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 September 22, 2023

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  • 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 at 20 weeks or later in 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

  • Additional Information

    READ AND KEEP CARTON FOR COMPLETE
    WARNINGS AND INFORMATION

    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.

    Dist. By: GSK Consumer Healthcare, Warren, NJ 07059

    Trademarks owned or licensed by GSK

    ©2020 GSK or licensor Patents: www.productpats.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

    Advil
    A/S

    20 COATED CAPLETS*

    *Capsule-Shaped Tablets

    PAA148681 Carton

    Advil Allergy and Sinus 20 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)
    Establishment
    NameAddressID/FEIBusiness Operations
    Wyeth Pharmaceuticals Company829390975ANALYSIS(0573-0188) , LABEL(0573-0188) , MANUFACTURE(0573-0188) , PACK(0573-0188)
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