NUPRIN IMMEDIATE RELEASE- ibuprofen tablet, coated 
Strides Arcolab Limited

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Nuprin®
IBUPROFEN TABLETS, USP 200mg
 
Drug Facts

ACTIVE INGREDIENT(S)

(in each tablet)

Ibuprofen USP 200 mg (NSAID)*

*nonsteroidal anti-inflammatory drug

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 a nonsteroidal anti-inflammatory drug (NSAID), which may cause severe stomach bleeding. The chance is higher if you:

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 ibuprofen 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 center (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 every 4 to 6 hours while symptoms persist
  • if pain or fever does not respond to 1 tablet, 2 tablets may be used
  • do not exceed 6 tablets 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, hypromellose, magnesium stearate, microcrystalline cellulose, pregelatinized starch, sodium starch glycolate, talc, titanium dioxide and triacetin

QUESTIONS OR COMMENTS?
Adverse drug event Call (877)-244-9825


MADE IN INDIA

Mfg.Lic.No. DRUGS/PY/05 13 1523

NUPRIN® is a registered trademark of SVADS Holdings SA


Manufactured for:

Strides Pharma Inc,


East Brunswick, NJ 08816
www.nuprin.com
December 2015

PRINCIPAL DISPLAY PANEL

Package Label (Round Shaped Tablets) - Principal Display Panel, 200 mg Tablets
NDC 64380-788-31
400 Coated Tablets
N TMNuprin®
IBUPROFEN TABLETS,USP
200 mg
Pain Reliever/Fever Reducer (NSAID)*
*nonsteroidal anti-inflammatory drug.
400s-label
400s-carton

NUPRIN  IMMEDIATE RELEASE
ibuprofen tablet, coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:64380-788
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, CORN (UNII: O8232NY3SJ)  
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
HYPROMELLOSES (UNII: 3NXW29V3WO)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
TRIACETIN (UNII: XHX3C3X673)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
Product Characteristics
ColorBROWNScoreno score
ShapeROUND (ROUND SHAPED) Size10mm
FlavorImprint Code IBU200
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:64380-788-311 in 1 CARTON
1400 in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07912912/16/2015
Labeler - Strides Arcolab Limited (650738743)
Registrant - Shasun Pharmaceuticals Limited (915786829)
Establishment
NameAddressID/FEIBusiness Operations
Shasun Pharmaceuticals Limited915786829MANUFACTURE(64380-788)

Revised: 2/2016
Document Id: 0aad5cc2-4438-4a6c-a98f-57f370621366
Set id: 78de585a-6b73-4151-93bd-d73fa74a9614
Version: 2
Effective Time: 20160204
 
Strides Arcolab Limited