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IBUPROFEN IMMEDIATE RELEASE by Strides Pharma Inc.

Medically reviewed on October 10, 2017

Dosage form: tablet, coated
Ingredients: IBUPROFEN 200mg
Labeler: Strides Pharma Inc.
NDC Code: 59556-806


Nuprin®
Ibuprofen Tablets, USP 200 mg
Drug Facts

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





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


IBUPROFEN  IMMEDIATE RELEASE
ibuprofen tablet, coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59556-806
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
IBUPROFEN (IBUPROFEN) IBUPROFEN200 mg
Inactive Ingredients
Ingredient NameStrength
SILICON DIOXIDE 
MAGNESIUM STEARATE 
CELLULOSE, MICROCRYSTALLINE 
STARCH, PREGELATINIZED CORN 
SODIUM STARCH GLYCOLATE TYPE A POTATO 
HYPROMELLOSE 2910 (6 MPA.S) 
TITANIUM DIOXIDE 
TRIACETIN 
TALC 
D&C YELLOW NO. 10 
Product Characteristics
ColorYELLOWScoreno score
ShapeCAPSULE (CAPLET SHAPED) Size14mm
FlavorImprint CodeN
Contains    
Packaging
#Item CodePackage Description
1NDC:59556-806-411 BOTTLE in 1 CARTON
124 TABLET, COATED in 1 BOTTLE
2NDC:59556-806-061 BOTTLE in 1 CARTON
2100 TABLET, COATED in 1 BOTTLE
3NDC:59556-806-081 BOTTLE in 1 CARTON
31000 TABLET, COATED in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA20705208/26/2016
IBUPROFEN  IMMEDIATE RELEASE
ibuprofen tablet, coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59556-805
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
IBUPROFEN (IBUPROFEN) IBUPROFEN200 mg
Inactive Ingredients
Ingredient NameStrength
SILICON DIOXIDE 
MAGNESIUM STEARATE 
CELLULOSE, MICROCRYSTALLINE 
STARCH, PREGELATINIZED CORN 
SODIUM STARCH GLYCOLATE TYPE A POTATO 
HYPROMELLOSE 2910 (6 MPA.S) 
TITANIUM DIOXIDE 
TRIACETIN 
TALC 
D&C YELLOW NO. 10 
Product Characteristics
ColorYELLOWScoreno score
ShapeROUND (ROUND SHAPED) Size10mm
FlavorImprint CodeN
Contains    
Packaging
#Item CodePackage Description
1NDC:59556-805-411 BOTTLE in 1 CARTON
124 TABLET, COATED in 1 BOTTLE
2NDC:59556-805-061 BOTTLE in 1 CARTON
2100 TABLET, COATED in 1 BOTTLE
3NDC:59556-805-081 BOTTLE in 1 CARTON
31000 TABLET, COATED in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA20705208/26/2016
Labeler - Strides Pharma Inc. (078868278)
Establishment
NameAddressID/FEIOperations
Strides Shasun Limited871402375MANUFACTURE(59556-805, 59556-806)

 
Strides Pharma Inc.

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Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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