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🇺🇸US · FDA ApprovedOver-the-counterANDA216592-001

ACETAMINOPHEN AND IBUPROFEN(ACETAMINOPHEN)

Nonsteroidal Anti-inflammatory Drug [EPC]

Manufacturer: GRANULES

FDA Approval: 13/07/2023

Route: ORAL · TABLET

Indications & Usage

Uses ■ temporarily relievesminor aches and pains due to: ■ headache ■ toothache ■ backache ■ menstrual cramps ■ muscular aches ■ minor pain of arthritis

Warnings & Precautions

Acetaminophen liver damage warning: This product contains acetaminophen. Severe liver damagemay occur if you take: ■ with other drugs containing acetaminophen ■ more than 6 caplets in 24 hours,which is themaximumdaily amount for this product ■ 3 or more alcoholic drinks every day while using this product Acetaminophen allergy alert: may cause severe skin reactions.Symptomsmay include: ■ skin reddening ■ blisters ■ rash If skin reaction occurs, stop use and seek medical help right away. NSAID allergy alert: ibuprofenmay cause a severe allergic reaction, especially in people allergic to aspirin. Symptomsmay include: ■ hives ■ facial swelling ■ asthma (wheezing) ■ shock ■ skin reddening ■ rash ■ blisters If an allergic reaction occurs, stop use and seekmedical help right away. NSAID stomach bleedingwarning: This product contains an NSAID, whichmay cause severe stomach bleeding.The chance is higher if you: ■ are age 60 or older ■ have had stomach ulcers or bleeding problems ■ take a blood thinning (anticoagulant) or steroid drug ■ take other drugs containing prescription or nonprescription NSAIDs [aspirin, ibuprofen, naproxen, or others] ■ have 3 ormore alcoholic drinks every day while using this product ■ take more or for a longer time than directed Heart attack and strokewarning: NSAIDs, except aspirin, increase the risk of heart attack, heart failure, and stroke. These can be fatal.The risk is higher if you use more than directed or for longer than directed.

Use in Pregnancy & Lactation

If pregnant or breast-feeding, ask a health professional before use. It is especially important not to use ibuprofen at 20 weeks or later in pregnancy unless definitely directed to do so by a doctor because itmay cause problems in the unborn child or complications during delivery.

Active Ingredients

ACETAMINOPHEN 250MG; IBUPROFEN 125MG

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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.