IBUPROFEN AND PSEUDOEPHEDRINE HCL - ibuprofen and pseudoephedrine hcl capsule, liquid filled 
WALGREEN CO.

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Ibuprofen and Pseudoephedrine HCl Capsules 200 mg/30 mg

Drug Facts

Active ingredients (in each liquid-filled capsule)

Solubilized ibuprofen equal to 200 mg ibuprofen USP (NSAID)*
(present as the free acid and potassium salt)
Pseudoephedrine Hydrochloride USP 30 mg
*nonsteroidal anti-inflammatory drug

Purposes

Pain reliever/fever reducer
Nasal decongestant

Uses

temporarily relieves these symptoms associated with the common cold or flu:

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

Directions

●   do not take more than directed
●   the smallest effective dose should be used
●   adults and children 12 years of age and over:
        ●   take 1 capsule every 4 to 6 hours while symptoms persist. If symptoms do not respond to 1 capsule, 2 capsules may be used.
        ●   do not use more than 6 capsules in any 24-hour period unless directed by a doctor
●   children under 12 years of age: do not use
 

Other information


Inactive ingredients

Black iron oxide, D&C yellow no. 10, gelatin, hypromellose, neelicert FD&C red no. 40, polyethylene glycol, potassium hydroxide, propylene glycol, sorbitol sorbitan solution.

Questions or comments?
call 1-855-274-4122

Product inside sealed in blister with foil backing.
Do not use if blister or foil barrier is broken.

DISTRIBUTED BY:
WALGREEN CO.
200 WILMOT ROAD.,
DEERFIELD, IL 60015

MADE IN INDIA
Code: TS/DRUGS/22/2009

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 200 mg/30 mg (20 Liquid-Filled Capsules)

Walgreens
Compare to Advil® Cold & Sinus
active ingredients

NDC 0363-1106-67

NON-DROWSY
Wal-Profen® D
COLD & SINUS
IBUPROFEN AND PSEUDOEPHEDRINE HCL CAPSULES 200 mg/30 mg
Ibuprofen 200 mg - Pain Reliever/Fever Reducer (NSAID)
Pseudoephedrine HCl 30 mg - Nasal Decongestant

20 LIQUID-FILLED CAPSULES
(2 X 10 capsules per blister card)

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 200 mg/30 mg (20 Liquid-Filled Capsules)


IBUPROFEN AND PSEUDOEPHEDRINE HCL 
ibuprofen and pseudoephedrine hcl capsule, liquid filled
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0363-1106
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
IBUPROFEN (UNII: WK2XYI10QM) (IBUPROFEN - UNII:WK2XYI10QM) IBUPROFEN200 mg
PSEUDOEPHEDRINE HYDROCHLORIDE (UNII: 6V9V2RYJ8N) (PSEUDOEPHEDRINE - UNII:7CUC9DDI9F) PSEUDOEPHEDRINE HYDROCHLORIDE30 mg
Inactive Ingredients
Ingredient NameStrength
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
GELATIN, UNSPECIFIED (UNII: 2G86QN327L)  
HYPROMELLOSE 2910 (6 MPA.S) (UNII: 0WZ8WG20P6)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
POLYETHYLENE GLYCOL 600 (UNII: NL4J9F21N9)  
POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
SORBITOL (UNII: 506T60A25R)  
Product Characteristics
ColorORANGE (Light Orange to Light Yellow with a Slight Orange hue) Scoreno score
ShapeOVALSize15mm
FlavorImprint Code IBP200
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0363-1106-672 in 1 CARTON12/01/2017
110 in 1 BLISTER PACK; Type 0: Not a Combination Product
2NDC:0363-1106-084 in 1 CARTON12/01/2017
210 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA20923512/01/2017
Labeler - WALGREEN CO. (008965063)
Registrant - Aurohealth LLC (078728447)
Establishment
NameAddressID/FEIBusiness Operations
Aurobindo Pharma Limited650381903ANALYSIS(0363-1106) , MANUFACTURE(0363-1106)

Revised: 10/2019
Document Id: 660d30d2-9e11-4740-9afc-4b30179f59f2
Set id: 1cc6e3f0-64f7-4974-a62c-5db46ca9e7c5
Version: 3
Effective Time: 20191014
 
WALGREEN CO.