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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


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Otc - Active Ingredient Section


Active Ingredient (in each tablet)

Ibuprofen (NSAID)* 200mg (*nonsteroidal anti-inflammatory drug)...Pain Reliever/Fever Reducer



Indications & Usage Section


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

Temporarily reduces fever

Warnings Section


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

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 more or for a longer time than directed
  • take a blood thinning (anticoagulant) or steroid drug
  • have 3 or more alcohol drinks every day while using this product
  • take other drugs containing prescription or non-prescription NSAIDs (aspirin, ibuprofen, naproxen, or others)



Otc - Do Not Use Section


Do not use
  • if you have ever had an allergic reaction to any other pain reliever/fever reducer
  • right before or after heart surgery



Otc - Ask Doctor Section


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, or kidney disease

Otc - Ask Doctor/pharmacist Section


Ask a doctor or pharmacist if you are
  • unders a doctor's care for any serious condition
  • taking any other drug containing an NSAID
  • taking a blood thinning (anticoagulant) or steroid drug
  • taking aspirin for heart attack or stroke (ibuprofen may decrease the benefit of aspirin)





Otc - When Using Section


When using this product
  • take with food or milk if stomach upset occurs
  • long term continuous use may increase the risk of heart attack or stroke

Otc - Stop Use Section


Stop use and ask a doctor if
  • an allergic reaction occurs, seek medical help right away
  • fever gets worse or lasts more than 3 days
  • pain gets worse or lasts more than 10 days
  • redness or swelling is present in the painful area.
  • new symptoms occur
  • you have any of the following signs of stomach bleeding: feel faint, vomit blood, have bloody or black stools, or stomach pain that does not get better

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 during the last 3 months of 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. 1-800-222-1222

Dosage & Administration Section


Directions: do not take more than directed; the smallest effective dose should be used. Adults and children 12 years of age 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 take more than 6 tablets in 24 hours unless directed by a doctor

children under 12 years of age: ask a doctor



Otc - Purpose Section


Ibuprofen...to reduce pain and fever

Inactive Ingredient Section


Inactive ingredients:

Carnauba Wax, Croscarmellose Sodium, Hydroxypropyl Methylcellulose, Microcrystalline Cellulose, Polyethylene Glycol, Polysorbate 80, Povidone, Pregelatinized Starch, Silicon Dioxide, Sodium Starch Clycolate, Stearic Acid, Titanium Dioxide

Package Label.principal Display Panel


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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