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Acetaminophen, Ibuprofen Dailymed



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Active Ingredients (in Each Caplet)


Acetaminophen 250 mg

Ibuprofen 125 mg (NSAID*)

*nonsteroidal anti-inflammatory drug

Purposes


Pain reliever

Pain reliever

Indications & Usage Section


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

Warnings Section


Warnings

Acetaminophen liver damage warning:


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:
skin reddeningbulersrash
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•
•

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:
hivesfacial swellingasthma (wheezing)shockskin reddeningrashbulers
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•
•
•
•
•
•

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

NSAID stomach bleeding warning:


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

Heart attack and stroke warning:


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.

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

Ask a doctor before use if

  • •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

Ask a doctor or pharmacist before use if you are

  • •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

When using this product

  • •take with food or milk if stomach upset occurs

Stop use and ask a doctor if

  • •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

OTC - PREGNANCY OR BREAST FEEDING SECTION


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.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION


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.

Dosage & Administration Section


Directions
  • • do not take more than directed
take 2 caplets every 8 hours while symptoms persistask a doctor

adults and children 12 years and over
•

children under 12 years
•
  • •do not take more than 6 caplets in 24 hours, unless directed by a doctor

Storage And Handling Section


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 Ingredient Section


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

Otc - Questions Section


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

Principal Display Panel


NDC 72657-157-74

Acetaminophen 250 mg and Ibuprofen (NSAID) 125 mg Tablets

Pain Reliever

144’sCaplets* *Capsule-Shaped Tablets

DISCLAIMER:

"This tool does not provide medical advice, and is for informational and educational purposes only, and is not a substitute for professional medical advice, treatment or diagnosis. Call your doctor to receive medical advice. If you think you may have a medical emergency, please dial 911."

"Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service."

"This product uses publicly available data from the U.S. National Library of Medicine (NLM), National Institutes of Health, Department of Health and Human Services; NLM is not responsible for the product and does not endorse or recommend this or any other product."

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