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

----------


Drugs Facts

ACTIVE INGREDIENT(S)

(ineach orange 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 USP 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 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 care professional before use. it is especially important not to use ibuprofen USP
 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 centre (1-800-222-1222) right away.

DIRECTIONS



INACTIVE INGREDIENTS (S)


colloidal silicon dioxide, corn starch, hypromellose,  magnesium stearate, microcrystalline cellulose, pregelatinized starch, red iron oxide, sodium starch glycolate, talc, titanium dioxide and triacetin

QUESTIONS OR COMMENTS?
Call 1-855-742-7868 (toll-free): weekdays 8.00 AM to 8.00 PM EST

Manufactured by:
Strides Shasun Limited,
Puducherry - 605 014, India.
PON/DRUGS/16134193

Distributed by:
Strides Pharma Inc.
East Brunswick, NJ 08816


May 2017



PRINCIPAL DISPLAY PANEL


Package Label (Caplet Shaped Tablets) - Principal Display Panel - 24 - Count Bottle, 200 mg Tablets

See New Warnings

NDC 59556-856-41

Ibuprofen Tablets, USP

200 mg

Pain Reliever/Fever Reducer (NSAID)*

24 Coated Caplets**

**capsule-shaped tablets

*nonsteroidal anti-inflammatory drug

ibu-24-cap-car

 


ibu-24-cap-cont



Package Label (Round Shaped Tablets) - Principal Display Panel - 24 - Count Bottle, 200 mg Tablets


See New Warnings

NDC 59556-855-41

Ibuprofen Tablets, USP

200 mg

Pain Reliever/Fever Reducer (NSAID)*

24 Coated Tablets

*nonsteroidal anti-inflammatory drug

ibu-24-tab-car




ibu-24-tab-cont






IBUPROFEN  IMMEDIATE RELEASE
ibuprofen tablet, coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59556-856
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)  
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
TALC (UNII: 7SEV7J4R1U)  
Product Characteristics
ColorORANGEScoreno score
ShapeCAPSULE (CAPLET SHAPED) Size14mm
FlavorImprint Code IBU200
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:59556-856-411 in 1 CARTON04/04/2011
124 in 1 BOTTLE; Type 0: Not a Combination Product
2NDC:59556-856-251 in 1 CARTON04/04/2011
250 in 1 BOTTLE; Type 0: Not a Combination Product
3NDC:59556-856-061 in 1 CARTON04/04/2011
3100 in 1 BOTTLE; Type 0: Not a Combination Product
4NDC:59556-856-441 in 1 CARTON04/04/2011
4165 in 1 BOTTLE; Type 0: Not a Combination Product
5NDC:59556-856-071 in 1 CARTON04/04/2011
5500 in 1 BOTTLE; Type 0: Not a Combination Product
6NDC:59556-856-081 in 1 CARTON04/04/2011
61000 in 1 BOTTLE; Type 0: Not a Combination Product
7NDC:59556-856-461000 in 1 BAG; Type 0: Not a Combination Product04/04/2011
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA09135504/04/2011
IBUPROFEN  IMMEDIATE RELEASE
ibuprofen tablet, coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59556-855
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)  
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
TALC (UNII: 7SEV7J4R1U)  
Product Characteristics
ColorWHITEScoreno score
ShapeROUND (ROUND SHAPED) Size10mm
FlavorImprint Code IBU200
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:59556-855-411 in 1 CARTON04/04/2011
124 in 1 BOTTLE; Type 0: Not a Combination Product
2NDC:59556-855-251 in 1 CARTON04/04/2011
250 in 1 BOTTLE; Type 0: Not a Combination Product
3NDC:59556-855-061 in 1 CARTON04/04/2011
3100 in 1 BOTTLE; Type 0: Not a Combination Product
4NDC:59556-855-441 in 1 CARTON04/04/2011
4165 in 1 BOTTLE; Type 0: Not a Combination Product
5NDC:59556-855-071 in 1 CARTON04/04/2011
5500 in 1 BOTTLE; Type 0: Not a Combination Product
6NDC:59556-855-081 in 1 CARTON04/04/2011
61000 in 1 BOTTLE; Type 0: Not a Combination Product
7NDC:59556-855-461000 in 1 BAG; Type 0: Not a Combination Product04/04/2011
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA09135504/04/2011
Labeler - Strides Pharma Inc. (078868278)
Establishment
NameAddressID/FEIBusiness Operations
Strides Shasun Limited871402375ANALYSIS(59556-855, 59556-856) , MANUFACTURE(59556-855, 59556-856)

Revised: 5/2017
Document Id: 1f4159ad-d58c-4519-932b-030cc2735514
Set id: 1f4159ad-d58c-4519-932b-030cc2735514
Version: 1
Effective Time: 20170526
 
Strides Pharma Inc.