Childrens Pain Relief
Childrens Pain Relief is an FDA drug label for the active ingredient ACETAMINOPHEN manufactured by DISCOUNT DRUG MART 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: DISCOUNT DRUG MART
Product Type: HUMAN OTC DRUG
Route: ORAL
Dosage Form:
NDC: 53943-837
Application: M013
Effective: 20231208
Active Ingredients: Active ingredient (in each tablet) Acetaminophen USP 160 mg
Indications & Usage
Uses temporarily relieves minor aches and pains due to: the common cold flu headache sore 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) find right dose on chart below. If possible, use weight to dose; otherwise, use age chew before swallowing; this product will soften in mouth for ease of chewing repeat dose every 4 hours while symptoms last do not give more than 5 times in 24 hours Weight (lb) Age (yr) Dose (tablets)* * or as directed by a doctor under 24 under 2 years ask a doctor 24-35 2-3 years 1 tablet 36-47 4-5 years 1½ tablets 48-59 6-8 years 2 tablets 60-71 9-10 years 2½ tablets 72-95 11 years 3 tablets
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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