Acetaminophen
Acetaminophen is an FDA drug label for the active ingredient ACETAMINOPHEN manufactured by WALGREEN CO. 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 20231208.
Generic: ACETAMINOPHEN
Manufacturer: WALGREEN CO.
Product Type: HUMAN OTC DRUG
Route: ORAL
Dosage Form:
NDC: 0363-9605
Application: M013
Effective: 20231208
Active Ingredients: Drug Facts Active ingredient (in each chewable tablet) Acetaminophen USP 160 mg
Indications & Usage
Uses temporarily relieves minor aches and pains due to: the common cold flu headache soar throat toothache temporarily reduces fever
Dosage & Administration
Directions this product does not contain directions or complete warnings for adult use. do not give more than directed (see overdose warning) chew or crush tablets completely before swallowing; do not swallow tablets whole find right dose on chart below. If possible, use weight to dose; otherwise, use age repeat dose every 4 hours while symptoms last do not give more than 5 times in 24 hours Weight (lb) Age (yr) Dose (tablets)* under 24 under 2 years ask a doctor 24 to 35 lbs 2 to 3 years 1 tablet 36 to 47 lbs 4 to 5 years 1½ tablets 48 to 59 lbs 6 to 8 years 2 tablets 60 to 71 lbs 9 to 10 years 2½ tablets 72 to 95 lbs 11 years 3 tablets * or as directed by a doctor
Contraindications
Not available.
Warnings
Warnings Liver warning: This product contains acetaminophen. Severe liver damage may occur if your child takes more than 5 doses in 24 hours, which is the maximum daily amount with other drugs containing acetaminophen 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. Sore throat warning: if sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly.
Adverse Reactions
Not available.
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