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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

IMPRINT: N     SHAPE: round
    COLOR: yellow

  1. FDA Adverse Reactions

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Active Ingredient(s)


(in each yellow 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 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 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

  • 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 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

  • 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

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 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 3days
  • 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 ibuprofenduring 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 Center right away. (1-800-222-1222)

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
  • see end panel for lot number and expiration date
  • Sodium free
  • Each tablet contains 0.714mg of Magnesium

Inactive Ingredient (s)


colloidal silicon dioxide, corn starch, D&C yellow no.10 aluminum lake, hypromellose, magnesium stearate, microcrystalline cellulose, pregelatinized starch, sodium starch glycolate, talc, titanium dioxide and triacetin QUESTIONS OR COMMENTS? Call 1-855-742-7868 (toll-free) MADE IN INDIAMfg.Lic.NO. : PON/DRUGS/16 13 4193 NUPRIN® is a registered trademark of Strides Pharma, Inc. Manufactured for:Strides Pharma Inc.East Brunswick, NJ 08816www.nuprin.com August  2017

Principal Display Panel


Package Label (Round Shaped Tablets) - Principal Display Panel - 100 - Count Bottle Carton, 200 mg Tablets See New Warnings NDC 59556-805-06 100 Coated Tablets

Nuprin®

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

Package Label (Round Shaped Tablets) - Principal Display Panel - 100 - Count Bottle Label, 200 mg Tablets
 Do not use if imprinted safety seal under cap is broken or missing

NDC 59556-805-06 100 Coated Tablets

Nuprin®

Ibuprofen Tablets, USP  200 mg Pain Reliever/Fever Reducer (NSAID)*Important: Read all product information before using. Keep the box for important information *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."

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