IBUPROFEN - ibuprofen capsule, liquid filled 
Strides Pharma Inc

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DRUG FACTS

READ AND KEEP CARTON FOR COMPLETE WARNINGS AND INFORMATION

Active ingredient (in each capsule)

Solubilized ibuprofen equal to 200 mg ibuprofen (NSAID)*

 (Present as the free acid and potassium salt)

*nonsteroidal anti-inflammatory drug

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.

Directions

Other information

Inactive ingredients

Ibuprofen Capsules

FD&C blue 1, gelatin, gelatin (hydrolyzed), medium chain triglyceride, PEG 600, potassium hydroxide, purified water, sorbital and sorbitan solution.

Printing ink: propylene glycol, shellac resins, sodium lauryl sulphate, titanium dioxide.

Ibuprofen Capsules – Minis

FD&C green no.3, gelatin, gelatin (hydrolyzed), lecithin (Soya Lecithin), medium chain triglyceride, polyethylene Glycol 600, potassium hydroxide, purified water, sorbital and sorbitan solution.

Printing ink: propylene glycol, shellac resins, sodium lauryl sulphate, titanium dioxide.

Questions or comments?

call toll free 1-877-244-9825

Do Not Use if seal under bottle cap imprinted with "SEALED for YOUR PROTECTION" is broken or missing.

For most recent product information, visit us at www.strides.com

Revised: 05/2023

Manufactured by:

Strides Pharma Science Limited

Bengaluru - 562106, India

Distributed by:

Strides Pharma Inc.

East Brunswick, NJ 08816

PRINCIPAL DISPLAY PANELS

Ibuprofen Capsules, 200 mg Pain Reliever/Fever Reducer (NSAID)

Liquid Filled Capsules

160s count
Ibuprofen carton label
80s count

Ibuprofen Capsules, 200 mg Pain Reliever/Fever Reducer (NSAID)

Liquid Filled Capsules - Minis

Ibuprofen minis carton label
80s count minis
160s count minis
IBUPROFEN 
ibuprofen capsule, liquid filled
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59556-764
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
IBUPROFEN (UNII: WK2XYI10QM) (IBUPROFEN - UNII:WK2XYI10QM) IBUPROFEN200 mg
Inactive Ingredients
Ingredient NameStrength
POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)  
POLYETHYLENE GLYCOL 600 (UNII: NL4J9F21N9)  
WATER (UNII: 059QF0KO0R)  
GELATIN (UNII: 2G86QN327L)  
SORBITOL (UNII: 506T60A25R)  
SORBITAN (UNII: 6O92ICV9RU)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
SHELLAC (UNII: 46N107B71O)  
SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
Product Characteristics
ColorGREEN (transparent green to bluish green) Scoreno score
ShapeOVAL (oblong shaped) Size8mm
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:59556-764-291 in 1 CARTON11/16/2022
120 in 1 BOTTLE; Type 0: Not a Combination Product
2NDC:59556-764-121 in 1 CARTON11/16/2022
240 in 1 BOTTLE; Type 0: Not a Combination Product
3NDC:59556-764-131 in 1 CARTON11/16/2022
380 in 1 BOTTLE; Type 0: Not a Combination Product
4NDC:59556-764-111 in 1 CARTON11/16/2022
4120 in 1 BOTTLE; Type 0: Not a Combination Product
5NDC:59556-764-481 in 1 CARTON11/16/2022
5160 in 1 BOTTLE; Type 0: Not a Combination Product
6NDC:59556-764-491 in 1 CARTON11/16/2022
6200 in 1 BOTTLE; Type 0: Not a Combination Product
7NDC:59556-764-501 in 1 CARTON11/16/2022
7300 in 1 BOTTLE; Type 0: Not a Combination Product
8NDC:59556-764-181 in 1 CARTON11/16/2022
8180 in 1 BOTTLE; Type 0: Not a Combination Product
9NDC:59556-764-923000 in 1 BAG; Type 0: Not a Combination Product11/16/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA20446911/16/2022
IBUPROFEN 
ibuprofen capsule, liquid filled
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59556-895
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
IBUPROFEN (UNII: WK2XYI10QM) (IBUPROFEN - UNII:WK2XYI10QM) IBUPROFEN200 mg
Inactive Ingredients
Ingredient NameStrength
POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)  
POLYETHYLENE GLYCOL 600 (UNII: NL4J9F21N9)  
WATER (UNII: 059QF0KO0R)  
GELATIN (UNII: 2G86QN327L)  
SORBITOL (UNII: 506T60A25R)  
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
SHELLAC (UNII: 46N107B71O)  
SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
FD&C GREEN NO. 3 (UNII: 3P3ONR6O1S)  
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
SORBITAN (UNII: 6O92ICV9RU)  
Product Characteristics
ColorGREEN (transparent green to bluish green) Scoreno score
ShapeOVALSize8mm
FlavorImprint Code 469
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:59556-895-291 in 1 CARTON11/16/2022
120 in 1 BOTTLE; Type 0: Not a Combination Product
2NDC:59556-895-131 in 1 CARTON11/16/2022
280 in 1 BOTTLE; Type 0: Not a Combination Product
3NDC:59556-895-481 in 1 CARTON11/16/2022
3160 in 1 BOTTLE; Type 0: Not a Combination Product
4NDC:59556-895-501 in 1 CARTON11/16/2022
4300 in 1 BOTTLE; Type 0: Not a Combination Product
5NDC:59556-895-797000 in 1 BAG; Type 0: Not a Combination Product11/16/2022
6NDC:59556-895-851 in 1 CARTON11/16/2022
680 in 1 BOTTLE; Type 0: Not a Combination Product
7NDC:59556-895-861 in 1 CARTON11/16/2022
7120 in 1 BOTTLE; Type 0: Not a Combination Product
8NDC:59556-895-871 in 1 CARTON11/16/2022
8160 in 1 BOTTLE; Type 0: Not a Combination Product
9NDC:59556-895-391 in 1 CARTON11/16/2022
9200 in 1 BOTTLE; Type 0: Not a Combination Product
10NDC:59556-895-881 in 1 CARTON11/16/2022
10300 in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA20446911/16/2022
Labeler - Strides Pharma Inc (078868278)

Revised: 4/2024
Document Id: 0ea9c8f2-f3f9-4843-90d8-6891d7de650b
Set id: 69b208ff-83f5-40d1-a2ff-d54b390e46e4
Version: 8
Effective Time: 20240415
 
Strides Pharma Inc