IBUPROFEN  - ibuprofen capsule, liquid filled 
Walgreen Company

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Active ingredient(s)


(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

Use(s)

Warnings

  Allergy alerts: 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:

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

Pregnancy/Breastfeeding


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

Directions

Other information

Inactive ingredients


 Ammonium hydroxide, FD&C green no.3, Gelatin, Iron oxide black, Medium chain triglycerides, Polyethylene glycol, Propylene glycol, Potassium hydroxide, Purified water, Shellac, Sorbitol, Sorbitan monooleate

Principal Display Panel

20ct_Carton

20ct_Carton
20ct_Label

20ct_Label



 

Questions or Comments? 1-877-586-7979

IBUPROFEN  
ibuprofen capsule, liquid filled
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0363-0003
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
IBUPROFEN (UNII: WK2XYI10QM) (IBUPROFEN - UNII:WK2XYI10QM) IBUPROFEN200 mg
Inactive Ingredients
Ingredient NameStrength
AMMONIA (UNII: 5138Q19F1X)  
FD&C GREEN NO. 3 (UNII: 3P3ONR6O1S)  
GELATIN (UNII: 2G86QN327L)  
SORBITOL (UNII: 506T60A25R)  
WATER (UNII: 059QF0KO0R)  
SHELLAC (UNII: 46N107B71O)  
SORBITAN MONOOLEATE (UNII: 06XEA2VD56)  
POLYETHYLENE GLYCOL (UNII: 3WJQ0SDW1A)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)  
Product Characteristics
ColorGREENScoreno score
ShapeCAPSULESize19mm
FlavorImprint Code 133
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0363-0003-201 in 1 CARTON
120 in 1 BOTTLE
2NDC:0363-0003-401 in 1 CARTON
240 in 1 BOTTLE
3NDC:0363-0003-801 in 1 CARTON
380 in 1 BOTTLE
4NDC:0363-0003-161 in 1 CARTON
4160 in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07920505/09/2011
Labeler - Walgreen Company (008965063)
Establishment
NameAddressID/FEIBusiness Operations
Aphena Pharma Solutions - Kentucky, LLC.965013498repack
Establishment
NameAddressID/FEIBusiness Operations
Marksans Pharma Limited925822975manufacture

Revised: 5/2012
Document Id: 5ced2456-e28d-4dc7-8255-a27b22b486b7
Set id: d4569486-e581-4671-b32c-1903abfa726e
Version: 1
Effective Time: 20120522
 
Walgreen Company