IBUPROFEN IMMEDIATE RELEASE- ibuprofen tablet, coated 
Strides Pharma Inc.

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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)

WARNINGS

Allergy alert

Ibuprofen may cause a severe allergic reaction, especially in people allergic to aspirin. Symptoms may include:

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:

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

ASK A DOCTOR BEFORE USE IF

ASK A DOCTOR OR PHARMACIST BEFORE USE IF

WHEN USING THIS PRODUCT

STOP USE AND ASK DOCTOR IF

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

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



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


nuprin-100s-containr-lbl
IBUPROFEN  IMMEDIATE RELEASE
ibuprofen tablet, coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59556-806
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
IBUPROFEN (UNII: WK2XYI10QM) (IBUPROFEN - UNII:WK2XYI10QM) IBUPROFEN200 mg
Inactive Ingredients
Ingredient NameStrength
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
STARCH, PREGELATINIZED CORN (UNII: O8232NY3SJ)  
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
HYPROMELLOSE 2910 (6 MPA.S) (UNII: 0WZ8WG20P6)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
TRIACETIN (UNII: XHX3C3X673)  
TALC (UNII: 7SEV7J4R1U)  
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
Product Characteristics
ColorYELLOWScoreno score
ShapeCAPSULE (CAPLET SHAPED) Size14mm
FlavorImprint Code N
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:59556-806-411 in 1 CARTON08/26/2016
124 in 1 BOTTLE; Type 0: Not a Combination Product
2NDC:59556-806-061 in 1 CARTON08/26/2016
2100 in 1 BOTTLE; Type 0: Not a Combination Product
3NDC:59556-806-081 in 1 CARTON08/26/2016
31000 in 1 BOTTLE; Type 0: Not a Combination Product
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 AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
IBUPROFEN (UNII: WK2XYI10QM) (IBUPROFEN - UNII:WK2XYI10QM) IBUPROFEN200 mg
Inactive Ingredients
Ingredient NameStrength
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
STARCH, PREGELATINIZED CORN (UNII: O8232NY3SJ)  
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
HYPROMELLOSE 2910 (6 MPA.S) (UNII: 0WZ8WG20P6)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
TRIACETIN (UNII: XHX3C3X673)  
TALC (UNII: 7SEV7J4R1U)  
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
Product Characteristics
ColorYELLOWScoreno score
ShapeROUND (ROUND SHAPED) Size10mm
FlavorImprint Code N
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:59556-805-411 in 1 CARTON08/26/2016
124 in 1 BOTTLE; Type 0: Not a Combination Product
2NDC:59556-805-061 in 1 CARTON08/26/2016
2100 in 1 BOTTLE; Type 0: Not a Combination Product
3NDC:59556-805-081 in 1 CARTON08/26/2016
31000 in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA20705208/26/2016
Labeler - Strides Pharma Inc. (078868278)
Establishment
NameAddressID/FEIBusiness Operations
Strides Shasun Limited871402375MANUFACTURE(59556-805, 59556-806)

Revised: 10/2017
Document Id: ea87a1e7-61da-4204-b8fb-82a028bba42f
Set id: 8ad91d2f-8f49-444a-bc1b-07a4f9ef5aed
Version: 8
Effective Time: 20171010
 
Strides Pharma Inc.