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Acetaminophen and Phenyltoloxamine Citrate
Overview
What is ZFLEX?
Each Tablet Contains:
Acetaminophen, 4'-hydroxyacetanilide, a slightly bitter, white odorless, crystalline powder, is a non-opiate, non-salicylate analgesic and antipyretic.
Phenyltoloxamine citrate is an antihistamine having the chemical name , -dimethyl-2-(α-phenyl--tolyloxy) ethylamine dihydrogen citrate.
Inactive ingredients: Each tablet contains povidone, microcrystalline cellulose, sodium starch glycolate and magnesium stearate.
What does ZFLEX look like?
What are the available doses of ZFLEX?
Sorry No records found.
What should I talk to my health care provider before I take ZFLEX?
Sorry No records found
How should I use ZFLEX?
For the temporary relief of minor aches and pains associated with headaches, backache, muscular aches, the menstrual and premenstrual periods, colds, the flu, toothaches, as well as for minor pain from arthritis, and to reduce fever.
Adults 12 years and over - ½ or 1 tablet every 4 hours.Maximum daily dose - 5 tablets.Children 6 to under 12 years - ½ tablet every 4 hours.Maximum daily dose - 2½ tabletsChildren under 6 years of age: consult a physician.
What interacts with ZFLEX?
This product should not be administered to patients who have previously exhibited hypersensitivity to acetaminophen or phenyltoloxamine citrate.
What are the warnings of ZFLEX?
Psychosis has been reported in sensitive individuals given anticholinergic drugs including hyoscyamine sulfate. CNS signs and symptoms include confusion, disorientation, short-term memory loss, hallucinations, dysarthria, ataxia, euphoria, anxiety, fatigue, insomnia, agitation and mannerisms, and inappropriate affect. These CNS signs and symptoms usually resolve within 12 to 48 hours after discontinuation of the drug.
Do not take this product for pain for more than 10 days (adults) or 5 days (children), and do not take for fever for more than 3 days unless directed by a physician. If pain or fever persists, if new symptoms occur, or if redness or swelling is present, consult a physician immediately because these could be signs of a serious condition. Do not give this product to children under 12 years of age for the pain of arthritis unless directed by a physician. May cause drowsiness; alcohol, sedatives and tranquilizers may increase the drowsiness effect. Avoid alcoholic beverages while taking this product. Do not take this product if you are taking sedatives or tranquilizers without first consulting your physician. Use caution when driving a motor vehicle or operating machinery.
Keep this and all drugs out of the reach of children.
What are the precautions of ZFLEX?
Sorry No Records found
What are the side effects of ZFLEX?
Sorry No records found
What should I look out for while using ZFLEX?
This product should not be administered to patients who have previously exhibited hypersensitivity to acetaminophen or phenyltoloxamine citrate.
Do not take this product for pain for more than 10 days (adults) or 5 days (children), and do not take for fever for more than 3 days unless directed by a physician. If pain or fever persists, if new symptoms occur, or if redness or swelling is present, consult a physician immediately because these could be signs of a serious condition. Do not give this product to children under 12 years of age for the pain of arthritis unless directed by a physician. May cause drowsiness; alcohol, sedatives and tranquilizers may increase the drowsiness effect. Avoid alcoholic beverages while taking this product. Do not take this product if you are taking sedatives or tranquilizers without first consulting your physician. Use caution when driving a motor vehicle or operating machinery.
Keep this and all drugs out of the reach of children.
What might happen if I take too much ZFLEX?
Following an acute overdosage, toxicity may result from phenyltoloxamine citrate or acetaminophen.
How should I store and handle ZFLEX?
Store at room temperature 15º-30ºC (59º-86ºF).Keep tightly closed.Store at room temperature 15º-30ºC (59º-86ºF).Keep tightly closed.NDC# 35501-023-01 Bottles of 100 count tablets; and samples NDC# 35501-023-02 containing 4 tablets. A red capsule shaped tablet with a score on both sides. Both sides with "ZFLEX" on the left side of the score and a blank space on the right side of the score. If tablet is broken at the score, one side will display "ZFLEX" and the other side will be blank.
Clinical Information
Chemical Structure
No Image foundClinical Pharmacology
The analgesic action of acetaminophen involves peripheral influences, but the specific mechanism is as yet undetermined. Antipyretic activity is mediated through hypothalamic heat regulating centers. Acetaminophen inhibits prostaglandin synthetase. Therapeutic doses of acetaminophen have negligible effects on the cardiovascular or respiratory systems; however, toxic doses may cause circulatory failure and rapid, shallow breathing.
Non-Clinical Toxicology
This product should not be administered to patients who have previously exhibited hypersensitivity to acetaminophen or phenyltoloxamine citrate.Do not take this product for pain for more than 10 days (adults) or 5 days (children), and do not take for fever for more than 3 days unless directed by a physician. If pain or fever persists, if new symptoms occur, or if redness or swelling is present, consult a physician immediately because these could be signs of a serious condition. Do not give this product to children under 12 years of age for the pain of arthritis unless directed by a physician. May cause drowsiness; alcohol, sedatives and tranquilizers may increase the drowsiness effect. Avoid alcoholic beverages while taking this product. Do not take this product if you are taking sedatives or tranquilizers without first consulting your physician. Use caution when driving a motor vehicle or operating machinery.
Keep this and all drugs out of the reach of children.
Additive adverse effects resulting from cholinergic blockade may occur when hyoscyamine sulfate is administered concomitantly with other antimuscarinics, amantadine, haloperidol, phenothiazines, monoamine oxidase (MAO) inhibitors, tricyclic antidepressants or some antihistamines.
Antacids may interfere with the absorption of hyoscyamine sulfate.
In patients with severe hepatic or renal disease, effects of therapy should be monitored with serial liver and/or renal function tests.
Dermatological: skin rash, pruritus.
The following adverse drug events may be borne in mind as potential effects of acetaminophen: allergic reactions, rash, thrombocytopenia, agranulocytosis.
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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