Acetaminophen 80mg/piece

FDA Drug Profile — DrKids Childrens Pain and Fever

Drug Details

Generic Name
Acetaminophen 80mg/piece
Brand Names
DrKids Childrens Pain and Fever
Application Number
M013
Sponsor
CalmCo LLC
NDC Codes
1
Dosage Forms
BAR, CHEWABLE
Routes
ORAL
Active Ingredients
ACETAMINOPHEN

Indications and Usage

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

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 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 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 occur redness or swelling is present. These could be signs of a serious condition. Keep out of reach of children. Overdose warning: In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-12220 Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.