Advil Allergy Sinus (chlorpheniramine maleate, ibuprofen, and psuedoephedrine HCl)

ADVIL ALLERGY SINUS - chlorpheniramine maleate, ibuprofen and pseudoephedrine hydrochloride tablet, coated 
Wyeth Consumer Healthcare

----------

Advil Allergy Sinus
(chlorpheniramine maleate, ibuprofen, and psuedoephedrine HCl)

DRUG FACTS

ACTIVE INGREDIENTS (IN EACH CAPLET)

Chlorpheniramine maleate 2 mg

Ibuprofen 200 mg (NSAID)*

Pseudoephedrine HCl 30 mg

*nonsteroidal anti-inflammatory drug

PURPOSES

Antihistamine

Pain reliever/fever reducer

Nasal decongestant

USES

temporarily relieves these symptoms associated with hay fever or other upper respiratory allergies, and the common cold:

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

carnauba wax, colloidal silicon dioxide, corn starch, croscarmellose sodium, FD&C red no. 40 aluminum lake, FD&C yellow no. 6 aluminum lake, glyceryl behenate, hypromellose, microcrystalline cellulose, pharmaceutical ink, polydextrose, polyethylene glycol, pregelatinized starch, propylene glycol, silicon dioxide, titanium dioxide

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 ALLERGY SINUS

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

Psuedoephedrine HCl 30 mg >> Nasal Decongestant

Chlorpheniramine Maleate 2 mg >> Antihistamine

Relieves Runny Nose, Nasal Congestion, Sneezing, Itchy, Watery Eyes, Headache and Sinus Pressure

ONLY 1 PILL EVERY 4-6 HOURS

20 COATED CAPLETS*

*Capsule-Shaped Tablets

Wyeth Consumer Healthcare

Madison, NJ 07940 USA © 2008 Wyeth

Appearance of the orange Advil Allergy Sinus caplet is a trademark of Wyeth Consumer Healthcare

For most recent product information, visit www.advil.com

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.

Advil Allergy Sinus Packaging

ADVIL ALLERGY SINUS 
chlorpheniramine maleate, ibuprofen, pseudoephedrine hcl   tablet, coated
Product Information
Product TypeHUMAN OTC DRUGNDC Product Code (Source)0573-0188
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
chlorpheniramine maleate (chlorpheniramine ) chlorpheniramine maleate2 mg
ibuprofen (ibuprofen) ibuprofen200 mg
pseudoephedrine hydrochloride (pseudoephedrine ) pseudoephedrine hydrochloride30 mg
Inactive Ingredients
Ingredient NameStrength
No Inactive Ingredients Found
Product Characteristics
ColorORANGE (orange) Score no score
ShapeOVAL (oval shaped tablet) Size15mm
FlavorImprint Code Advil;A;S
Contains    
Packaging
#NDCPackage DescriptionMultilevel Packaging
10573-0188-102 BLISTER PACK In 1 CARTONcontains a BLISTER PACK
110 TABLET In 1 BLISTER PACKThis package is contained within the CARTON (0573-0188-10)

Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA02144112/20/2002

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