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Name:Advil Cold And Sinus
Manufacturer:Wyeth Consumer Healthcare
Category:Over-the-counter (OTC) Marketed Drugs

ADVIL COLD & SINUS(ibuprofen and pseudoephedrine HCl)

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


(ibuprofen and pseudoephedrine HCl)



Solubilized ibuprofen equal to 200 mg ibuprofen (NSAID)*

(present as the free acid and potassium salt)

Pseudoephedrine HCl 30 mg

*nonsteroidal anti-inflammatory drug


Pain reliever/fever reducer

Nasal decongestant


temporarily relieves these symptoms associated with the common cold or flu:

  • headache
  • fever
  • sinus pressure
  • nasal congestion
  • minor body aches and pains


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 a nonsteroidal anti-inflammatory drug (NSAID), which may cause 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 an NSAID [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 you have

  • problems or serious side effects from taking pain relievers or fever reducers
  • stomach problems that last or come back, such as heartburn, upset stomach, or stomach pain
  • ulcers
  • bleeding problems
  • high blood pressure
  • heart or kidney disease
  • asthma
  • thyroid disease
  • diabetes
  • trouble urinating due to an enlarged prostate gland
  • taken a diuretic
  • reached age 60 or older

Ask a doctor or pharmacist before use if you are

  • taking any other drug containing a NSAID (prescription or nonprescription)
  • taking a blood thinning (anticoagulant) or steroid drug
  • 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 feel faint, vomit blood, or have bloody or black stools. These are signs of stomach bleeding.
  • fever gets worse or lasts more than 3 days
  • nasal congestion lasts for more than 7 days
  • symptoms continue or get worse
  • stomach pain or upset gets worse or lasts
  • 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.


  • do not take more than directed
  • the smallest effective dose should be used
  • do not take longer than 7 days, unless directed by a doctor (see WARNINGS)
  • adults and children 12 years of age and over:
    • take 1 capsule every 4 to 6 hours while symptoms persist. If symptoms do not respond to 1 capsule, 2 capsules may be used.
    • do not use more than 6 capsules in any 24-hour period unless directed by a doctor
  • children under 12 years of age: do not use


  • each capsule contains: potassium 20 mg
  • store at 20-25°C (68-77°F). Avoid excessive heat above 40°C (104°F).
  • read all warnings and directions before use. Keep carton.


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


call toll-free 1-800-88-ADVIL


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

Advil COLD & SINUS Liqui-Gels


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

Pseudoephedrine HCl 30 mg >> Nasal Decongestant

Relieves Sinus Pressure, Nasal Congestion and Fever



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

Distributed by: Wyeth Consumer Healthcare

Madison, NJ 07940 USA ©2009 Wyeth

U.S. Patent Pending

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

Advil COLD & SINUS Liqui-Gels Packaging

ibuprofen, pseudoephedrine hcl capsule, liquid filled
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:0573-0184
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ibuprofen (ibuprofen) ibuprofen 200 mg
pseudoephedrine hydrochloride (pseudoephedrine) pseudoephedrine hydrochloride 30 mg
Product Characteristics
Color ORANGE (light orange to light yellow with a slight orange hue) Score no score
Shape OVAL (oval softgel) Size 15mm
Flavor Imprint Code Advil;C;S;with;black;ink
# Item Code Package Description Multilevel Packaging
1 NDC:0573-0184-32 1 BLISTER PACK ( BLISTER PACK) in 1 CARTON contains a BLISTER PACK
1 32 CAPSULE, LIQUID FILLED ( CAPSULE) in 1 BLISTER PACK This package is contained within the CARTON (0573-0184-32)

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA021374 05/30/2002

Labeler - Wyeth Consumer Healthcare (828831730)

Revised: 02/2010 Wyeth Consumer Healthcare

Reproduced with permission of U.S. National Library of Medicine

Copyright © 2020 by Dionisios Fentas || Terms of Use


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