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  5. Label Information: Ibuprofen Immediate Release

FDA Label for Ibuprofen Immediate Release

View Indications, Usage & Precautions

Table of Contents

    1. ACTIVE INGREDIENT(S)
    2. PURPOSE
    3. USE(S)
    4. WARNINGS
    5. DO NOT USE
    6. ASK A DOCTOR BEFORE USE IF
    7. ASK A DOCTOR OR PHARMACIST BEFORE USE IF
    8. WHEN USING THIS PRODUCT
    9. STOP USE AND ASK DOCTOR IF
    10. KEEP OUT OF REACH OF CHILDREN
    11. DIRECTIONS
    12. INACTIVE INGREDIENT (S)
    13. PRINCIPAL DISPLAY PANEL

Ibuprofen Immediate Release Product Label

The following document was submitted to the FDA by the labeler of this product Strides Pharma Inc.. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

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
  • blisters

    • 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 INDIA
Mfg.Lic.NO. : PON/DRUGS/16 13 4193
NUPRIN® is a registered trademark of Strides Pharma, Inc.


Manufactured for:
Strides Pharma Inc.
East Brunswick, NJ 08816
www.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


nuprin-100s-cart-lbl - nuprin round 100s cart label

nuprin-100s-cart-lbl - nuprin round 100s cart label




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



* Please review the disclaimer below.