Label: ADVIL COLD AND SINUS- ibuprofen and pseudoephedrine hydrochloride tablet, coated

  • NDC Code(s): 0573-0180-10, 0573-0180-21
  • Packager: Pfizer Consumer Healthcare
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: New Drug Application

NOTE: Most over the counter (OTC) are not reviewed and approved by the FDA. However, they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated 02/12

If you are a consumer or patient please visit this version.

  • DRUG FACTS
  • ACTIVE INGREDIENTS (IN EACH CAPLET)

    Ibuprofen 200 mg (NSAID)*

    Pseudoephedrine HCl 30 mg

    *nonsteroidal anti-inflammatory drug

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  • PURPOSES

    Pain reliever/fever reducer

    Nasal decongestant

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  • USES

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

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

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  • DIRECTIONS

    • do not take more than directed
    • the smallest effective dose should be used
    • adults and children 12 years of age and over:
      • take 1 caplet every 4 to 6 hours while symptoms persist. If symptoms do not respond to 1 caplet, 2 caplets may be used.
      • do not use more than 6 caplets in any 24-hour period unless directed by a doctor
    • children under 12 years of age: do not use
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  • OTHER INFORMATION

    • 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.
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  • 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

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  • QUESTIONS OR COMMENTS?

    Call toll free 1-800-88-ADVIL

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  • 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
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  • INGREDIENTS AND APPEARANCE
    ADVIL COLD AND SINUS 
    ibuprofen, pseudoephedrine hcl tablet, coated
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:0573-0180
    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
    Inactive Ingredients
    Ingredient Name Strength
    CARNAUBA WAX  
    SILICON DIOXIDE  
    STARCH, CORN  
    CROSCARMELLOSE SODIUM  
    METHYLPARABEN  
    CELLULOSE, MICROCRYSTALLINE  
    SHELLAC  
    POVIDONE  
    SODIUM BENZOATE  
    SODIUM LAURYL SULFATE  
    STEARIC ACID  
    SUCROSE  
    TITANIUM DIOXIDE  
    PROPYLPARABEN  
    Product Characteristics
    Color BROWN (butterscotch) Score no score
    Shape CAPSULE (oblong) Size 14mm
    Flavor Imprint Code Advil;Cold;Sinus
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:0573-0180-10 2 in 1 CARTON
    1 10 in 1 BLISTER PACK
    2 NDC:0573-0180-21 4 in 1 CARTON
    2 10 in 1 BLISTER PACK
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    NDA NDA019771 09/19/1989
    Labeler - Pfizer Consumer Healthcare (828831730)
    Establishment
    Name Address ID/FEI Business Operations
    Wyeth Pharmaceuticals Company, Consumer Site 829390975 MANUFACTURE(0573-0180), ANALYSIS(0573-0180), LABEL(0573-0180), PACK(0573-0180)
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