Label: ADVIL ALLERGY SINUS- chlorpheniramine maleate, ibuprofen, pseudoephedrine hcl tablet, coated

  • NDC Code(s): 0573-0188-10
  • Packager: GlaxoSmithKline Consumer Healthcare Holdings (US) LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: New Drug Application

Drug Label Information

Updated November 11, 2020

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

  • ACTIVE INGREDIENTS (IN EACH CAPLET)

    Chlorpheniramine maleate 2 mg

    Ibuprofen 200 mg (NSAID)*

    Pseudoephedrine HCl 30 mg

    *nonsteroidal anti-inflammatory drug

  • PURPOSES

    Antihistamine

    Pain reliever/fever reducer

    Nasal decongestant

  • USES

    temporarily relieves these symptoms associated with hay fever or other upper respiratory allergies, and the common cold:

    runny nose
    itchy, watery eyes
    itching of the nose or throat
    sneezing
    nasal congestion
    sinus pressure
    headache
    minor aches and pains
    fever
  • 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

    Heart attack and stroke warning

    NSAIDs, except aspirin, increase the risk of heart attack, heart failure, and stroke. These can be fatal. The risk is higher if you use more than directed or for longer 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 a breathing problem such as emphysema or chronic bronchitis
    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, glaucoma, trouble urinating due to an enlarged prostate gland, or had a stroke
    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 sedatives or tranquilizers
    taking any other product that contains pseudoephedrine, chlorpheniramine or any other nasal decongestant or antihistamine
    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
    avoid alcoholic drinks
    be careful when driving a motor vehicle or operating machinery
    drowsiness may occur
    alcohol, sedatives, and tranquilizers may increase drowsiness

    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
    you have symptoms of heart problems or stroke:
    chest pain
    trouble breathing
    weakness in one part or side of body
    slurred speech
    leg swelling
    fever gets worse or lasts more than 3 days
    nasal congestion lasts for more than 7 days
    redness or swelling is present in the painful area
    you get nervous, dizzy, or sleepless
    symptoms continue or get worse
    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

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

    read all warnings and directions before use. Keep carton.
    store at 20-25°C (68-77°F)
    avoid excessive heat above 40°C (104°F)
  • INACTIVE INGREDIENTS

    carnauba wax, colloidal silicon dioxide, corn starch, croscarmellose sodium, FD&C red no. 40 aluminum lake, FD&C yellow no. 6 aluminum lake, glyceryl behenate, hypromellose, microcrystalline cellulose, pharmaceutical ink, polydextrose, polyethylene glycol, pregelatinized starch, silicon dioxide, titanium dioxide

  • QUESTIONS OR COMMENTS?

    Call weekdays from 9 AM to 5 PM EST at 1-800-88-ADVIL

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

  • PRINCIPAL DISPLAY PANEL

    Advil®

    ALLERGY SINUS

    Ibuprofen 200 mg ➤ Pain Reliever/Fever Reducer (NSAID)
    Pseudoephedrine HCl 30 mg ➤ Nasal Decongestant
    Chlorpheniramine Maleate 2 mg ➤ Antihistamine

    Relieves Runny Nose, Nasal Congestion, Sneezing,
    Itchy, Watery Eyes, Headache and Sinus Pressure

    ONLY
    1
    PILL
    EVERY
    4-6
    HOURS

    20
    COATED
    CAPLETS*

    *Capsule-Shaped Tablets

    PRINCIPAL DISPLAY PANEL - 20 Tablet Blister Pack Carton
  • INGREDIENTS AND APPEARANCE
    ADVIL ALLERGY SINUS 
    chlorpheniramine maleate, ibuprofen, pseudoephedrine hcl tablet, coated
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0573-0188
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CHLORPHENIRAMINE MALEATE (UNII: V1Q0O9OJ9Z) (CHLORPHENIRAMINE - UNII:3U6IO1965U) CHLORPHENIRAMINE MALEATE2 mg
    IBUPROFEN (UNII: WK2XYI10QM) (IBUPROFEN - UNII:WK2XYI10QM) IBUPROFEN200 mg
    PSEUDOEPHEDRINE HYDROCHLORIDE (UNII: 6V9V2RYJ8N) (PSEUDOEPHEDRINE - UNII:7CUC9DDI9F) PSEUDOEPHEDRINE HYDROCHLORIDE30 mg
    Inactive Ingredients
    Ingredient NameStrength
    CARNAUBA WAX (UNII: R12CBM0EIZ)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    GLYCERYL DIBEHENATE (UNII: R8WTH25YS2)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    POLYDEXTROSE (UNII: VH2XOU12IE)  
    HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    Product Characteristics
    ColorORANGE (bright orange) Scoreno score
    ShapeOVAL (oval shaped tablet) Size15mm
    FlavorImprint Code Advil;A;S
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0573-0188-1020 in 1 CARTON12/20/2002
    11 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    NDANDA02144112/20/2002
    Labeler - GlaxoSmithKline Consumer Healthcare Holdings (US) LLC (079944263)
    Registrant - Pfizer Inc (113480771)
    Establishment
    NameAddressID/FEIBusiness Operations
    Wyeth Pharmaceuticals Company829390975ANALYSIS(0573-0188) , LABEL(0573-0188) , MANUFACTURE(0573-0188) , PACK(0573-0188)