Acetaminophen Oral Chewable 80 mg

FDA Drug Profile — Calmour Childrens Acetaminophen Strips Chewable

Drug Details

Generic Name
Acetaminophen Oral Chewable 80 mg
Brand Names
Calmour Childrens Acetaminophen Strips Chewable
Application Number
M013
Sponsor
Calmour
NDC Codes
1
Dosage Forms
STRIP
Routes
ORAL
Active Ingredients
ACETAMINOPHEN

Indications and Usage

Uses Temporarily: ■ reduces fever ■ relieves minor aches and pains due to: ■ flu ■ the common cold ■ 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 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 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: 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.