Childrens Pain and Fever, Grape flavor

Childrens Pain and Fever, Grape flavor is an FDA drug label for the active ingredient ACETAMINOPHEN manufactured by Walgreen 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 20231229.

Generic: ACETAMINOPHEN

Manufacturer: Walgreen Company

Product Type: HUMAN OTC DRUG

Route: ORAL

Dosage Form:

NDC: 0363-0323

Application: M013

Effective: 20231229

Active Ingredients: Active ingredient (in each 5 mL = 1 teaspoonful) Acetaminophen 160 mg

Indications & Usage

Uses temporarily ■ reduces fever ■ relieves minor aches and pains due to: ■ the common cold ■ flu ■ headache ■ sore throat ■ toothache

Dosage & Administration

Directions ■ this product does not contain directions or complete warnings for adult use. ■ shake well before using ■ mL = milliliter; tsp = teaspoonful ■ find the right dose on the chart below. If possible, use weight to dose, otherwise, use age. ■ if needed, repeat dose every 4 hours while symptoms last ■ do not give more than 5 times in 24 hours ■ do not give for more than 5 days unless directed by a doctor. Weight (lb) Age (yr) Dose (mL or tsp)* under 24 under 2 years ask a doctor 24-35 2 - 3 years 5 mL (1 tsp) 36-47 4 - 5 years 7.5 mL (1 1/2 tsp) 48-59 6 - 8 years 10 mL (2 tsp) 60-71 9 - 10 years 12.5. mL (2 1/2 tsp) 72-95 11 years 15 mL (3 tsp) * or as directed by a doctor Attention: use only enclosed dosing cup specifically designed for use with this product. Do not use any other dosing device.

Contraindications

Not available.

Warnings

Warnings Liver warning This product contains acetaminophen. Severe liver damage may occur nyour 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 ever, headache, rash. nausea or vomiting, consult a doctor promptly.

Adverse Reactions

Not available.

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