Childrens Pain Relief

FDA Drug Profile — Childrens Pain Relief

Drug Details

Generic Name
Childrens Pain Relief
Brand Names
Childrens Pain Relief
Application Number
M013
Sponsor
Allegiant Health
NDC Codes
1
Dosage Forms
LIQUID
Routes
ORAL
Active Ingredients
ACETAMINOPHEN

Indications and Usage

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

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 ever, headache, rash. nausea or vomiting, consult a doctor promptly. Do not use ■ with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist. ■ If your child is allergic to acetaminophen or any other 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 dose (see overdose warning) Stop use and ask a doctor if ■ pain gets worse or lasts more than 5 days ■ fever gets worse or lasts more than 3 days ■ new symptoms ■ redness or swelling is present. 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 for adults as well as for children even if you do not notice any signs or symptoms.