APAP

APAP is an FDA drug label for the active ingredient ACETAMINOPHEN manufactured by Advance Pharmaceutical Inc. administered by ORAL. This page reproduces the FDA-approved indications and usage, dosage, contraindications, warnings, and adverse reactions exactly as published in the drug label. Data source: openFDA (U.S. FDA), label effective 20171222.

Generic: ACETAMINOPHEN

Manufacturer: Advance Pharmaceutical Inc.

Product Type: HUMAN OTC DRUG

Route: ORAL

Dosage Form:

NDC: 17714-014

Application: part343

Effective: 20171222

Active Ingredients: Active Ingredient (in each caplet) Acetaminophen 500 mg

Indications & Usage

Uses temporarily relieves minor aches and pains due to: headache muscular aches backache minor pain of arthritis the common cold toothache premenstrual and menstrual cramps temporarily reduces fever

Dosage & Administration

Directions Do not take more than directed (see over dose warning) adults & children 12 years and over : take 2 caplets every 6 hours while symptoms last do not take more than 6 caplets in 24 hours, unless directed by a doctor do not take for more than 10 days unless directed by a doctor children under 12 years : ask a doctor

Contraindications

Not available.

Warnings

Warnings Liver warning: this product contains acetaminophen. The maximum daily dose of this product is 6 caplets (3,000 mg) in 24 hours. Severe liver damage may occur if you take more than 4,000 mg of acetaminophen in 24 hours with other drugs containing acetaminophen 3 or more alcoholic drinks every day while using this product do not use with any other drug containing acetaminophen (prescription or non prescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist. If you are allergic to acetaminophen or any of the inactive ingredients in this product Ask a doctor before use if the you have liver disease Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin Stop use and ask a doctor if pain gets worse or lasts more than 10 days fever gets worse or lasts more than 3 days redness or swelling is present new symptoms occur these could be signs of a serious condition. If pregnant or breast-feeding, ask a health professional before use.

Adverse Reactions

Not available.

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