Acetaminophen

Generic: ACETAMINOPHEN

Over-the-Counter DrugORAL

Drug Information

Brand Name
Acetaminophen
Generic Name
ACETAMINOPHEN
Manufacturer
NuCare Pharmaceuticals,Inc.
Product Type
Over-the-Counter Drug
Route
ORAL
Application Number
004c39cd-b4f4-1cae-e063-6394a90a0697

Active Ingredients

Indications & Usage

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

Warnings

Warnings Liver warning: This product contains acetaminophen. The maximum daily dose of this product is 10 tablets (3,250 mg) in 24 hours for adults or 5 tablets (1,625 mg) in 24 hours for children. Severe liver damage may occur if adult takes more than 4,000 mg of acetaminophen in 24 hours child takes more than 5 doses in 24 hours, which is the maximum daily amount taken with other drugs containing acetaminophen adult has 3 or more alcoholic drinks every day while using this product Allergy aler...

Read full warnings

Warnings Liver warning: This product contains acetaminophen. The maximum daily dose of this product is 10 tablets (3,250 mg) in 24 hours for adults or 5 tablets (1,625 mg) in 24 hours for children. Severe liver damage may occur if adult takes more than 4,000 mg of acetaminophen in 24 hours child takes more than 5 doses in 24 hours, which is the maximum daily amount taken with other drugs containing acetaminophen adult has 3 or more alcoholic drinks every day while using this product Allergy alert: acetaminophen may cause severe skin reactions. Symptoms may include: โ€ข skin reddening โ€ข blisters โ€ข 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 the user has liver disease Ask a doctor or pharmacist before use if the user is taking the blood thinning drug warfarin Stop use and ask a doctor if pain gets worse or lasts more than 10 days in adults pain gets worse or lasts more than 5 days in children under 12 years 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. If pregnant or breast-feeding, ask a health professional before use. Keep out of the reach of children. Overdose warning: In the 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.

Adverse Reactions

No specific warnings reported by FDA for this product.

Medical Disclaimer: This information is for educational purposes only and does not constitute medical advice. Always consult a licensed healthcare provider before making any decisions about your medications. Data sourced from openFDA.

Acetaminophen - Side Effects, Warnings, Uses | FDA Drug Database