MEDIQUE APAP acetaminophen

FDA Drug Profile — MEDIQUE APAP acetaminophen

Drug Details

Generic Name
MEDIQUE APAP acetaminophen
Brand Names
MEDIQUE APAP acetaminophen
Application Number
M013
Sponsor
HF Acquisition Co LLC, DBA HealthFirst
NDC Codes
1
Dosage Forms
TABLET, COATED
Routes
ORAL
Active Ingredients
ACETAMINOPHEN

Indications and Usage

Uses temporarily relieves minor aches and pains due to: headache muscular aches minor arthritis pain backache the common cold toothache premenstrual and menstrual cramps temporarily reduces fever

Warnings

Warnings Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take: more than 4,000 mg in 24 hours, which is the maximum daily amount with other drugs containing acetaminophen 3 or more alcoholic drinks every day while using this product 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. 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 you are allergic to acetaminophen or any of the inactive ingredients in this product Ask a doctor before use if you have liver disease Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin Stop using and ask a doctor if pain gets worse and lasts for more than 10 days fever gets worse or lasts for more than 3 days new symptoms occur redness or swelling is present These could be signs of a serious condition If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children. Overdose Warning: In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222). Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.