Acetaminophen, Ibuprofen Tablet, Film Coated
FDA Label NDC 72657-157

Acetaminophen 250 mg

Ibuprofen 125 mg (NSAID*)

*nonsteroidal anti-inflammatory drug

Pain reliever

Pain reliever

Uses

• temporarily relieves minor aches and pains due to:
  • oheadache
  • otoothache
  • obackache
  • omenstrual cramps
  • omuscular aches
  • ominor pain of arthritis

Warnings

This product contains acetaminophen. Severe liver damage may occur if you take:

• with other drugs containing acetaminophen
• more than 6 caplets in 24 hours, which is the maximum daily amount for this product
• 3 or more alcoholic drinks every day while using this product

Acetaminophen allergy alert: may cause severe skin reactions. Symptoms may include:

If skin reaction occurs, stop use and seek medical help right away.

NSAID allergy alert: ibuprofen may cause a severe allergic reaction, especially in people allergic to aspirin. Symptoms may include:

If an allergic reaction occurs, stop use and seek medical help right away.

This product contains an NSAID, which may 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 or more alcoholic drinks every day while using this product
• take more or for a longer time than directed

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.

• 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 have ever had an allergic reaction to acetaminophen or any other pain reliever
• right before or after heart surgery

• you have liver disease
• stomach bleeding warning applies to you
• you have problems or serious side effects from taking pain relievers
• you have a history of stomach problems, such as heartburn
• you have high blood pressure, heart disease, liver cirrhosis, kidney disease, asthma, or had a stroke
• you are taking a diuretic

• under a doctor's care for any serious condition
• taking aspirin for heart attack or stroke, because ibuprofen may decrease this benefit of aspirin
• taking any other drug

• take with food or milk if stomach upset occurs

• you experience any of the following signs of stomach bleeding:
  • ofeel faint
  • ovomit blood
  • ohave bloody or black stools
  • ohave stomach pain that does not get better
  • you have symptoms of heart problems or stroke:
    • ochest pain
    • otrouble breathing
    • oweakness in one part or side of body
    • oslurred speech
    • oleg swelling
    • pain gets worse or lasts more than 10 days
    • redness or swelling is present in the painful area
    • any new symptoms appear

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 it may cause problems in the unborn child or complications during delivery.

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Directions

• do not take more than directed

adults and children 12 years and over	take 2 caplets every 8 hours while symptoms persist
children under 12 years	ask a doctor

• do not take more than 6 caplets in 24 hours, unless directed by a doctor

Other information

• read all warnings and directions before use. Keep carton.
• store at 20°C to 25°C (68°F to 77°F)
• avoid excessive heat above 40°C (104°F)

Inactive ingredients

colloidal silicon dioxide, croscarmellose sodium, ferrosoferric oxides, glyceryl dibehenate, hypromellose, iron oxide yellow, iron oxide red, polydextrose, povidone, polyethylene glycol, propylene glycol, shellac, pregelatinized starch and titanium dioxide

Questions or comments?

call weekdays 9 AM to 5 PM at 1 (888) 721-7115

Distributed by:

Glenmark Therapeutics Inc., USA

Mahwah, NJ 07430

March 2023

NDC 72657-157-74

Acetaminophen 250 mg and Ibuprofen (NSAID) 125 mg Tablets

Pain Reliever

144’sCaplets*
*Capsule-Shaped Tablets

Carton144s (Carton144s)