Advil Cold & Sinus Caplets(ibuprofen and pseudoephedrine HCl)

ADVIL COLD AND SINUS - ibuprofen and pseudoephedrine hydrochloride tablet, coated 
Wyeth Consumer Healthcare

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Advil Cold & Sinus Caplets
(ibuprofen and pseudoephedrine HCl)

DRUG FACTS

ACTIVE INGREDIENTS (IN EACH CAPLET)

Ibuprofen 200 mg (NSAID)*

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

acetylated monoglycerides, carnauba wax, colloidal silicon dioxide, corn starch, croscarmellose sodium, methylparaben, microcrystalline cellulose, pharmaceutical glaze, pharmaceutical ink, povidone, pregelatinized starch, propylparaben, sodium benzoate, sodium lauryl sulfate, stearic acid, sucrose, synthetic iron oxides, 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 COLD & SINUS

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

Pseudoephedrine HCl 30 mg >> Nasal Decongestant

Non-Drowsy

Relieves Sinus Pressure, Nasal Congestion and Fever

20 COATED CAPLETS*

*Oval-Shaped Tablets

Wyeth Consumer Healthcare

Madison, NJ 07940 USA ©2008 Wyeth

U.S. Patent No. 5,087,454

Appearance of the tan Advil Cold & Sinus caplet is a trademark of Wyeth Consumer Healthcare

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

Advil COLD & SINUS Packaging

READ AND KEEP CARTON FOR COMPLETE WARNINGS AND INFORMATION

LIFT HERE For More Drug Facts

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

Advil COLD & SINUS Packaging - Drug Facts

ADVIL COLD AND SINUS 
ibuprofen, pseudoephedrine hcl   tablet, coated
Product Information
Product TypeHUMAN OTC DRUGNDC Product Code (Source)0573-0180
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
ColorBROWN (butterscotch) Score no score
ShapeCAPSULE (oblong) Size14mm
FlavorImprint Code Advil;Cold;Sinus
Contains    
Packaging
#NDCPackage DescriptionMultilevel Packaging
10573-0180-102 BLISTER PACK In 1 CARTONcontains a BLISTER PACK
110 TABLET In 1 BLISTER PACKThis package is contained within the CARTON (0573-0180-10)
20573-0180-214 BLISTER PACK In 1 CARTONcontains a BLISTER PACK
210 TABLET In 1 BLISTER PACKThis package is contained within the CARTON (0573-0180-21)

Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA01977109/19/1989

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