Aurophen Extra Strength for Adults
Aurophen Extra Strength for Adults is an FDA drug label for the active ingredient ACETAMINOPHEN manufactured by Aurohealth LLC 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 20231129.
Generic: ACETAMINOPHEN
Manufacturer: Aurohealth LLC
Product Type: HUMAN OTC DRUG
Route: ORAL
Dosage Form:
NDC: 58602-755
Application: M013
Effective: 20231129
Active Ingredients: Drug Facts Active ingredient (in each caplet) Acetaminophen USP 500 mg
Indications & Usage
Uses temporarily relieves minor aches and pains due to: the common cold headache backache minor pain of arthritis toothache muscular aches premenstrual and menstrual cramps temporarily reduces fever
Dosage & Administration
Directions do not take more than directed (see overdose warning) adults and 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 use 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. 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 Allergy alert: acetaminophen may cause severe skin reactions. Symptoms may include: skin reddening blisters rash If a skin reaction occurs, stop use and seek medical help right away.
Adverse Reactions
Not available.
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