Acetaminophen Extra Strength
Acetaminophen Extra Strength is an FDA drug label for the active ingredient ACETAMINOPHEN manufactured by KROGER COMPANY 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 20231206.
Generic: ACETAMINOPHEN
Manufacturer: KROGER COMPANY
Product Type: HUMAN OTC DRUG
Route: ORAL
Dosage Form:
NDC: 30142-165
Application: M013
Effective: 20231206
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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