Advil Congestion Relief[Ibuprofen and Phenylephrine HCl]

ADVIL CONGESTION RELIEF - ibuprofen and phenylephrine hydrochloride tablet, film coated 
Pfizer Consumer Healthcare

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Advil Congestion Relief
[Ibuprofen and Phenylephrine HCl]

DRUG FACTS

ACTIVE INGREDIENTS (IN EACH TABLET)

Ibuprofen 200 mg (NSAID)*

Phenylephrine HCl 10 mg

* nonsteroidal anti-inflammatory drug

PURPOSES

Pain reliever/fever reducer

Nasal decongestant

USES

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:

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 right away.

DIRECTIONS

OTHER INFORMATION

INACTIVE INGREDIENTS

acesulfame potassium, artificial flavor, carnauba wax, colloidal silicon dioxide, corn starch, croscarmellose sodium, glycerin, hypromellose, lactic acid, lecithin, maltodextrin, medium-chain triglycerides, microcrystalline cellulose, pharmaceutical ink, polydextrose, polyvinyl alcohol, pregelatinized starch, propyl gallate, sodium lauryl sulfate , stearic acid, sucralose, synthetic iron oxide, talc, titanium dioxide, triacetin, xanthan gum

QUESTIONS OR COMMENTS?

Call weekdays from 9 AM to 5 PM toll free at 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.

CONTAINS: Ibuprofen & Phenylephrine

See new warnings information

Advil CONGESTION RELIEF

Ibuprofen 200 mg Pain Reliever/Fever Reducer (NSAID)

Phenylephrine HCl 10 mg Nasal Decongestant

NON-DROWSY relief of: Sinus Pressure, Nasal Swelling & Congestion, and Headache

1 PILL DOSAGE

20 COATED TABLETS

NON-DROWSY

Pfizer, Madison, NJ 07940 USA © 2010 Pfizer Inc.

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

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

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READ AND KEEP CARTON FOR COMPLETE WARNINGS AND INFORMATION

LIFT HERE For More Drug Facts

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ADVIL CONGESTION RELIEF 
ibuprofen, phenylephrine hcl   tablet, film coated
Product Information
Product TypeHUMAN OTC DRUGNDC Product Code (Source)0573-0195
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ibuprofen (ibuprofen) ibuprofen200 mg
phenylephrine hydrochloride (phenylephrine) phenylephrine hydrochloride10 mg
Inactive Ingredients
Ingredient NameStrength
acesulfame potassium 
carnauba wax 
colloidal silicon dioxide 
croscarmellose sodium 
ferrous oxide 
glycerin 
hypromelloses 
lactic acid 
lecithin, soybean 
maltodextrin 
medium-chain triglycerides 
polydextrose 
polyvinyl alcohol 
propyl gallate 
stearic acid 
sodium lauryl sulfate 
starch, corn 
sucralose 
talc 
titanium dioxide 
triacetin 
xanthan gum 
Product Characteristics
ColorBROWN (slightly, glossy tan) Score no score
ShapeOVAL (oval shaped tablet) Size15mm
FlavorImprint Code 1200;P10
Contains    
Packaging
#NDCPackage DescriptionMultilevel Packaging
10573-0195-101 BLISTER PACK In 1 CARTONcontains a BLISTER PACK
110 TABLET In 1 BLISTER PACKThis package is contained within the CARTON (0573-0195-10)
20573-0195-202 BLISTER PACK In 1 CARTONcontains a BLISTER PACK
210 TABLET In 1 BLISTER PACKThis package is contained within the CARTON (0573-0195-20)

Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA02256510/04/2010

Labeler - Pfizer Consumer Healthcare (828831730)
Establishment
NameAddressID/FEIOperations
Wyeth Pharmaceuticals Company, Consumer Site829390975MANUFACTURE, ANALYSIS, LABEL, PACK
Revised: 12/2010Pfizer Consumer Healthcare