IBUPROFEN - ibuprofen capsule 
Aurohealth LLC

----------

Ibuprofen Capsules

Drug Facts

Active ingredient (in each capsule)

Solubilized ibuprofen equal to 200 mg ibuprofen USP (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

■ you have symptoms of heart problems or stroke:

     ■ chest pain                 ■ trouble breathing

     ■ weakness in one part or side of body

     ■ slurred speech           ■ leg swelling 


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 (1-800-222-1222) right away.

Directions

Other information

Inactive ingredients

black iron oxide, FD & C green no. 3,  gelatin,  hypromellose, polyethylene glycol, potassium hydroxide, propylene glycol, sorbitol sorbitan solution

Questions or comments?

call 1-855-274-4122

Distributed by:
AUROHEALTH LLC
279 Princeton-Hightstown Road
East Windsor, NJ 08520

Made in India   

Code No.: TS/DRUGS/22/2009

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 200 mg (40 Capsules Bottle)

NDC 58602-902-12
Ibuprofen Capsules
200 mg
Pain Reliever/Fever Reducer (NSAID)
40 Liquid Filled Capsules

READ ANDA KEEP CARTON FOR COMPLETE
WARNING AND INFORMATION

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 200 mg (40 Capsule Bottle)

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 200 mg (40 Capsules Container Carton)

NDC 58602-902-12
Ibuprofen Capsules
200 mg
Pain Reliever/Fever Reducer (NSAID)
40 Liquid Filled Capsules
READ AND KEEP CARTON FOR COMPLETE
WARNINGS AND INFORMATION
AUROHEALTH

ibuprofen-fig2

IBUPROFEN 
ibuprofen capsule
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58602-902
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
IBUPROFEN (UNII: WK2XYI10QM) (IBUPROFEN - UNII:WK2XYI10QM) IBUPROFEN200 mg
Inactive Ingredients
Ingredient NameStrength
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
FD&C GREEN NO. 3 (UNII: 3P3ONR6O1S)  
GELATIN, UNSPECIFIED (UNII: 2G86QN327L)  
HYPROMELLOSE 2910 (6 MPA.S) (UNII: 0WZ8WG20P6)  
POLYETHYLENE GLYCOL 600 (UNII: NL4J9F21N9)  
POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
SORBITOL (UNII: 506T60A25R)  
1,4-SORBITAN (UNII: AV0YTZ4E6J)  
MANNITOL (UNII: 3OWL53L36A)  
WATER (UNII: 059QF0KO0R)  
ISOPROPYL ALCOHOL (UNII: ND2M416302)  
Product Characteristics
ColorGREENScoreno score
ShapeRECTANGLE (Oblong) Size19mm
FlavorImprint Code I200
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:58602-902-731 in 1 CARTON06/29/2018
120 in 1 BOTTLE; Type 0: Not a Combination Product
2NDC:58602-902-121 in 1 CARTON06/29/2018
240 in 1 BOTTLE; Type 0: Not a Combination Product
3NDC:58602-902-181 in 1 CARTON06/29/2018
380 in 1 BOTTLE; Type 0: Not a Combination Product
4NDC:58602-902-30160 in 1 BOTTLE; Type 0: Not a Combination Product06/29/2018
5NDC:58602-902-38300 in 1 BOTTLE; Type 0: Not a Combination Product06/29/2018
6NDC:58602-902-701 in 1 CARTON03/31/2020
640 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
7NDC:58602-902-721 in 1 CARTON03/31/2020
780 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
8NDC:58602-902-74160 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product03/31/2020
9NDC:58602-902-32180 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product03/31/2020
10NDC:58602-902-34200 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product03/31/2020
11NDC:58602-902-75300 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product03/31/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA20775306/29/2018
Labeler - Aurohealth LLC (078728447)
Establishment
NameAddressID/FEIBusiness Operations
APL HEALTHCARE LIMITED650844777ANALYSIS(58602-902) , MANUFACTURE(58602-902)
Establishment
NameAddressID/FEIBusiness Operations
Aurobindo Pharma Limited650381903ANALYSIS(58602-902) , MANUFACTURE(58602-902)

Revised: 3/2022
Document Id: f2654aa5-8bb3-4f27-9495-0d31c18bf5f8
Set id: 3b0e77a1-b49d-4c67-81dd-66450dabcf3b
Version: 5
Effective Time: 20220304
 
Aurohealth LLC