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Generic: ibuprofen is used for the treatment of Arthritis, Juvenile Arthritis, Rheumatoid Asthma Bursitis Dysmenorrhea Fever Gout Inflammation Menorrhagia Osteoarthritis Pain Pain, Postoperative Pregnancy Trimester, Third Pregnancy, Abdominal Premenstrual Syndrome Rhinitis Spondylitis, Ankylosing Bronchial Hyperreactivity


IMPRINT: 44 438     SHAPE: round
    COLOR: white

All Imprints

ibuprofen 200 mg - 44 438 round white

ibuprofen - ibuprofen 200 mg oral tablet - 44 438 round white

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Active Ingredient (in Each White Tablet)


Ibuprofen USP, 200 mg (NSAID)**nonsteroidal anti-inflammatory drug

Purpose


Pain reliever/fever reducer

Uses

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

Warnings


Allergy alert: Ibuprofen may cause a severe allergic reaction, especially in people allergic to aspirin. Symptoms may include:
  • rash
  • hives
  • shock
  • facial swelling
  • asthma (wheezing)
  • bulers
  • skin reddening

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

Stomach bleeding warning: This product contains an NSAID, which may cause severe stomach bleeding. The chance is higher if you
  • take more or for a longer time than directed
  • take a blood thinning (anticoagulant) or steroid drug
  • have had stomach ulcers or bleeding problems
  • have 3 or more alcoholic drinks every day while using this product
  • take other drugs containing prescription or nonprescription NSAIDs [aspirin, ibuprofen, naproxen, or others]
  • are age 60 or older

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

  • if you have ever had an allergic reaction to any other pain reliever/fever reducer
  • right before or after heart surgery

Ask a doctor before use if

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

Aska 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:
    • feel faint
    • have bloody or black stools
    • vomit blood
    • have stomach pain that does not get better
  • you have symptoms of heart problems or stroke:
    • chest pain
    • slurred speech
    • leg swelling
    • trouble breathing
    • weakness in one part or side of body
  • pain gets worse or lasts more than 10 days
  • fever gets worse or lasts more than 3 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.

Directions

  • do not take more than directed
  • the smallest effective dose should be used
  • adults and children 12 years and over: take 1 tablet every 4 to 6 hours while symptoms persist
    • if pain or fever does not respond to 1 tablet, 2 tablets may be used
    • do not exceed 6 tablets in 24 hours, unless directed by a doctor
  • children under 12 years: ask a doctor

Other Information

  • TAMPER EVIDENT: DO NOT USE IF OUTER PACKAGE IS OPENED OR BLISTER IS TORN OR BROKEN
  • store between 20°-25°C (68°-77°F)
  • avoid excessive heat 40°C (104°F)

Inactive Ingredients


colloidal silicon dioxide, corn starch, hypromellose, lactose anhydrous, magnesium stearate, microcrystalline cellulose, polydextrose, polyethylene glycol, povidone, sodium starch glycolate, stearic acid, triacetin

Questions Or Comments?


Call 1-800-426-9391 8:30 AM-4:00 PM ET, Monday-Friday

Principal Display Panel


NDC 0904-7914-61

MAJOR®

Unit Dose

IBUPROFEN TABLETS, USPPain Reliever/Fever Reducer (NSAID)

 200 mg each

Institutional Dispensing Only100 TABLETS

50844 REV1221D43812

Distributed by:MAJOR® PHARMACEUTICALSIndianapolis, IN 46268(800) 616-2471www.majorpharmaceuticals.com

TAMPER EVIDENT: DO NOT USE IFPACKAGE IS OPENED OR IF BLISTERUNIT IS TORN, BROKEN OR SHOWSANY SIGNS OF TAMPERING

Major 44-438

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."

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"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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