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

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: New Drug Application

Drug Label Information

Updated May 21, 2021

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

  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active ingredients (in each caplet)Purposes
    *
    nonsteroidal anti-inflammatory drug
    Acetaminophen 250 mgPain reliever
    Ibuprofen 125 mg (NSAID *) 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 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.

  • 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

    Advil Dual Action

  • INGREDIENTS AND APPEARANCE
    ADVIL DUAL ACTION WITH ACETAMINOPHEN 
    ibuprofen, acetaminophen tablet, film coated
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:67751-211(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:67751-211-011 in 1 CARTON05/21/2021
    12 in 1 POUCH; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    NDANDA21173305/21/2021
    Labeler - Navajo Manufacturing Company Inc. (091917799)
    Establishment
    NameAddressID/FEIBusiness Operations
    Navajo Manufacturing Company Inc.136941411relabel(67751-211) , repack(67751-211)