IBUPROFEN IMMEDIATE RELEASE- ibuprofen tablet, coated 
Strides Pharma Inc

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Ibuprofen Tablets USP, 200 mg
Drug Facts

Important: Read all product information before using.

Keep the box for important information.

 Active ingredient (in each Brown tablet or caplet**)

Ibuprofen 200 mg (NSAID)*

* nonsteroidal anti-inflammatory drug

**capsule-shaped tablets

Purpose

Pain reliever / fever reducer

Uses

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 a doctor if

If pregnant or breast-feeding, ask a health professional before use. It is especially important not to use ibuprofen at 20 weeks or later in 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

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 Ingredients

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)

Manufactured by:

Strides Pharma Science Limited,

Puducherry - 605 014, India.

Distributed by:

Strides Pharma Inc.

East Brunswick, NJ 08816

January 2022

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

label
label
IBUPROFEN  IMMEDIATE RELEASE
ibuprofen tablet, coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59556-857
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
IBUPROFEN (UNII: WK2XYI10QM) (IBUPROFEN - UNII:WK2XYI10QM) IBUPROFEN200 mg
Inactive Ingredients
Ingredient NameStrength
STARCH, CORN (UNII: O8232NY3SJ)  
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
TRIACETIN (UNII: XHX3C3X673)  
TALC (UNII: 7SEV7J4R1U)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
Product Characteristics
ColorBROWNScoreno score
ShapeROUND (Round shaped) Size10mm
FlavorImprint Code IBU200
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:59556-857-4210000 in 1 BAG; Type 0: Not a Combination Product03/18/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07912903/18/2022
IBUPROFEN  IMMEDIATE RELEASE
ibuprofen tablet, coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59556-858
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
IBUPROFEN (UNII: WK2XYI10QM) (IBUPROFEN - UNII:WK2XYI10QM) IBUPROFEN200 mg
Inactive Ingredients
Ingredient NameStrength
STARCH, CORN (UNII: O8232NY3SJ)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
TRIACETIN (UNII: XHX3C3X673)  
TALC (UNII: 7SEV7J4R1U)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
Product Characteristics
ColorBROWNScoreno score
ShapeCAPSULE (capsule shaped) Size14mm
FlavorImprint Code IBU200
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:59556-858-4210000 in 1 BAG; Type 0: Not a Combination Product03/18/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07912903/18/2022
Labeler - Strides Pharma Inc (078868278)
Registrant - Strides Pharma Global Pte. Ltd. (659220961)
Establishment
NameAddressID/FEIBusiness Operations
Strides Pharma Science Limited871402375ANALYSIS(59556-857, 59556-858) , MANUFACTURE(59556-857, 59556-858) , PACK(59556-857, 59556-858)
Establishment
NameAddressID/FEIBusiness Operations
Vivimed Life Sciences Private Limited860477684ANALYSIS(59556-857, 59556-858) , MANUFACTURE(59556-857, 59556-858) , PACK(59556-857, 59556-858)

Revised: 4/2023
Document Id: 9eaf5381-212b-4400-8d73-ae39d0a1c9a2
Set id: a5dd275f-f388-44ec-8297-74430a742d52
Version: 3
Effective Time: 20230413
 
Strides Pharma Inc