 Bottles of 100 NDC 55111-157-01 Bottles of 1000 NDC 55111-157-10 Unit-dose packages of 100 (10 x 10) NDC 55111-157-78 Omeprazole delayed-release capsules, USP 20 mg are off-white to pale yellow, elliptical to spherical pellets filled in size ‘2’ hard gelatin capsules with opaque lavender coloured cap and opaque iron grey coloured body, imprinted on cap ‘OMEPRAZOLE’ 20 mgand on body ‘R158’ with black ink. The capsules are supplied in bottles of 30, 90, 100, 1000 and unit-dose packages of 100 (10 x 10). Bottles of 30 NDC 55111-158-30 NDC 55111-158-34 Bottles of 90 NDC 55111-158-90 Bottles of 100 NDC 55111-158-01 Bottles of 1000 NDC 55111-158-10 Unit-dose packages of 100 (10 x 10) NDC 55111-158-78 Omeprazole delayed-release capsules, USP 40 mg are off-white to pale yellow, elliptical to spherical pellets filled in size ‘Oel’ hard gelatin capsules with opaque yellow coloured cap and opaque lavender coloured body, imprinted on cap ‘OMEPRAZOLE’ 40 mg and on body ‘R159’ with black ink. The capsules are supplied in bottles of 30, 100, 500 and unit-dose packages of 100 (10 x 10). Bottles of 30 NDC 55111-159-30 Bottles of 100 NDC 55111-159-01 Bottles of 500 NDC 55111-159-05 Unit-dose packages of 100 (10 x 10) NDC 55111-159-78 StorageStore omeprazole delayed-release capsules in a tight container protected from light and moisture. Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].Omeprazole delayed-release capsules, USP 10 mg are off-white to pale yellow, elliptical to spherical pellets filled in size ‘3’ hard gelatin capsules with opaque lavender coloured cap and opaque yellow coloured body, imprinted on cap ‘OMEPRAZOLE’ 10 mg and on body ‘R157’ with black ink. The capsules are supplied in bottles of 30, 100, 1000 and unit-dose packages of 100 (10 x 10). Bottles of 30 NDC 55111-157-30 Bottles of 100 NDC 55111-157-01 Bottles of 1000 NDC 55111-157-10 Unit-dose packages of 100 (10 x 10) NDC 55111-157-78 Omeprazole delayed-release capsules, USP 20 mg are off-white to pale yellow, elliptical to spherical pellets filled in size ‘2’ hard gelatin capsules with opaque lavender coloured cap and opaque iron grey coloured body, imprinted on cap ‘OMEPRAZOLE’ 20 mgand on body ‘R158’ with black ink. The capsules are supplied in bottles of 30, 90, 100, 1000 and unit-dose packages of 100 (10 x 10). Bottles of 30 NDC 55111-158-30 NDC 55111-158-34 Bottles of 90 NDC 55111-158-90 Bottles of 100 NDC 55111-158-01 Bottles of 1000 NDC 55111-158-10 Unit-dose packages of 100 (10 x 10) NDC 55111-158-78 Omeprazole delayed-release capsules, USP 40 mg are off-white to pale yellow, elliptical to spherical pellets filled in size ‘Oel’ hard gelatin capsules with opaque yellow coloured cap and opaque lavender coloured body, imprinted on cap ‘OMEPRAZOLE’ 40 mg and on body ‘R159’ with black ink. The capsules are supplied in bottles of 30, 100, 500 and unit-dose packages of 100 (10 x 10). Bottles of 30 NDC 55111-159-30 Bottles of 100 NDC 55111-159-01 Bottles of 500 NDC 55111-159-05 Unit-dose packages of 100 (10 x 10) NDC 55111-159-78 StorageStore omeprazole delayed-release capsules in a tight container protected from light and moisture. Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].Omeprazole delayed-release capsules, USP 10 mg are off-white to pale yellow, elliptical to spherical pellets filled in size ‘3’ hard gelatin capsules with opaque lavender coloured cap and opaque yellow coloured body, imprinted on cap ‘OMEPRAZOLE’ 10 mg and on body ‘R157’ with black ink. The capsules are supplied in bottles of 30, 100, 1000 and unit-dose packages of 100 (10 x 10). Bottles of 30 NDC 55111-157-30 Bottles of 100 NDC 55111-157-01 Bottles of 1000 NDC 55111-157-10 Unit-dose packages of 100 (10 x 10) NDC 55111-157-78 Omeprazole delayed-release capsules, USP 20 mg are off-white to pale yellow, elliptical to spherical pellets filled in size ‘2’ hard gelatin capsules with opaque lavender coloured cap and opaque iron grey coloured body, imprinted on cap ‘OMEPRAZOLE’ 20 mgand on body ‘R158’ with black ink. The capsules are supplied in bottles of 30, 90, 100, 1000 and unit-dose packages of 100 (10 x 10). Bottles of 30 NDC 55111-158-30 NDC 55111-158-34 Bottles of 90 NDC 55111-158-90 Bottles of 100 NDC 55111-158-01 Bottles of 1000 NDC 55111-158-10 Unit-dose packages of 100 (10 x 10) NDC 55111-158-78 Omeprazole delayed-release capsules, USP 40 mg are off-white to pale yellow, elliptical to spherical pellets filled in size ‘Oel’ hard gelatin capsules with opaque yellow coloured cap and opaque lavender coloured body, imprinted on cap ‘OMEPRAZOLE’ 40 mg and on body ‘R159’ with black ink. The capsules are supplied in bottles of 30, 100, 500 and unit-dose packages of 100 (10 x 10). Bottles of 30 NDC 55111-159-30 Bottles of 100 NDC 55111-159-01 Bottles of 500 NDC 55111-159-05 Unit-dose packages of 100 (10 x 10) NDC 55111-159-78 StorageStore omeprazole delayed-release capsules in a tight container protected from light and moisture. Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].Omeprazole delayed-release capsules, USP 10 mg are off-white to pale yellow, elliptical to spherical pellets filled in size ‘3’ hard gelatin capsules with opaque lavender coloured cap and opaque yellow coloured body, imprinted on cap ‘OMEPRAZOLE’ 10 mg and on body ‘R157’ with black ink. The capsules are supplied in bottles of 30, 100, 1000 and unit-dose packages of 100 (10 x 10). Bottles of 30 NDC 55111-157-30 Bottles of 100 NDC 55111-157-01 Bottles of 1000 NDC 55111-157-10 Unit-dose packages of 100 (10 x 10) NDC 55111-157-78 Omeprazole delayed-release capsules, USP 20 mg are off-white to pale yellow, elliptical to spherical pellets filled in size ‘2’ hard gelatin capsules with opaque lavender coloured cap and opaque iron grey coloured body, imprinted on cap ‘OMEPRAZOLE’ 20 mgand on body ‘R158’ with black ink. The capsules are supplied in bottles of 30, 90, 100, 1000 and unit-dose packages of 100 (10 x 10). Bottles of 30 NDC 55111-158-30 NDC 55111-158-34 Bottles of 90 NDC 55111-158-90 Bottles of 100 NDC 55111-158-01 Bottles of 1000 NDC 55111-158-10 Unit-dose packages of 100 (10 x 10) NDC 55111-158-78 Omeprazole delayed-release capsules, USP 40 mg are off-white to pale yellow, elliptical to spherical pellets filled in size ‘Oel’ hard gelatin capsules with opaque yellow coloured cap and opaque lavender coloured body, imprinted on cap ‘OMEPRAZOLE’ 40 mg and on body ‘R159’ with black ink. The capsules are supplied in bottles of 30, 100, 500 and unit-dose packages of 100 (10 x 10). Bottles of 30 NDC 55111-159-30 Bottles of 100 NDC 55111-159-01 Bottles of 500 NDC 55111-159-05 Unit-dose packages of 100 (10 x 10) NDC 55111-159-78 StorageStore omeprazole delayed-release capsules in a tight container protected from light and moisture. Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].Omeprazole delayed-release capsules, USP 10 mg are off-white to pale yellow, elliptical to spherical pellets filled in size ‘3’ hard gelatin capsules with opaque lavender coloured cap and opaque yellow coloured body, imprinted on cap ‘OMEPRAZOLE’ 10 mg and on body ‘R157’ with black ink. The capsules are supplied in bottles of 30, 100, 1000 and unit-dose packages of 100 (10 x 10). Bottles of 30 NDC 55111-157-30 Bottles of 100 NDC 55111-157-01 Bottles of 1000 NDC 55111-157-10 Unit-dose packages of 100 (10 x 10) NDC 55111-157-78 Omeprazole delayed-release capsules, USP 20 mg are off-white to pale yellow, elliptical to spherical pellets filled in size ‘2’ hard gelatin capsules with opaque lavender coloured cap and opaque iron grey coloured body, imprinted on cap ‘OMEPRAZOLE’ 20 mgand on body ‘R158’ with black ink. The capsules are supplied in bottles of 30, 90, 100, 1000 and unit-dose packages of 100 (10 x 10). Bottles of 30 NDC 55111-158-30 NDC 55111-158-34 Bottles of 90 NDC 55111-158-90 Bottles of 100 NDC 55111-158-01 Bottles of 1000 NDC 55111-158-10 Unit-dose packages of 100 (10 x 10) NDC 55111-158-78 Omeprazole delayed-release capsules, USP 40 mg are off-white to pale yellow, elliptical to spherical pellets filled in size ‘Oel’ hard gelatin capsules with opaque yellow coloured cap and opaque lavender coloured body, imprinted on cap ‘OMEPRAZOLE’ 40 mg and on body ‘R159’ with black ink. The capsules are supplied in bottles of 30, 100, 500 and unit-dose packages of 100 (10 x 10). Bottles of 30 NDC 55111-159-30 Bottles of 100 NDC 55111-159-01 Bottles of 500 NDC 55111-159-05 Unit-dose packages of 100 (10 x 10) NDC 55111-159-78 StorageStore omeprazole delayed-release capsules in a tight container protected from light and moisture. Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].Omeprazole delayed-release capsules, USP 10 mg are off-white to pale yellow, elliptical to spherical pellets filled in size ‘3’ hard gelatin capsules with opaque lavender coloured cap and opaque yellow coloured body, imprinted on cap ‘OMEPRAZOLE’ 10 mg and on body ‘R157’ with black ink. The capsules are supplied in bottles of 30, 100, 1000 and unit-dose packages of 100 (10 x 10). Bottles of 30 NDC 55111-157-30 Bottles of 100 NDC 55111-157-01 Bottles of 1000 NDC 55111-157-10 Unit-dose packages of 100 (10 x 10) NDC 55111-157-78 Omeprazole delayed-release capsules, USP 20 mg are off-white to pale yellow, elliptical to spherical pellets filled in size ‘2’ hard gelatin capsules with opaque lavender coloured cap and opaque iron grey coloured body, imprinted on cap ‘OMEPRAZOLE’ 20 mgand on body ‘R158’ with black ink. The capsules are supplied in bottles of 30, 90, 100, 1000 and unit-dose packages of 100 (10 x 10). Bottles of 30 NDC 55111-158-30 NDC 55111-158-34 Bottles of 90 NDC 55111-158-90 Bottles of 100 NDC 55111-158-01 Bottles of 1000 NDC 55111-158-10 Unit-dose packages of 100 (10 x 10) NDC 55111-158-78 Omeprazole delayed-release capsules, USP 40 mg are off-white to pale yellow, elliptical to spherical pellets filled in size ‘Oel’ hard gelatin capsules with opaque yellow coloured cap and opaque lavender coloured body, imprinted on cap ‘OMEPRAZOLE’ 40 mg and on body ‘R159’ with black ink. The capsules are supplied in bottles of 30, 100, 500 and unit-dose packages of 100 (10 x 10). Bottles of 30 NDC 55111-159-30 Bottles of 100 NDC 55111-159-01 Bottles of 500 NDC 55111-159-05 Unit-dose packages of 100 (10 x 10) NDC 55111-159-78 StorageStore omeprazole delayed-release capsules in a tight container protected from light and moisture. Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].Omeprazole delayed-release capsules, USP 10 mg are off-white to pale yellow, elliptical to spherical pellets filled in size ‘3’ hard gelatin capsules with opaque lavender coloured cap and opaque yellow coloured body, imprinted on cap ‘OMEPRAZOLE’ 10 mg and on body ‘R157’ with black ink. The capsules are supplied in bottles of 30, 100, 1000 and unit-dose packages of 100 (10 x 10). Bottles of 30 NDC 55111-157-30 Bottles of 100 NDC 55111-157-01 Bottles of 1000 NDC 55111-157-10 Unit-dose packages of 100 (10 x 10) NDC 55111-157-78 Omeprazole delayed-release capsules, USP 20 mg are off-white to pale yellow, elliptical to spherical pellets filled in size ‘2’ hard gelatin capsules with opaque lavender coloured cap and opaque iron grey coloured body, imprinted on cap ‘OMEPRAZOLE’ 20 mgand on body ‘R158’ with black ink. The capsules are supplied in bottles of 30, 90, 100, 1000 and unit-dose packages of 100 (10 x 10). Bottles of 30 NDC 55111-158-30 NDC 55111-158-34 Bottles of 90 NDC 55111-158-90 Bottles of 100 NDC 55111-158-01 Bottles of 1000 NDC 55111-158-10 Unit-dose packages of 100 (10 x 10) NDC 55111-158-78 Omeprazole delayed-release capsules, USP 40 mg are off-white to pale yellow, elliptical to spherical pellets filled in size ‘Oel’ hard gelatin capsules with opaque yellow coloured cap and opaque lavender coloured body, imprinted on cap ‘OMEPRAZOLE’ 40 mg and on body ‘R159’ with black ink. The capsules are supplied in bottles of 30, 100, 500 and unit-dose packages of 100 (10 x 10). Bottles of 30 NDC 55111-159-30 Bottles of 100 NDC 55111-159-01 Bottles of 500 NDC 55111-159-05 Unit-dose packages of 100 (10 x 10) NDC 55111-159-78 StorageStore omeprazole delayed-release capsules in a tight container protected from light and moisture. Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].Omeprazole delayed-release capsules, USP 10 mg are off-white to pale yellow, elliptical to spherical pellets filled in size ‘3’ hard gelatin capsules with opaque lavender coloured cap and opaque yellow coloured body, imprinted on cap ‘OMEPRAZOLE’ 10 mg and on body ‘R157’ with black ink. The capsules are supplied in bottles of 30, 100, 1000 and unit-dose packages of 100 (10 x 10). Bottles of 30 NDC 55111-157-30 Bottles of 100 NDC 55111-157-01 Bottles of 1000 NDC 55111-157-10 Unit-dose packages of 100 (10 x 10) NDC 55111-157-78 Omeprazole delayed-release capsules, USP 20 mg are off-white to pale yellow, elliptical to spherical pellets filled in size ‘2’ hard gelatin capsules with opaque lavender coloured cap and opaque iron grey coloured body, imprinted on cap ‘OMEPRAZOLE’ 20 mgand on body ‘R158’ with black ink. The capsules are supplied in bottles of 30, 90, 100, 1000 and unit-dose packages of 100 (10 x 10). Bottles of 30 NDC 55111-158-30 NDC 55111-158-34 Bottles of 90 NDC 55111-158-90 Bottles of 100 NDC 55111-158-01 Bottles of 1000 NDC 55111-158-10 Unit-dose packages of 100 (10 x 10) NDC 55111-158-78 Omeprazole delayed-release capsules, USP 40 mg are off-white to pale yellow, elliptical to spherical pellets filled in size ‘Oel’ hard gelatin capsules with opaque yellow coloured cap and opaque lavender coloured body, imprinted on cap ‘OMEPRAZOLE’ 40 mg and on body ‘R159’ with black ink. The capsules are supplied in bottles of 30, 100, 500 and unit-dose packages of 100 (10 x 10). Bottles of 30 NDC 55111-159-30 Bottles of 100 NDC 55111-159-01 Bottles of 500 NDC 55111-159-05 Unit-dose packages of 100 (10 x 10) NDC 55111-159-78 StorageStore omeprazole delayed-release capsules in a tight container protected from light and moisture. Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].Omeprazole delayed-release capsules, USP 10 mg are off-white to pale yellow, elliptical to spherical pellets filled in size ‘3’ hard gelatin capsules with opaque lavender coloured cap and opaque yellow coloured body, imprinted on cap ‘OMEPRAZOLE’ 10 mg and on body ‘R157’ with black ink. The capsules are supplied in bottles of 30, 100, 1000 and unit-dose packages of 100 (10 x 10). Bottles of 30 NDC 55111-157-30 Bottles of 100 NDC 55111-157-01 Bottles of 1000 NDC 55111-157-10 Unit-dose packages of 100 (10 x 10) NDC 55111-157-78 Omeprazole delayed-release capsules, USP 20 mg are off-white to pale yellow, elliptical to spherical pellets filled in size ‘2’ hard gelatin capsules with opaque lavender coloured cap and opaque iron grey coloured body, imprinted on cap ‘OMEPRAZOLE’ 20 mgand on body ‘R158’ with black ink. The capsules are supplied in bottles of 30, 90, 100, 1000 and unit-dose packages of 100 (10 x 10). Bottles of 30 NDC 55111-158-30 NDC 55111-158-34 Bottles of 90 NDC 55111-158-90 Bottles of 100 NDC 55111-158-01 Bottles of 1000 NDC 55111-158-10 Unit-dose packages of 100 (10 x 10) NDC 55111-158-78 Omeprazole delayed-release capsules, USP 40 mg are off-white to pale yellow, elliptical to spherical pellets filled in size ‘Oel’ hard gelatin capsules with opaque yellow coloured cap and opaque lavender coloured body, imprinted on cap ‘OMEPRAZOLE’ 40 mg and on body ‘R159’ with black ink. The capsules are supplied in bottles of 30, 100, 500 and unit-dose packages of 100 (10 x 10). Bottles of 30 NDC 55111-159-30 Bottles of 100 NDC 55111-159-01 Bottles of 500 NDC 55111-159-05 Unit-dose packages of 100 (10 x 10) NDC 55111-159-78 StorageStore omeprazole delayed-release capsules in a tight container protected from light and moisture. Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].Omeprazole delayed-release capsules, USP 10 mg are off-white to pale yellow, elliptical to spherical pellets filled in size ‘3’ hard gelatin capsules with opaque lavender coloured cap and opaque yellow coloured body, imprinted on cap ‘OMEPRAZOLE’ 10 mg and on body ‘R157’ with black ink. The capsules are supplied in bottles of 30, 100, 1000 and unit-dose packages of 100 (10 x 10). Bottles of 30 NDC 55111-157-30 Bottles of 100 NDC 55111-157-01 Bottles of 1000 NDC 55111-157-10 Unit-dose packages of 100 (10 x 10) NDC 55111-157-78 Omeprazole delayed-release capsules, USP 20 mg are off-white to pale yellow, elliptical to spherical pellets filled in size ‘2’ hard gelatin capsules with opaque lavender coloured cap and opaque iron grey coloured body, imprinted on cap ‘OMEPRAZOLE’ 20 mgand on body ‘R158’ with black ink. The capsules are supplied in bottles of 30, 90, 100, 1000 and unit-dose packages of 100 (10 x 10). Bottles of 30 NDC 55111-158-30 NDC 55111-158-34 Bottles of 90 NDC 55111-158-90 Bottles of 100 NDC 55111-158-01 Bottles of 1000 NDC 55111-158-10 Unit-dose packages of 100 (10 x 10) NDC 55111-158-78 Omeprazole delayed-release capsules, USP 40 mg are off-white to pale yellow, elliptical to spherical pellets filled in size ‘Oel’ hard gelatin capsules with opaque yellow coloured cap and opaque lavender coloured body, imprinted on cap ‘OMEPRAZOLE’ 40 mg and on body ‘R159’ with black ink. The capsules are supplied in bottles of 30, 100, 500 and unit-dose packages of 100 (10 x 10). Bottles of 30 NDC 55111-159-30 Bottles of 100 NDC 55111-159-01 Bottles of 500 NDC 55111-159-05 Unit-dose packages of 100 (10 x 10) NDC 55111-159-78 StorageStore omeprazole delayed-release capsules in a tight container protected from light and moisture. Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].Omeprazole delayed-release capsules, USP 10 mg are off-white to pale yellow, elliptical to spherical pellets filled in size ‘3’ hard gelatin capsules with opaque lavender coloured cap and opaque yellow coloured body, imprinted on cap ‘OMEPRAZOLE’ 10 mg and on body ‘R157’ with black ink. The capsules are supplied in bottles of 30, 100, 1000 and unit-dose packages of 100 (10 x 10). Bottles of 30 NDC 55111-157-30 Bottles of 100 NDC 55111-157-01 Bottles of 1000 NDC 55111-157-10 Unit-dose packages of 100 (10 x 10) NDC 55111-157-78 Omeprazole delayed-release capsules, USP 20 mg are off-white to pale yellow, elliptical to spherical pellets filled in size ‘2’ hard gelatin capsules with opaque lavender coloured cap and opaque iron grey coloured body, imprinted on cap ‘OMEPRAZOLE’ 20 mgand on body ‘R158’ with black ink. The capsules are supplied in bottles of 30, 90, 100, 1000 and unit-dose packages of 100 (10 x 10). Bottles of 30 NDC 55111-158-30 NDC 55111-158-34 Bottles of 90 NDC 55111-158-90 Bottles of 100 NDC 55111-158-01 Bottles of 1000 NDC 55111-158-10 Unit-dose packages of 100 (10 x 10) NDC 55111-158-78 Omeprazole delayed-release capsules, USP 40 mg are off-white to pale yellow, elliptical to spherical pellets filled in size ‘Oel’ hard gelatin capsules with opaque yellow coloured cap and opaque lavender coloured body, imprinted on cap ‘OMEPRAZOLE’ 40 mg and on body ‘R159’ with black ink. The capsules are supplied in bottles of 30, 100, 500 and unit-dose packages of 100 (10 x 10). Bottles of 30 NDC 55111-159-30 Bottles of 100 NDC 55111-159-01 Bottles of 500 NDC 55111-159-05 Unit-dose packages of 100 (10 x 10) NDC 55111-159-78 StorageStore omeprazole delayed-release capsules in a tight container protected from light and moisture. Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].
Clinical Information
Chemical Structure
No Image foundClinical Pharmacology
Non-Clinical Toxicology
KOMBIGLYZE XR is contraindicated in patients with:There has been a report of a patient who passed an orange rubbery precipitate in his stool the day after ingesting carbamazepine suspension immediately followed by Thorazine* solution. Subsequent testing has shown that mixing carbamazepine suspension and chlorpromazine solution (both generic and brand name) as well as carbamazepine suspension and liquid Mellaril, resulted in the occurrence of this precipitate. Because the extent to which this occurs with other liquid medications is not known, carbamazepine suspension should not be administered simultaneously with other liquid medicinal agents or diluents (See ).
Clinically meaningful drug interactions have occurred with concomitant medications and include (but are not limited to) the following:
There have been postmarketing cases of metformin-associated lactic acidosis, including fatal cases. These cases had a subtle onset and were accompanied by nonspecific symptoms such as malaise, myalgias, abdominal pain, respiratory distress, or increased somnolence; however, hypothermia, hypotension and resistant bradyarrhythmias have occurred with severe acidosis.
Metformin-associated lactic acidosis was characterized by elevated blood lactate concentrations (>5 mmol/Liter), anion gap acidosis (without evidence of ketonuria or ketonemia), and an increased lactate:pyruvate ratio; metformin plasma levels generally >5 mcg/mL. Metformin decreases liver uptake of lactate increasing lactate blood levels which may increase the risk of lactic acidosis, especially in patients at risk.
If metformin-associated lactic acidosis is suspected, general supportive measures should be instituted promptly in a hospital setting, along with immediate discontinuation of KOMBIGLYZE XR.
In KOMBIGLYZE XR-treated patients with a diagnosis or strong suspicion of lactic acidosis, prompt hemodialysis is recommended to correct the acidosis and remove accumulated metformin (metformin hydrochloride is dialyzable, with a clearance of up to 170 mL/minute under good hemodynamic conditions). Hemodialysis has often resulted in reversal of symptoms and recovery.
Educate patients and their families about the symptoms of lactic acidosis and if these symptoms occur instruct them to discontinue KOMBIGLYZE XR and report these symptoms to their healthcare provider.
For each of the known and possible risk factors for metformin-associated lactic acidosis, recommendations to reduce the risk of and manage metformin-associated lactic acidosis are provided below:
Renal Impairment: The post-marketing metformin-associated lactic acidosis cases primarily occurred in patients with significant renal impairment. The risk of metformin accumulation and metformin-associated lactic acidosis increases with the severity of renal impairment because metformin is substantially excreted by the kidney. Clinical recommendations based upon the patient’s renal function include [].
Drug Interactions: The concomitant use of KOMBIGLYZE XR with specific drugs may increase the risk of metformin-associated lactic acidosis: those that impair renal function, result in significant hemodynamic change, interfere with acid-base balance or increase metformin accumulation []. Therefore, consider more frequent monitoring of patients.
Age 65 or Greater: The risk of metformin-associated lactic acidosis increases with the patient’s age because elderly patients have a greater likelihood of having hepatic, renal, or cardiac impairment than younger patients. Assess renal function more frequently in elderly patients [].
Radiological Studies with Contrast: Administration of intravascular iodinated contrast agents in metformin-treated patients has led to an acute decrease in renal function and the occurrence of lactic acidosis. Stop KOMBIGLYZE XR at the time of, or prior to, an iodinated contrast imaging procedure in patients with an eGFR between 30 and 60 mL/min/1.73 m; in patients with a history of hepatic impairment, alcoholism, or heart failure; or in patients who will be administered intra-arterial iodinated contrast. Re-evaluate eGFR 48 hours after the imaging procedure, and restart KOMBIGLYZE XR if renal function is stable.
Surgery and Other Procedures: Withholding of food and fluids during surgical or other procedures may increase the risk for volume depletion, hypotension and renal impairment. KOMBIGLYZE XR should be temporarily discontinued while patients have restricted food and fluid intake.
Hypoxic States: Several of the post-marketing cases of metformin-associated lactic acidosis occurred in the setting of acute congestive heart failure (particularly when accompanied by hypoperfusion and hypoxemia). Cardiovascular collapse (shock), acute myocardial infarction, sepsis, and other conditions associated with hypoxemia have been associated with lactic acidosis and may also cause prerenal azotemia. When such events occur, discontinue KOMBIGLYZE XR.
Excessive Alcohol Intake: Alcohol potentiates the effect of metformin on lactate metabolism and this may increase the risk of metformin-associated lactic acidosis. Warn patients against excessive alcohol intake while receiving KOMBIGLYZE XR.
Hepatic Impairment: Patients with hepatic impairment have developed with cases of metformin-associated lactic acidosis. This may be due to impaired lactate clearance resulting in higher lactate blood levels. Therefore, avoid use of KOMBIGLYZE XR in patients with clinical or laboratory evidence of hepatic disea
The following serious adverse reactions are described below or elsewhere in the prescribing information:
• Pancreatitis []
• Heart Failure []
• Hypoglycemia with Concomitant Use of Sulfonylurea or Insulin [ ]
• Hypersensitivity Reactions [ ]
• Severe and disabling arthralgia [ ]
• Bullous pemphigoid [ ]
Reference
This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"
While we update our database periodically, we cannot guarantee it is always updated to the latest version.
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Clonazepam Description Each single-scored tablet, for oral administration, contains 0.5 mg, 1 mg, or 2 mg Clonazepam, USP, a benzodiazepine. Each tablet also contains corn starch, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and povidone. Clonazepam tablets USP 0.5 mg contain Yellow D&C No. 10 Aluminum Lake. Clonazepam tablets USP 1 mg contain Yellow D&C No. 10 Aluminum Lake, as well as FD&C Blue No. 1 Aluminum Lake. Chemically, Clonazepam, USP is 5-(o-chlorophenyl)-1,3-dihydro-7-nitro-2H-1,4-benzodiazepin-2-one. It is a light yellow crystalline powder. It has the following structural formula: C15H10ClN3O3 M.W. 315.72Tips
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Interactions
Interactions
A total of 440 drugs (1549 brand and generic names) are known to interact with Imbruvica (ibrutinib). 228 major drug interactions (854 brand and generic names) 210 moderate drug interactions (691 brand and generic names) 2 minor drug interactions (4 brand and generic names) Show all medications in the database that may interact with Imbruvica (ibrutinib).