IBUPROFEN IMMEDIATE RELEASE- ibuprofen tablet, coated 
Strides Pharma Inc

----------

Drug Facts

ACTIVE INGREDIENT(S)

(in each white 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:

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 YOU ARE

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 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, hypromellose, magnesium stearate, microcrystalline cellulose, pregelatinized starch, sodium starch glycolate, talc, titanium dioxide and triacetin

QUESTIONS OR COMMENTS?

Call 1-855-742-7868

Manufactured by:

Strides Shasun Limited,

Puducherry - 605 014, India

PON/DRUGS/16134193

Distributed by:

Strides Pharma Inc

East Brunswick, NJ 08816

July 2017

PRINCIPAL DISPLAY PANEL

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

NDC 59556-811-41

Ibuprofen Tablets USP

200 mg

Pain Reliever/Fever Reducer (NSAID)*

24 Coated Tablets

*nonsteroidal anti-inflammatory drug

24 Coated round coated
24 s round bottle

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

NDC 59556-812-41

Ibuprofen Tablets USP

200 mg

Pain Reliever/Fever Reducer (NSAID)*

24 Coated Caplets**

**capsule-shaped tablets

*nonsteroidal anti-inflammatory drug

24s caplet carton
24s caplet bottle
IBUPROFEN  IMMEDIATE RELEASE
ibuprofen tablet, coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59556-812
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)  
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)  
STARCH, CORN (UNII: O8232NY3SJ)  
Product Characteristics
ColorWHITEScoreno score
ShapeCAPSULE (CAPLET SHAPED) Size14mm
FlavorImprint Code IBU200
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:59556-812-411 in 1 CARTON06/29/2018
124 in 1 BOTTLE; Type 0: Not a Combination Product
2NDC:59556-812-251 in 1 CARTON06/29/2018
250 in 1 BOTTLE; Type 0: Not a Combination Product
3NDC:59556-812-061 in 1 CARTON06/29/2018
3100 in 1 BOTTLE; Type 0: Not a Combination Product
4NDC:59556-812-441 in 1 CARTON06/29/2018
4165 in 1 BOTTLE; Type 0: Not a Combination Product
5NDC:59556-812-081 in 1 CARTON06/29/2018
51000 in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA20698906/29/2018
IBUPROFEN  IMMEDIATE RELEASE
ibuprofen tablet, coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59556-811
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)  
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)  
STARCH, CORN (UNII: O8232NY3SJ)  
Product Characteristics
ColorWHITEScoreno score
ShapeROUND (ROUND SHAPED) Size10mm
FlavorImprint Code IBU200
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:59556-811-411 in 1 CARTON06/29/2018
124 in 1 BOTTLE; Type 0: Not a Combination Product
2NDC:59556-811-251 in 1 CARTON06/29/2018
250 in 1 BOTTLE; Type 0: Not a Combination Product
3NDC:59556-811-061 in 1 CARTON06/29/2018
3100 in 1 BOTTLE; Type 0: Not a Combination Product
4NDC:59556-811-441 in 1 CARTON06/29/2018
4165 in 1 BOTTLE; Type 0: Not a Combination Product
5NDC:59556-811-081 in 1 CARTON06/29/2018
51000 in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA20698906/29/2018
Labeler - Strides Pharma Inc (078868278)
Registrant - Strides Pharma Global Pte. Ltd. (659220961)
Establishment
NameAddressID/FEIBusiness Operations
Strides Pharma Science Limited871402375ANALYSIS(59556-811, 59556-812) , MANUFACTURE(59556-811, 59556-812) , PACK(59556-811, 59556-812)

Revised: 12/2019
Document Id: 145307ef-a92d-41b6-adea-24f4fc91b285
Set id: 798053dd-10f6-4c2e-8de8-1222dbd0d169
Version: 2
Effective Time: 20191226
 
Strides Pharma Inc