Acteaminophen

FDA Drug Profile — Childrens Pain Relief Dye-Free

Drug Details

Generic Name
Acteaminophen
Brand Names
Childrens Pain Relief Dye-Free
Application Number
M013
Sponsor
WinCo Foods, LLC
NDC Codes
1
Dosage Forms
SUSPENSION
Routes
ORAL
Active Ingredients
ACETAMINOPHEN

Indications and Usage

Uses 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 the child takes: more than 5 doses in 24 hours, which is maximum daily amount with other drugs containing acetaminophen Allergy alert: Acetaminophen may cause severeskin 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, or 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 contain acetaminophen, ask a doctor or pharmacist drugs. 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 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 redness or swelling is present new symptoms occur 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 right away. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms. 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 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 if you do not notice any signs or symptoms.