Dihydrocodeine Bitartrate, Acetaminophen and Caffeine

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Overview

What is Dihydrocodeine Bitartrate, Acetaminophen and Caffeine?

Acetaminophen, caffeine, and dihydrocodeine bitartrate tablets are supplied in tablet form for oral administration.

Each tablet contains:Acetaminophenִִִִִִִִִִִִִִִִִִִִִִִִִִִִִִִִ712.8 mgCaffeineִִִִִִִִִִִִִִִִִִִִִִִִִִִִִִִִִִִִִִִִִִִִִ60 mgDihydrocodeine* bitartrateִִִִִִִִִִִִִִִִִִִִִִ32 mg*Warning: May be habit forming

Acetaminophen (4'-hydroxyacetanilide), a slightly bitter, white, odorless, crystalline powder, is a non-opiate, non-salicylate analgesic and antipyretic.

It has the following structural formula:

Caffeine (1,3,7-trimethylxanthine), a bitter, white crystalline powder, is a central nervous system stimulant. It has the following structural formula:

Dihydrocodeine Bitartrate (4,5a-epoxy-3-methoxy-17-methylmDihydrocodeine Bitartrate (4,5a-epoxy-3-methoxy-17-methylmDihydrocodeine Bitartrate (4,5a-epoxy-3-methoxy-17-methylmDihydrocodeine Bitartrate (4,5a-epoxy-3-methoxy-17-methylmorphinan-6a-ol (+)-tartrate), an odorless, fine white powder is an opioid analgesic. It has the following structural formula:

In addition, each tablet also contains the following inactive ingredients: crospovidone, magnesium stearate, microcrystalline cellulose, povidone, pregelatinized starch, stearic acid.

What does Dihydrocodeine Bitartrate, Acetaminophen and Caffeine look like?

What are the available doses of Dihydrocodeine Bitartrate, Acetaminophen and Caffeine?

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What should I talk to my health care provider before I take Dihydrocodeine Bitartrate, Acetaminophen and Caffeine?

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How should I use Dihydrocodeine Bitartrate, Acetaminophen and Caffeine?

Acetaminophen, caffeine, and dihydrocodeine bitartrate tablets are indicated for the relief of moderate to moderately severe pain.

The usual adult dosage is one (1) Acetaminophen, caffeine, and dihydrocodeine bitartrate tablets orally every four (4) hours, as needed. Dosage should be adjusted according to the severity of the pain and the response of the patient. No more than one (1) tablet should be taken in a 4-hour period. No more than five (5) doses, or five (5) tablets should be taken in a 24-hour period.

What interacts with Dihydrocodeine Bitartrate, Acetaminophen and Caffeine?

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What are the warnings of Dihydrocodeine Bitartrate, Acetaminophen and Caffeine?

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What are the precautions of Dihydrocodeine Bitartrate, Acetaminophen and Caffeine?

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What are the side effects of Dihydrocodeine Bitartrate, Acetaminophen and Caffeine?

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What should I look out for while using Dihydrocodeine Bitartrate, Acetaminophen and Caffeine?

This combination product is contraindicated in persons with hypersensitivity to dihydrocodeine, codeine, acetaminophen, caffeine, or any of the inactive components listed above, or any situation where opioids are contraindicated including significant respiratory depression (in unmonitored settings or in the absence of resuscitative equipment), acute or severe bronchial asthma or hypercapnia, and paralytic ileus.

What might happen if I take too much Dihydrocodeine Bitartrate, Acetaminophen and Caffeine?

Following an acute overdosage with Acetaminophen, caffeine, and dihydrocodeine bitartrate tablets, toxicity may result from the dihydrocodeine, acetaminophen, or, less likely, caffeine component. An overdose is a potentially lethal polydrug overdose situation, and consultation with a regional poison control center is recommended. A listing of the poison control centers can be found in standard references such as the Physician's Desk Reference®.

Signs and Symptoms and Laboratory Findings:

Toxicity from dihydrocodeine is typical of opioids and includes pinpoint pupils, respiratory depression, and loss of consciousness. Convulsions, cardiovascular collapse, and death may occur. A single case of acute rhabdomyolysis associated with an overdose of dihydrocodeine has been reported. With acetaminophen, dose-dependent potentially fatal hepatic necrosis is the most serious adverse effect. Renal tubular necrosis, hypoglycemic coma, and thrombocytopenia may occur. Early symptoms of hepatotoxicity include nausea, vomiting, diaphoresis, and general malaise. Clinical and laboratory evidence of hepatic toxicity may not be apparent until 48 to 72 hours after ingestion. Acute caffeine poisoning may cause insomnia, restlessness, tremor, delirium, tachycardia, extrasystoles, and seizures.

Because overdose information on this combination product is limited, it is unclear which of the signs and symptoms of toxicity would manifest in any particular overdose situation.

Treatment:

Immediate treatment of an overdosage of Acetaminophen, caffeine, and dihydrocodeine bitartrate tablets includes support of cardiorespiratory function and measures to reduce drug absorption. Vomiting should be induced with syrup of ipecac, if the patient is alert and has adequate laryngeal reflexes. Oral activated charcoal should follow. The first dose of charcoal should be accompanied by an appropriate cathartic. Gastric lavage may be necessary. Hypotension is usually hypovolemic and should be treated with fluids. Endotracheal intubation and artificial respiration may be necessary. Peritoneal or hemodialysis may be necessary. If hypoprothrombinemia occurs, Vitamin K should be administered.

A pure opioid antagonist, such as naloxone or nalmefene, is a specific antidote against respiratory depression which results from opioid overdose. Opioid antagonists should not be given in the absence of clinically significant respiratory or circulatory depression secondary to opioid overdose. They should be administered cautiously to persons who are known, or suspected to be, physically dependent on any opioid agonist including Acetaminophen, caffeine, and dihydrocodeine bitartrate tablets. In such cases, an abrupt or complete reversal of opioid effects may precipitate an acute abstinence syndrome. The prescribing information for the specific opioid antagonist should be consulted for details of their proper use.

In adults and adolescents, regardless of the quantity of acetaminophen reported to have been ingested, acetylcysteine should be administered immediately if 24 hours or less have elapsed from the reported time of ingestion. It is not advisable to await the plasma concentration determination of acetaminophen before administering acetylcysteine. Serum liver enzyme levels should be measured. Therapy in children involves a similar treatment scheme; however, a regional Poison Control Center should be contacted. No specific antidote is available for caffeine. In addition to the supportive measures above, administration of demulcents such as aluminum hydroxide gel may diminish gastrointestinal irritation. Seizures may be treated with intravenous diazepam or a barbiturate.

How should I store and handle Dihydrocodeine Bitartrate, Acetaminophen and Caffeine?

LANTUS should not be stored in the freezer and should not be allowed to freeze. Discard LANTUS if it has been frozen.Unopened Vial/Cartridge system/SoloStar disposable insulin device:Unopened LANTUS vials, cartridge systems and SoloStar device should be stored in a refrigerator, 36°F – 46°F (2°C – 8°C). Discard after the expiration date. Open (In-Use) Vial:Vials must be discarded 28 days after being opened. If refrigeration is not possible, the open vial can be kept unrefrigerated for up to 28 days away from direct heat and light, as long as the temperature is not greater than 86°F (30°C). Open (In-Use) Cartridge system:The opened (in-use) cartridge system in OptiClik should NOT be refrigerated but should be kept at room temperature (below 86°F [30°C]) away from direct heat and light. The opened (in-use) cartridge system in OptiClik must be discarded 28 days after being opened. Do not store OptiClik , with or without cartridge system, in a refrigerator at any time.Open (In-Use) SoloStar disposable insulin device:The opened (in-use) SoloStar should NOT be refrigerated but should be kept at room temperature (below 86°F [30°C]) away from direct heat and light. The opened (in-use) SoloStar device must be discarded 28 days after being opened.These storage conditions are summarized in the following table:ArrayLANTUS should not be stored in the freezer and should not be allowed to freeze. Discard LANTUS if it has been frozen.Unopened Vial/Cartridge system/SoloStar disposable insulin device:Unopened LANTUS vials, cartridge systems and SoloStar device should be stored in a refrigerator, 36°F – 46°F (2°C – 8°C). Discard after the expiration date. Open (In-Use) Vial:Vials must be discarded 28 days after being opened. If refrigeration is not possible, the open vial can be kept unrefrigerated for up to 28 days away from direct heat and light, as long as the temperature is not greater than 86°F (30°C). Open (In-Use) Cartridge system:The opened (in-use) cartridge system in OptiClik should NOT be refrigerated but should be kept at room temperature (below 86°F [30°C]) away from direct heat and light. The opened (in-use) cartridge system in OptiClik must be discarded 28 days after being opened. Do not store OptiClik , with or without cartridge system, in a refrigerator at any time.Open (In-Use) SoloStar disposable insulin device:The opened (in-use) SoloStar should NOT be refrigerated but should be kept at room temperature (below 86°F [30°C]) away from direct heat and light. The opened (in-use) SoloStar device must be discarded 28 days after being opened.These storage conditions are summarized in the following table:ArrayLANTUS should not be stored in the freezer and should not be allowed to freeze. Discard LANTUS if it has been frozen.Unopened Vial/Cartridge system/SoloStar disposable insulin device:Unopened LANTUS vials, cartridge systems and SoloStar device should be stored in a refrigerator, 36°F – 46°F (2°C – 8°C). Discard after the expiration date. Open (In-Use) Vial:Vials must be discarded 28 days after being opened. If refrigeration is not possible, the open vial can be kept unrefrigerated for up to 28 days away from direct heat and light, as long as the temperature is not greater than 86°F (30°C). Open (In-Use) Cartridge system:The opened (in-use) cartridge system in OptiClik should NOT be refrigerated but should be kept at room temperature (below 86°F [30°C]) away from direct heat and light. The opened (in-use) cartridge system in OptiClik must be discarded 28 days after being opened. Do not store OptiClik , with or without cartridge system, in a refrigerator at any time.Open (In-Use) SoloStar disposable insulin device:The opened (in-use) SoloStar should NOT be refrigerated but should be kept at room temperature (below 86°F [30°C]) away from direct heat and light. The opened (in-use) SoloStar device must be discarded 28 days after being opened.These storage conditions are summarized in the following table:ArrayLANTUS should not be stored in the freezer and should not be allowed to freeze. Discard LANTUS if it has been frozen.Unopened Vial/Cartridge system/SoloStar disposable insulin device:Unopened LANTUS vials, cartridge systems and SoloStar device should be stored in a refrigerator, 36°F – 46°F (2°C – 8°C). Discard after the expiration date. Open (In-Use) Vial:Vials must be discarded 28 days after being opened. If refrigeration is not possible, the open vial can be kept unrefrigerated for up to 28 days away from direct heat and light, as long as the temperature is not greater than 86°F (30°C). Open (In-Use) Cartridge system:The opened (in-use) cartridge system in OptiClik should NOT be refrigerated but should be kept at room temperature (below 86°F [30°C]) away from direct heat and light. The opened (in-use) cartridge system in OptiClik must be discarded 28 days after being opened. Do not store OptiClik , with or without cartridge system, in a refrigerator at any time.Open (In-Use) SoloStar disposable insulin device:The opened (in-use) SoloStar should NOT be refrigerated but should be kept at room temperature (below 86°F [30°C]) away from direct heat and light. The opened (in-use) SoloStar device must be discarded 28 days after being opened.These storage conditions are summarized in the following table:ArrayLANTUS should not be stored in the freezer and should not be allowed to freeze. Discard LANTUS if it has been frozen.Unopened Vial/Cartridge system/SoloStar disposable insulin device:Unopened LANTUS vials, cartridge systems and SoloStar device should be stored in a refrigerator, 36°F – 46°F (2°C – 8°C). Discard after the expiration date. Open (In-Use) Vial:Vials must be discarded 28 days after being opened. If refrigeration is not possible, the open vial can be kept unrefrigerated for up to 28 days away from direct heat and light, as long as the temperature is not greater than 86°F (30°C). Open (In-Use) Cartridge system:The opened (in-use) cartridge system in OptiClik should NOT be refrigerated but should be kept at room temperature (below 86°F [30°C]) away from direct heat and light. The opened (in-use) cartridge system in OptiClik must be discarded 28 days after being opened. Do not store OptiClik , with or without cartridge system, in a refrigerator at any time.Open (In-Use) SoloStar disposable insulin device:The opened (in-use) SoloStar should NOT be refrigerated but should be kept at room temperature (below 86°F [30°C]) away from direct heat and light. The opened (in-use) SoloStar device must be discarded 28 days after being opened.These storage conditions are summarized in the following table:ArrayLANTUS should not be stored in the freezer and should not be allowed to freeze. Discard LANTUS if it has been frozen.Unopened Vial/Cartridge system/SoloStar disposable insulin device:Unopened LANTUS vials, cartridge systems and SoloStar device should be stored in a refrigerator, 36°F – 46°F (2°C – 8°C). Discard after the expiration date. Open (In-Use) Vial:Vials must be discarded 28 days after being opened. If refrigeration is not possible, the open vial can be kept unrefrigerated for up to 28 days away from direct heat and light, as long as the temperature is not greater than 86°F (30°C). Open (In-Use) Cartridge system:The opened (in-use) cartridge system in OptiClik should NOT be refrigerated but should be kept at room temperature (below 86°F [30°C]) away from direct heat and light. The opened (in-use) cartridge system in OptiClik must be discarded 28 days after being opened. Do not store OptiClik , with or without cartridge system, in a refrigerator at any time.Open (In-Use) SoloStar disposable insulin device:The opened (in-use) SoloStar should NOT be refrigerated but should be kept at room temperature (below 86°F [30°C]) away from direct heat and light. The opened (in-use) SoloStar device must be discarded 28 days after being opened.These storage conditions are summarized in the following table:ArrayLANTUS should not be stored in the freezer and should not be allowed to freeze. Discard LANTUS if it has been frozen.Unopened Vial/Cartridge system/SoloStar disposable insulin device:Unopened LANTUS vials, cartridge systems and SoloStar device should be stored in a refrigerator, 36°F – 46°F (2°C – 8°C). Discard after the expiration date. Open (In-Use) Vial:Vials must be discarded 28 days after being opened. If refrigeration is not possible, the open vial can be kept unrefrigerated for up to 28 days away from direct heat and light, as long as the temperature is not greater than 86°F (30°C). Open (In-Use) Cartridge system:The opened (in-use) cartridge system in OptiClik should NOT be refrigerated but should be kept at room temperature (below 86°F [30°C]) away from direct heat and light. The opened (in-use) cartridge system in OptiClik must be discarded 28 days after being opened. Do not store OptiClik , with or without cartridge system, in a refrigerator at any time.Open (In-Use) SoloStar disposable insulin device:The opened (in-use) SoloStar should NOT be refrigerated but should be kept at room temperature (below 86°F [30°C]) away from direct heat and light. The opened (in-use) SoloStar device must be discarded 28 days after being opened.These storage conditions are summarized in the following table:ArrayLANTUS should not be stored in the freezer and should not be allowed to freeze. Discard LANTUS if it has been frozen.Unopened Vial/Cartridge system/SoloStar disposable insulin device:Unopened LANTUS vials, cartridge systems and SoloStar device should be stored in a refrigerator, 36°F – 46°F (2°C – 8°C). Discard after the expiration date. Open (In-Use) Vial:Vials must be discarded 28 days after being opened. If refrigeration is not possible, the open vial can be kept unrefrigerated for up to 28 days away from direct heat and light, as long as the temperature is not greater than 86°F (30°C). Open (In-Use) Cartridge system:The opened (in-use) cartridge system in OptiClik should NOT be refrigerated but should be kept at room temperature (below 86°F [30°C]) away from direct heat and light. The opened (in-use) cartridge system in OptiClik must be discarded 28 days after being opened. Do not store OptiClik , with or without cartridge system, in a refrigerator at any time.Open (In-Use) SoloStar disposable insulin device:The opened (in-use) SoloStar should NOT be refrigerated but should be kept at room temperature (below 86°F [30°C]) away from direct heat and light. The opened (in-use) SoloStar device must be discarded 28 days after being opened.These storage conditions are summarized in the following table:ArrayLANTUS should not be stored in the freezer and should not be allowed to freeze. Discard LANTUS if it has been frozen.Unopened Vial/Cartridge system/SoloStar disposable insulin device:Unopened LANTUS vials, cartridge systems and SoloStar device should be stored in a refrigerator, 36°F – 46°F (2°C – 8°C). Discard after the expiration date. Open (In-Use) Vial:Vials must be discarded 28 days after being opened. If refrigeration is not possible, the open vial can be kept unrefrigerated for up to 28 days away from direct heat and light, as long as the temperature is not greater than 86°F (30°C). Open (In-Use) Cartridge system:The opened (in-use) cartridge system in OptiClik should NOT be refrigerated but should be kept at room temperature (below 86°F [30°C]) away from direct heat and light. The opened (in-use) cartridge system in OptiClik must be discarded 28 days after being opened. Do not store OptiClik , with or without cartridge system, in a refrigerator at any time.Open (In-Use) SoloStar disposable insulin device:The opened (in-use) SoloStar should NOT be refrigerated but should be kept at room temperature (below 86°F [30°C]) away from direct heat and light. The opened (in-use) SoloStar device must be discarded 28 days after being opened.These storage conditions are summarized in the following table:ArrayLANTUS should not be stored in the freezer and should not be allowed to freeze. Discard LANTUS if it has been frozen.Unopened Vial/Cartridge system/SoloStar disposable insulin device:Unopened LANTUS vials, cartridge systems and SoloStar device should be stored in a refrigerator, 36°F – 46°F (2°C – 8°C). Discard after the expiration date. Open (In-Use) Vial:Vials must be discarded 28 days after being opened. If refrigeration is not possible, the open vial can be kept unrefrigerated for up to 28 days away from direct heat and light, as long as the temperature is not greater than 86°F (30°C). Open (In-Use) Cartridge system:The opened (in-use) cartridge system in OptiClik should NOT be refrigerated but should be kept at room temperature (below 86°F [30°C]) away from direct heat and light. The opened (in-use) cartridge system in OptiClik must be discarded 28 days after being opened. Do not store OptiClik , with or without cartridge system, in a refrigerator at any time.Open (In-Use) SoloStar disposable insulin device:The opened (in-use) SoloStar should NOT be refrigerated but should be kept at room temperature (below 86°F [30°C]) away from direct heat and light. The opened (in-use) SoloStar device must be discarded 28 days after being opened.These storage conditions are summarized in the following table:ArrayLANTUS should not be stored in the freezer and should not be allowed to freeze. Discard LANTUS if it has been frozen.Unopened Vial/Cartridge system/SoloStar disposable insulin device:Unopened LANTUS vials, cartridge systems and SoloStar device should be stored in a refrigerator, 36°F – 46°F (2°C – 8°C). Discard after the expiration date. Open (In-Use) Vial:Vials must be discarded 28 days after being opened. If refrigeration is not possible, the open vial can be kept unrefrigerated for up to 28 days away from direct heat and light, as long as the temperature is not greater than 86°F (30°C). Open (In-Use) Cartridge system:The opened (in-use) cartridge system in OptiClik should NOT be refrigerated but should be kept at room temperature (below 86°F [30°C]) away from direct heat and light. The opened (in-use) cartridge system in OptiClik must be discarded 28 days after being opened. Do not store OptiClik , with or without cartridge system, in a refrigerator at any time.Open (In-Use) SoloStar disposable insulin device:The opened (in-use) SoloStar should NOT be refrigerated but should be kept at room temperature (below 86°F [30°C]) away from direct heat and light. The opened (in-use) SoloStar device must be discarded 28 days after being opened.These storage conditions are summarized in the following table:ArrayAcetaminophen, caffeine, and dihydrocodeine bitartrate tablets, containing acetaminophen 712.8 mg, caffeine 60 mg and dihydrocodeine* bitartrate 32 mg (*Warning: May be habit-forming). Tablets are white, oval-shaped single scored and are debossed “Boca” on one side and “611” on the other side; are supplied in Store at 20°C to 25°C (68°F to 77°F). [see USP Controlled Room Temperature]. Protect from moisture.Dispense in a tight, light-resistant container with a child-resistant closure.Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.Rx OnlyManufactured for:Boca Pharmacal, Inc.Coral Springs, FL 33065 www.bocapharmacal.comRev. 06/09Physician’s Desk Reference® is the registered trademark of Thomson Healthcare, Inc. Relabeling and Repackaging by:Acetaminophen, caffeine, and dihydrocodeine bitartrate tablets, containing acetaminophen 712.8 mg, caffeine 60 mg and dihydrocodeine* bitartrate 32 mg (*Warning: May be habit-forming). Tablets are white, oval-shaped single scored and are debossed “Boca” on one side and “611” on the other side; are supplied in Store at 20°C to 25°C (68°F to 77°F). [see USP Controlled Room Temperature]. Protect from moisture.Dispense in a tight, light-resistant container with a child-resistant closure.Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.Rx OnlyManufactured for:Boca Pharmacal, Inc.Coral Springs, FL 33065 www.bocapharmacal.comRev. 06/09Physician’s Desk Reference® is the registered trademark of Thomson Healthcare, Inc. Relabeling and Repackaging by:Acetaminophen, caffeine, and dihydrocodeine bitartrate tablets, containing acetaminophen 712.8 mg, caffeine 60 mg and dihydrocodeine* bitartrate 32 mg (*Warning: May be habit-forming). Tablets are white, oval-shaped single scored and are debossed “Boca” on one side and “611” on the other side; are supplied in Store at 20°C to 25°C (68°F to 77°F). [see USP Controlled Room Temperature]. Protect from moisture.Dispense in a tight, light-resistant container with a child-resistant closure.Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.Rx OnlyManufactured for:Boca Pharmacal, Inc.Coral Springs, FL 33065 www.bocapharmacal.comRev. 06/09Physician’s Desk Reference® is the registered trademark of Thomson Healthcare, Inc. Relabeling and Repackaging by:Acetaminophen, caffeine, and dihydrocodeine bitartrate tablets, containing acetaminophen 712.8 mg, caffeine 60 mg and dihydrocodeine* bitartrate 32 mg (*Warning: May be habit-forming). Tablets are white, oval-shaped single scored and are debossed “Boca” on one side and “611” on the other side; are supplied in Store at 20°C to 25°C (68°F to 77°F). [see USP Controlled Room Temperature]. Protect from moisture.Dispense in a tight, light-resistant container with a child-resistant closure.Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.Rx OnlyManufactured for:Boca Pharmacal, Inc.Coral Springs, FL 33065 www.bocapharmacal.comRev. 06/09Physician’s Desk Reference® is the registered trademark of Thomson Healthcare, Inc. Relabeling and Repackaging by:Acetaminophen, caffeine, and dihydrocodeine bitartrate tablets, containing acetaminophen 712.8 mg, caffeine 60 mg and dihydrocodeine* bitartrate 32 mg (*Warning: May be habit-forming). Tablets are white, oval-shaped single scored and are debossed “Boca” on one side and “611” on the other side; are supplied in Store at 20°C to 25°C (68°F to 77°F). [see USP Controlled Room Temperature]. Protect from moisture.Dispense in a tight, light-resistant container with a child-resistant closure.Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.Rx OnlyManufactured for:Boca Pharmacal, Inc.Coral Springs, FL 33065 www.bocapharmacal.comRev. 06/09Physician’s Desk Reference® is the registered trademark of Thomson Healthcare, Inc. Relabeling and Repackaging by:Acetaminophen, caffeine, and dihydrocodeine bitartrate tablets, containing acetaminophen 712.8 mg, caffeine 60 mg and dihydrocodeine* bitartrate 32 mg (*Warning: May be habit-forming). Tablets are white, oval-shaped single scored and are debossed “Boca” on one side and “611” on the other side; are supplied in Store at 20°C to 25°C (68°F to 77°F). [see USP Controlled Room Temperature]. Protect from moisture.Dispense in a tight, light-resistant container with a child-resistant closure.Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.Rx OnlyManufactured for:Boca Pharmacal, Inc.Coral Springs, FL 33065 www.bocapharmacal.comRev. 06/09Physician’s Desk Reference® is the registered trademark of Thomson Healthcare, Inc. Relabeling and Repackaging by:Acetaminophen, caffeine, and dihydrocodeine bitartrate tablets, containing acetaminophen 712.8 mg, caffeine 60 mg and dihydrocodeine* bitartrate 32 mg (*Warning: May be habit-forming). Tablets are white, oval-shaped single scored and are debossed “Boca” on one side and “611” on the other side; are supplied in Store at 20°C to 25°C (68°F to 77°F). [see USP Controlled Room Temperature]. Protect from moisture.Dispense in a tight, light-resistant container with a child-resistant closure.Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.Rx OnlyManufactured for:Boca Pharmacal, Inc.Coral Springs, FL 33065 www.bocapharmacal.comRev. 06/09Physician’s Desk Reference® is the registered trademark of Thomson Healthcare, Inc. Relabeling and Repackaging by:Acetaminophen, caffeine, and dihydrocodeine bitartrate tablets, containing acetaminophen 712.8 mg, caffeine 60 mg and dihydrocodeine* bitartrate 32 mg (*Warning: May be habit-forming). Tablets are white, oval-shaped single scored and are debossed “Boca” on one side and “611” on the other side; are supplied in Store at 20°C to 25°C (68°F to 77°F). [see USP Controlled Room Temperature]. Protect from moisture.Dispense in a tight, light-resistant container with a child-resistant closure.Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.Rx OnlyManufactured for:Boca Pharmacal, Inc.Coral Springs, FL 33065 www.bocapharmacal.comRev. 06/09Physician’s Desk Reference® is the registered trademark of Thomson Healthcare, Inc. Relabeling and Repackaging by:Acetaminophen, caffeine, and dihydrocodeine bitartrate tablets, containing acetaminophen 712.8 mg, caffeine 60 mg and dihydrocodeine* bitartrate 32 mg (*Warning: May be habit-forming). Tablets are white, oval-shaped single scored and are debossed “Boca” on one side and “611” on the other side; are supplied in Store at 20°C to 25°C (68°F to 77°F). [see USP Controlled Room Temperature]. Protect from moisture.Dispense in a tight, light-resistant container with a child-resistant closure.Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.Rx OnlyManufactured for:Boca Pharmacal, Inc.Coral Springs, FL 33065 www.bocapharmacal.comRev. 06/09Physician’s Desk Reference® is the registered trademark of Thomson Healthcare, Inc. Relabeling and Repackaging by:

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Clinical Information

Chemical Structure

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Clinical Pharmacology

Acetaminophen, caffeine, and dihydrocodeine bitartrate tablets contain dihydrocodeine which is a semisynthetic narcotic analgesic related to codeine, with multiple actions qualitatively similar to those of codeine; the most prominent of these involve the central nervous system and organs with smooth muscle components. The principal action of therapeutic value is analgesia.

This combination product also contains acetaminophen, a non-opiate, non-salicylate analgesic and antipyretic. This combination product contains caffeine as an analgesic adjuvant. Caffeine is also a central nervous system and cardiovascular stimulant.

Non-Clinical Toxicology

This combination product is contraindicated in persons with hypersensitivity to dihydrocodeine, codeine, acetaminophen, caffeine, or any of the inactive components listed above, or any situation where opioids are contraindicated including significant respiratory depression (in unmonitored settings or in the absence of resuscitative equipment), acute or severe bronchial asthma or hypercapnia, and paralytic ileus.

(see also

Selection of patients for treatment with Acetaminophen, caffeine, and dihydrocodeine bitartrate tablets should be governed by the same principles that apply to the use of similar opioid/non-opioid fixed combination analgesics. As with any such opioid analgesic, the dosing regimen should be adjusted for each patient (see ). This combination product should be used with caution in elderly or debilitated patients or those with any of the following conditions: acute alcoholism; adrenocortical insufficiency (e.g., Addison's disease); asthma; central nervous system depression or coma; chronic obstructive pulmonary disease; decreased respiratory reserve (including emphysema, severe obesity, cor pulmonale, or kyphoscoliosis); delirium tremens; head injury; hypotension; increased intracranial pressure; myxedema or hypothyroidism; prostatic hypertrophy or urethral stricture; and toxic psychosis. The benefits and risks of using opioids in patients taking monoamine oxidase inhibitors and in those with a history of drug abuse should be carefully considered. The administration of an analgesic containing an opioid may obscure the diagnosis or clinical course in patients with acute abdominal conditions. This combination product may aggravate convulsions in patients with convulsive disorders and, like all opioids, may induce or aggravate seizures in some clinical settings. Acetaminophen is relatively non-toxic at therapeutic doses, but should be used with caution in patients with severe renal or hepatic disease. Care should be observed when using large doses of acetaminophen in malnourished patients or those with a history of chronic alcohol abuse because they may be more susceptible to hepatic damage similar to that observed with toxic overdosage.

Caffeine in high doses may produce central nervous system and cardiovascular stimulation and gastrointestinal irritation.

Dihydrocodeine:

The most frequently observed adverse reactions include light-headedness, dizziness, drowsiness, headache, fatigue, sedation, sweating, nausea, vomiting, constipation, pruritus, and skin reactions. With the exception of constipation, tolerance develops to most of these effects. Other reactions that have been observed with dihydrocodeine or other opioids include respiratory depression, orthostatic hypotension, cough suppression, confusion, diarrhea, miosis, abdominal pain, dry mouth, indigestion, anorexia, spasm of biliary tract, and urinary retention. Physical and psychological dependence are possibilities. Hypersensitivity reactions (including anaphylactoid reactions), hallucinations, vivid dreams, granulomatous interstitial nephritis, severe narcosis and acute renal failure have been reported rarely during dihydrocodeine administration.

Acetaminophen:

Acetaminophen in therapeutic doses rarely causes adverse reactions.

The most serious adverse reaction is hepatoxicity from overdosage (see ). Thrombocytopenia, leukopenia, pancytopenia, neutropenia, thrombocytopenic purpura, and agranulocytosis have been reported in patients receiving acetaminophen or p-aminophenol derivatives. Hypersensitivity reactions including urticarial or erythematous skin reactions, laryngeal edema, angioedema, or anaphylactoid reactions are rare.

Caffeine:

Adverse reactions associated with caffeine use include anxiety, anxiety neurosis, excitement, headaches, insomnia, irritability, lightheadedness, restlessness, tenseness, tremor, extrasystoles, palpitations, tachycardia, diarrhea, nausea, stomach pain, vomiting, diuresis, urticarcia, scintillating scotoma, and tinnitus.

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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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