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🇺🇸US · FDA ApprovedOver-the-counterANDA070608-001

ACETAMINOPHEN

Manufacturer: PERRIGO NEW YORK

FDA Approval: 01/12/1986

Route: RECTAL · SUPPOSITORY

Indications & Usage

Uses temporarily • reduces fever • relieves minor aches, pains, and headache

Warnings & Precautions

Warnings Liver warning: This product contains acetaminophen. Severe liver damage may occur if • an adult or child 12 years and older takes more than 6 doses in 24 hours, which is the maximum daily amount • taken with other drugs containing acetaminophen • an adult takes 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. For rectal use only Do not use • in children under 12 years • if you are allergic to acetaminophen • with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist. Ask a doctor before use if • you have liver disease • you are taking the blood thinning drug warfarin Stop use and ask a doctor if • fever lasts more than 3 days (72 hours), or recurs • pain gets worse or lasts more than 10 days • new symptoms occur • redness or swelling is present in the painful area. These may be signs of a serious condition. If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children. If swallowed or in case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222). Quick medical attention is critical in case of overdose for adults and for children even if you do not notice any signs or symptoms.

Use in Pregnancy & Lactation

If pregnant or breast-feeding, ask a health professional before use.

Active Ingredients

ACETAMINOPHEN 650MG

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Medical disclaimer: This drug information is intended for qualified healthcare professionals only. Always verify with the official FDA prescribing information before clinical use.