Label: ADVIL ALLERGY AND CONGESTION RELIEF- chlorpheniramine maleate, ibuprofen, and phenylephrine hydrochloride tablet, coated

  • NDC Code(s): 0573-0196-01, 0573-0196-02, 0573-0196-10, 0573-0196-20, view more
    0573-2161-03
  • Packager: Wyeth Consumer Healthcare LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: New Drug Application

Drug Label Information

Updated October 17, 2019

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

  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active ingredients
    (in each tablet)
    Purposes
    *
    nonsteroidal anti-inflammatory drug
    Chlorpheniramine maleate 4 mgAntihistamine
    Ibuprofen 200 mg (NSAID)*Pain reliever/Fever reducer
    Phenylephrine HCl 10 mgNasal 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 body aches and pains
      • fever
    • reduces swelling of the nasal passages
    • temporarily restores freer breathing through the nose
  • Warnings

    Allergy alert

    Ibuprofen may cause a severe allergic reaction, especially in people allergic to aspirin. Symptoms may include:

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

    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 because this product contains too much medication for children under this 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, have 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 phenylephrine, 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
    • may cause excitability especially in children

    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
    • pain gets worse or lasts more than 7 days
    • 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
    • adults and children 12 years of age and over:
      • take 1 tablet every 4 hours while symptoms persist
      • do not take more than 6 tablets in any 24-hour period, unless directed by a doctor
    • children under 12 years of age: do not use because this product contains too much medication for children under this age
  • 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

    acesulfame potassium, artificial flavors, carnauba wax, colloidal silicon dioxide, corn starch, croscarmellose sodium, glycerin, glycreyl dibehenate, hypromellose, lactic acid, lecithin, maltodextrin, medium-chain triglycerides, microcrystalline cellulose, pharmaceutical ink, polydextrose, polyvinyl alcohol, pregelatinized starch, propyl gallate, silicon dioxide, sucralose, synthetic iron oxide, talc, titanium dioxide, triacetin, xanthan gum

  • Questions or comments?

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

  • PRINCIPAL DISPLAY PANEL - 1 Tablet Packet

    TO OPEN: FOLD BACK ON DOTTED LINE.
    TEAR ON ARROW OR USE SCISSORS.
    Do Not Use if pouch is broken or torn.

    Advil®

    ALLERGY & CONGESTION RELIEF

    Chlorpheniramine Maleate 4 mg
    Antihistamine
    Ibuprofen 200 mg (NSAID)*
    Pain reliever/Fever reducer
    Phenylephrine HCl 10 mg
    Nasal decongestant

    1 Tablet

    *nonsteroidal anti-inflammatory drug

    PAA080418

    Principal Display Panel - 1 Tablet Packet
  • PRINCIPAL DISPLAY PANEL - 50 Packet Tray

    Advil®

    ALLERGY & CONGESTION RELIEF

    Chlorpheniramine Maleate 4 mg Antihistamine
    Ibuprofen 200 mg Pain Reliever/Fever Reducer
    (NSAID)
    Phenylephrine HCl 10 mg Nasal Decongestant

    1
    PILL
    DOSAGE

    Advil
    A&CR

    Relief of: Sinus Pressure, Nasal Swelling &
    Congestion, Sneezing, Runny Nose and Headache

    50 PACKETS OF 1 COATED TABLET

    PRINCIPAL DISPLAY PANEL - 50 Packet Tray
  • PRINCIPAL DISPLAY PANEL - 10 Tablet Blister Pack Carton

    Advil®

    ALLERGY &
    CONGESTION RELIEF

    Chlorpheniramine Maleate 4 mg Antihistamine
    Ibuprofen 200 mg Pain Reliever/Fever Reducer (NSAID)
    Phenylephrine HCl 10 mg Nasal Decongestant

    Advil
    A&CR

    ONE
    PILL
    DOSE!

    10
    Coated
    Tablets

    Sneezing
    Nasal Congestion
    Sinus Pressure
    Nasal Swelling
    Runny Nose
    Headache
    Fever
    Body Aches
    PRINCIPAL DISPLAY PANEL - 10 Tablet Blister Pack Carton
  • PRINCIPAL DISPLAY PANEL - 2 Tablet Packet Carton

    Advil®

    ALLERGY &
    CONGESTION RELIEF

    Chlorpheniramine Maleate 4 mg Antihistamine
    Ibuprofen 200 mg Pain Reliever/Fever Reducer (NSAID)
    Phenylephrine HCl 10 mg Nasal Decongestant

    Sneezing
    Nasal Congestion
    Sinus Pressure
    Nasal Swelling
    Runny Nose
    Headache
    Fever
    Body Aches

    ONE
    TABLET
    DOSE!

    2
    Packets of 1
    Coated Tablet

    PRINCIPAL DISPLAY PANEL - 2 Tablet Packet Carton
  • PRINCIPAL DISPLAY PANEL - 30 Tablet Blister Pack Carton

    50%
    MORE
    10 FREE
    Tablets

    Advil®

    ALLERGY &
    CONGESTION RELIEF

    Chlorpheniramine Maleate 4 mg Antihistamine
    Ibuprofen 200 mg Pain Reliever/Fever Reducer (NSAID)
    Phenylephrine HCl 10 mg Nasal Decongestant

    Sneezing
    Nasal Congestion
    Sinus Pressure
    Nasal Swelling
    Runny Nose
    Headache
    Fever
    Body Aches

    ONE
    TABLET
    DOSE!

    30
    Coated
    Tablets

    PRINCIPAL DISPLAY PANEL - 30 Tablet Blister Pack Carton
  • INGREDIENTS AND APPEARANCE
    ADVIL ALLERGY AND CONGESTION RELIEF 
    chlorpheniramine maleate, ibuprofen, and phenylephrine hydrochloride tablet, coated
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0573-0196
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CHLORPHENIRAMINE MALEATE (UNII: V1Q0O9OJ9Z) (CHLORPHENIRAMINE - UNII:3U6IO1965U) CHLORPHENIRAMINE MALEATE4 mg
    IBUPROFEN (UNII: WK2XYI10QM) (IBUPROFEN - UNII:WK2XYI10QM) IBUPROFEN200 mg
    PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE10 mg
    Inactive Ingredients
    Ingredient NameStrength
    ACESULFAME POTASSIUM (UNII: 23OV73Q5G9)  
    CARNAUBA WAX (UNII: R12CBM0EIZ)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    GLYCERYL DIBEHENATE (UNII: R8WTH25YS2)  
    HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
    LACTIC ACID, UNSPECIFIED FORM (UNII: 33X04XA5AT)  
    EGG PHOSPHOLIPIDS (UNII: 1Z74184RGV)  
    MALTODEXTRIN (UNII: 7CVR7L4A2D)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    POLYDEXTROSE (UNII: VH2XOU12IE)  
    POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990)  
    PROPYL GALLATE (UNII: 8D4SNN7V92)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    TALC (UNII: 7SEV7J4R1U)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    TRIACETIN (UNII: XHX3C3X673)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    Product Characteristics
    ColorGRAYScoreno score
    ShapeOVALSize17mm
    FlavorImprint Code Advil;A;CR
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0573-0196-0150 in 1 TRAY07/23/2012
    11 in 1 PACKET; Type 0: Not a Combination Product
    2NDC:0573-0196-101 in 1 CARTON07/23/2012
    210 in 1 BLISTER PACK; Type 0: Not a Combination Product
    3NDC:0573-0196-202 in 1 CARTON07/23/2012
    310 in 1 BLISTER PACK; Type 0: Not a Combination Product
    4NDC:0573-0196-022 in 1 CARTON10/01/2019
    41 in 1 PACKET; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    NDANDA02211307/23/2012
    ADVIL ALLERGY AND CONGESTION RELIEF 
    chlorpheniramine maleate, ibuprofen, and phenylephrine hydrochloride tablet, coated
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0573-2161
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CHLORPHENIRAMINE MALEATE (UNII: V1Q0O9OJ9Z) (CHLORPHENIRAMINE - UNII:3U6IO1965U) CHLORPHENIRAMINE MALEATE4 mg
    IBUPROFEN (UNII: WK2XYI10QM) (IBUPROFEN - UNII:WK2XYI10QM) IBUPROFEN200 mg
    PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE10 mg
    Inactive Ingredients
    Ingredient NameStrength
    ACESULFAME POTASSIUM (UNII: 23OV73Q5G9)  
    CARNAUBA WAX (UNII: R12CBM0EIZ)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    GLYCERYL DIBEHENATE (UNII: R8WTH25YS2)  
    HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
    LACTIC ACID, UNSPECIFIED FORM (UNII: 33X04XA5AT)  
    EGG PHOSPHOLIPIDS (UNII: 1Z74184RGV)  
    MALTODEXTRIN (UNII: 7CVR7L4A2D)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    POLYDEXTROSE (UNII: VH2XOU12IE)  
    POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990)  
    PROPYL GALLATE (UNII: 8D4SNN7V92)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    TALC (UNII: 7SEV7J4R1U)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    TRIACETIN (UNII: XHX3C3X673)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    Product Characteristics
    ColorGRAYScoreno score
    ShapeOVALSize17mm
    FlavorImprint Code Advil;A;CR
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0573-2161-032 in 1 CARTON10/01/2019
    110 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    NDANDA02211307/23/2012
    Labeler - Wyeth Consumer Healthcare LLC (828831730)
    Establishment
    NameAddressID/FEIBusiness Operations
    Wyeth Pharmaceuticals Company829390975ANALYSIS(0573-0196, 0573-2161) , LABEL(0573-0196, 0573-2161) , MANUFACTURE(0573-0196, 0573-2161) , PACK(0573-0196, 0573-2161)