Pain Relief Childrens

ACETAMINOPHEN ORAL HUMAN OTC DRUG

Pain Relief Childrens is an FDA drug label for the active ingredient ACETAMINOPHEN manufactured by Dolgencorp, Inc. (DOLLAR GENERAL & REXALL) 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 name
ACETAMINOPHEN
Manufacturer
Dolgencorp, Inc. (DOLLAR GENERAL & REXALL)
Product type
HUMAN OTC DRUG
Route
ORAL
Dosage form
N/A
NDC
55910-282
Application
M013
Label effective
20231206

Active ingredients

Active ingredient (in each 5 mL) Acetaminophen 160 mg

Indications & Usage

Uses temporarily reduces fever temporarily 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 do not take more than directed (see overdose warning) shake well before using mL= milliliter use only the enclosed dosing cup designed for use with this product. Do not use any other dosing device. if needed, repeat dose every 4 hours while symptoms last do not give more than 5 times in 24 hours do not give more than 5 days unless directed by a doctor find the right dose on chart below. If possible, use weight to dose, use age. Weight (lb) Age (year) Dose (mL) under 24 under 2 ask a doctor 24-35 2-3 5 mL 36-47 4-5 7.5 ml 48-59 6-8 10 mL 60-71 9-10 12.5 mL 72-95 11 15 mL

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. Do not use with any other drug containing acetaminophen (prescription or non-prescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist. if your child is allergic to acetaminophen or any of the inactive ingredients in this product Ask a doctor before use if your child has liver disease. Ask a doctor or pharmacist before use if your child is taking the blood thinning drug warfarin. When using this product do not exceed recommended dosage (see overdose warning) Stop use and ask a doctor if new symptoms occur redness or swelling is present pain gets worse or lasts more than 5 days fever gets worse or lasts more than 3 days These could be signs of a serious condition. Keep out of reach of children. Overdose warning: Taking more than the recommended dose (overdose) may cause liver damage. In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away. Quick medical attention is critical even if you do not notice any signs or symptoms.

Adverse Reactions

Not available.

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