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Ibuprofen (ibuprofen 200 mg) Dailymed

  1. Human OTC
  2. Nonsteroidal Anti-inflammatory Drug
  3. Strides Pharma Inc.

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

Ibuprofen tablet, coated - (ibuprofen 200 mg) image

  1. FDA Adverse Reactions

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Active Ingredient(s


(ineach orange tablet or caplet ** )

Ibuprofen USP 200 mg (NSAID)*

*nonsteroidal anti-inflammatory drug

**capsule-shaped tablets                               

Purpose


Pain reliever/fever reducer

Use(s)

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

Warnings


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

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:
  • 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 non prescription 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 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 ibuprofen or any other pain reliever / fever reducer
  • right before or after heart surgery

Ask A Doctor Before Use If

  • you have problems or serious side effects from taking pain relievers or fever reducers
  • the stomach bleeding warning applies to you
  • you have a history of stomach problems, such ad 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

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

When Using This Product

  • take with food or milk if stomach upset occurs
  • the risk of heart attack or stroke may increase if you use more than directed or for longer than directed

Stop Use And Ask Doctor If

  • you experience any of the following signs of stomach bleeding
    •  feel faint
    • vomit blood
    • have bloody or black stools
    • have stomach pain that does not get better
  • you have symptoms of heart problems or stroke:
    • chest pain
    • trouble in breathing
    • weakness in one part or side of body
    • slurred speech
    • leg swelling
  • 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 care professional before use. it is especially important not to use ibuprofen USP  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.

Keep Out Of Reach Of Children


In case of overdose, get medical help or contact a poison control centre (1-800-222-1222) right away.

Directions

  • do not take more than directed
  • the smallest effective dose should be used
     adults and children 12 years and older
    •  take 1 tablet or caplet every 4 to 6 hours while symptoms persist
    • if pain or fever does not respond to 1 tablet or caplet, 2 tablets or caplets may be used
    • do not exceed 6 tablets or caplets in 24 hours, unless directed by a doctor
     children under 12 years
    •  ask a doctor
    OTHER INFORMATION
  • store between 20°-25°C (68° - 77°F)
  • do not use if imprinted text "SEALED FOR YOUR PROTECTION" on the safety seal under cap is broken or missing
  • Sodium free 
  • Each tablet contains 0.714 mg of Magnesium
  • see end panel for lot number and expiration date.

Inactive Ingredients (s)


colloidal silicon dioxide, corn starch, hypromellose,  magnesium stearate, microcrystalline cellulose, pregelatinized starch, red iron oxide, sodium starch glycolate, talc, titanium dioxide and triacetin QUESTIONS OR COMMENTS?Call 1-855-742-7868 (toll-free): weekdays 8.00 AM to 8.00 PM EST Manufactured by:Strides Shasun Limited,Puducherry - 605 014, India.PON/DRUGS/16134193 Distributed by:Strides Pharma Inc.East Brunswick, NJ 08816 May 2017

Principal Display Panel


Package Label (Caplet Shaped Tablets) - Principal Display Panel - 24 - Count Bottle, 200 mg Tablets

See New Warnings

NDC 59556-856-41

Ibuprofen Tablets, USP

200 mg

Pain Reliever/Fever Reducer (NSAID)*

24 Coated Caplets**

**capsule-shaped tablets

*nonsteroidal anti-inflammatory drug

 



Package Label (Round Shaped Tablets) - Principal Display Panel - 24 - Count Bottle, 200 mg Tablets

See New Warnings

NDC 59556-855-41

Ibuprofen Tablets, USP

200 mg

Pain Reliever/Fever Reducer (NSAID)*

24 Coated Tablets

*nonsteroidal anti-inflammatory drug

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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