Label: ADVIL DUAL ACTION WITH ACETAMINOPHEN- ibuprofen, acetaminophen tablet, film coated

  • NDC Code(s): 0573-0147-18, 0573-0147-36, 0573-0147-72, 0573-0147-86, view more
    0573-0147-94, 0573-0147-95
  • Packager: GlaxoSmithKline Consumer Healthcare Holdings (US) LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: New Drug Application

Drug Label Information

Updated October 1, 2021

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

  • Active ingredients (in each caplet)

    Acetaminophen 250 mg

    Ibuprofen 125 mg (NSAID*)

    *nonsteroidal anti-inflammatory drug

  • Purposes

    Pain reliever

    Pain reliever

  • INDICATIONS & USAGE

    Uses

    temporarily relieves minor aches and pains due to:
    headache
    toothache
    backache
    menstrual cramps
    muscular aches
    minor pain of arthritis
  • WARNINGS

    Warnings

    Acetaminophen liver damage warning:

    This product contains acetaminophen. Severe liver damage may occur if you take:

    with other drugs containing acetaminophen
    more than 6 caplets in 24 hours, which is the maximum daily amount for this product
    3 or more alcoholic drinks every day while using this product

    Acetaminophen allergy alert: may cause severe skin reactions. Symptoms may include:

    skin reddening
    blisters
    rash

    If skin reaction occurs, stop use and seek medical help right away.

    NSAID 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.

    NSAID 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

    with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist
    if you have ever had an allergic reaction to acetaminophen or any other pain reliever
    right before or after heart surgery

    Ask a doctor before use if

    you have liver disease
    stomach bleeding warning applies to you
    you have problems or serious side effects from taking pain relievers
    you have a history of stomach problems, such as heartburn
    you have high blood pressure, heart disease, liver cirrhosis, kidney disease, asthma, 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 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

    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 10 days
    redness or swelling is present in the painful area
    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. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

  • DOSAGE & ADMINISTRATION

    Directions

    do not take more than directed

    adults and children

    12 years and over

    take 2 caplets every 8 hours while symptoms persist

    children under 12 years

    ask a doctor
    do not take more than 6 caplets in 24 hours, unless directed by a doctor
  • STORAGE AND HANDLING

    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 INGREDIENT

    Inactive ingredients

    carnauba wax, colloidal silicon dioxide, croscarmellose sodium, ferric oxides, glyceryl dibehenate, hypromellose, pharmaceutical ink, polydextrose, polyethylene glycol, pregelatinized starch, titanium dioxide

  • QUESTIONS

    Questions or comments?

    call weekdays 9 AM to 5 PM at 1-800-88-ADVIL

  • PRINCIPAL DISPLAY PANEL

    NDC 0573-0147-94
    Advil
    DUAL ACTION
    WITH Acetaminophen

    Acetaminophen 250 mg and
    Ibuprofen (NSAID) 125 mg Tablets
    Pain Reliever

    144
    Caplets*
    *Capsule-Shaped Tablets

    000067297 Front Carton

    Advil Dual Action Capsule-Shaped Tablets 144ct Carton
  • INGREDIENTS AND APPEARANCE
    ADVIL DUAL ACTION WITH ACETAMINOPHEN 
    ibuprofen, acetaminophen tablet, film coated
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0573-0147
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    IBUPROFEN (UNII: WK2XYI10QM) (IBUPROFEN - UNII:WK2XYI10QM) IBUPROFEN125 mg
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN250 mg
    Inactive Ingredients
    Ingredient NameStrength
    CARNAUBA WAX (UNII: R12CBM0EIZ)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    GLYCERYL DIBEHENATE (UNII: R8WTH25YS2)  
    HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
    POLYDEXTROSE (UNII: VH2XOU12IE)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    ColorYELLOWScoreno score
    ShapeOVALSize15mm
    FlavorImprint Code Advil;II
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0573-0147-181 in 1 CARTON07/27/2020
    118 in 1 BOTTLE; Type 0: Not a Combination Product
    2NDC:0573-0147-361 in 1 CARTON07/27/2020
    236 in 1 BOTTLE; Type 0: Not a Combination Product
    3NDC:0573-0147-721 in 1 CARTON07/27/2020
    372 in 1 BOTTLE; Type 0: Not a Combination Product
    4NDC:0573-0147-861 in 1 CARTON07/27/2020
    4216 in 1 BOTTLE; Type 0: Not a Combination Product
    5NDC:0573-0147-941 in 1 CARTON07/27/2020
    5144 in 1 BOTTLE; Type 0: Not a Combination Product
    6NDC:0573-0147-9550 in 1 CARTON07/27/2020
    62 in 1 POUCH; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    NDANDA21173307/27/2020
    Labeler - GlaxoSmithKline Consumer Healthcare Holdings (US) LLC (079944263)
    Establishment
    NameAddressID/FEIBusiness Operations
    Wyeth Pharmaceuticals Company829390975ANALYSIS(0573-0147) , LABEL(0573-0147) , MANUFACTURE(0573-0147) , PACK(0573-0147)