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

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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:

  • hives
  • facial swelling
  • asthma (wheezing)
  • shock
  • skin reddening
  • rash
  • blisters

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:

  • are age 60 or older
  • have had stomach ulcers or bleeding problems
  • take a blood thinning (anticoagulant) or steroid drug
  • take other drugs containing prescription or nonprescription NSAIDs [aspirin, ibuprofen, naproxen, or others]
  • have 3 or more alcoholic drinks every day while using this product
  • take more or for a longer time than directed

Do not use

  • in children under 12 years of age
  • if you have ever had an allergic reaction to any other pain reliever/fever reducer
  • right before or after heart surgery
  • if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.

Ask a doctor before use if

  • stomach bleeding warning applies to you
  • you have problems or serious side effects from taking pain relievers or fever reducers
  • you have a history of stomach problems, such as heartburn
  • you have high blood pressure, heart disease, liver cirrhosis, kidney disease, asthma, thyroid disease, diabetes or have trouble urinating due to an enlarged prostate gland
  • you are taking a diuretic

Ask a doctor or pharmacist before use if you are

  • under a doctor’s care for any serious condition
  • taking any other product that contains pseudoephedrine or any other nasal decongestant
  • taking aspirin for heart attack or stroke, because ibuprofen may decrease this benefit of aspirin
  • taking any other drug

When using this product

  • take with food or milk if stomach upset occurs
  • the risk of heart attack or stroke may increase if you use more than directed or for longer than directed

Stop use and ask a doctor if

  • you experience any of the following signs of stomach bleeding:
    • feel faint
    • vomit blood
    • have bloody or black stools
    • have stomach pain that does not get better
  • fever gets worse or lasts more than 3 days
  • nasal congestion lasts for more than 7 days
  • symptoms continue or get worse
  • redness or swelling is present in the painful area
  • you get nervous, dizzy, or sleepless
  • any new symptoms appear

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

Non-Drowsy

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

Pseudoephedrine HCl 30 mg >> Nasal Decongestant

Relieves Sinus Pressure, Nasal Congestion and Fever

20 COATED CAPLETS*

*Oval-Shaped Tablets

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.

READ AND KEEP CARTON FOR COMPLETE WARNINGS AND INFORMATION

Advil COLD & SINUS Packaging

ADVIL COLD AND SINUS 
ibuprofen, pseudoephedrine hcl tablet, coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: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
carnauba wax 
cellulose, microcrystalline 
croscarmellose sodium 
methylparaben 
povidone 
propylparaben 
shellac 
silicon dioxide 
sodium benzoate 
sodium lauryl sulfate 
starch, corn 
stearic acid 
sucrose 
titanium dioxide 
Product Characteristics
ColorBROWN (butterscotch) Score no score
ShapeCAPSULE (oblong) Size14mm
FlavorImprint Code Advil;Cold;Sinus
Contains    
Packaging
#Item CodePackage DescriptionMultilevel Packaging
1NDC:0573-0180-102 BLISTER PACK ( BLISTER PACK) in 1 CARTONcontains a BLISTER PACK
110 TABLET, COATED ( TABLET) in 1 BLISTER PACKThis package is contained within the CARTON (0573-0180-10)
2NDC:0573-0180-214 BLISTER PACK ( BLISTER PACK) in 1 CARTONcontains a BLISTER PACK
210 TABLET, COATED ( 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 - Pfizer Consumer Healthcare (828831730)
Establishment
NameAddressID/FEIOperations
Wyeth Pharmaceuticals Company, Consumer Site829390975MANUFACTURE, ANALYSIS, LABEL, PACK

Revised: 06/2011 Pfizer Consumer Healthcare