ADVIL COLD & SINUS(ibuprofen and pseudoephedrine HCl)

ADVIL COLD AND SINUS - ibuprofen and pseudoephedrine hydrochloride capsule, liquid filled 
Wyeth Consumer Healthcare

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ADVIL COLD & SINUS
(ibuprofen and pseudoephedrine HCl)

DRUG FACTS

ACTIVE INGREDIENTS (IN EACH LIQUID-FILLED CAPSULE)

Solubilized ibuprofen equal to 200 mg ibuprofen (NSAID)*

(present as the free acid and potassium salt)

Pseudoephedrine HCl 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 a nonsteroidal anti-inflammatory drug (NSAID), which may cause stomach bleeding. The chance is higher if you:

Do not use

Ask a doctor before use if you have

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 right away.

DIRECTIONS

OTHER INFORMATION

INACTIVE INGREDIENTS

D&C yellow no. 10, FD&C red no. 40, fractionated coconut oil, gelatin, pharmaceutical ink, polyethylene glycol, potassium hydroxide, purified water, sorbitan, sorbitol

QUESTIONS OR COMMENTS?

call toll-free 1-800-88-ADVIL

PRODUCT PACKAGING

The product packaging shown below represents a sample of that currently in use. Additional packaging may also be available.

Advil COLD & SINUS Liqui-Gels

Non-Drowsy

Ibuprofen 200 mg >> Pain Reliever/Fever Reducer (NSAID)

Pseudoephedrine HCl 30 mg >> Nasal Decongestant

Relieves Sinus Pressure, Nasal Congestion and Fever

32 LIQUID-FILLED CAPSULES

READ AND KEEP CARTON FOR COMPLETE WARNINGS AND INFORMATION

Product inside sealed in plastic blister with foil backing. Do Not Use if plastic blister or foil barrier is broken.

For most recent product information visit www.advil.com

Distributed by: Wyeth Consumer Healthcare

Madison, NJ 07940 USA ©2008 Wyeth

U.S. Patent Nos. 5,071,643 and 5,360,615

LIQUI-GELS is a trademark or registered trademark of Catalent Pharma Solutions.

Advil COLD & SINUS Liqui-Gels Packaging

ADVIL COLD AND SINUS 
ibuprofen, pseudoephedrine hcl   capsule, liquid filled
Product Information
Product TypeHUMAN OTC DRUGNDC Product Code (Source)0573-0184
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ibuprofen (ibuprofen) ibuprofen200 mg
pseudoephedrine hydrochloride (pseudoephedrine) pseudoephedrine hydrochloride30 mg
Inactive Ingredients
Ingredient NameStrength
No Inactive Ingredients Found
Product Characteristics
ColorORANGE (light orange to light yellow with a slight orange hue) Score no score
ShapeOVAL (oval softgel) Size15mm
FlavorImprint Code Advil;C;S;with;black;ink
Contains    
Packaging
#NDCPackage DescriptionMultilevel Packaging
10573-0184-321 BLISTER PACK In 1 CARTONcontains a BLISTER PACK
132 CAPSULE In 1 BLISTER PACKThis package is contained within the CARTON (0573-0184-32)

Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA02137405/30/2002

Labeler - Wyeth Consumer Healthcare (828831730)
Revised: 06/2009Wyeth Consumer Healthcare