Label: ACETAMINOPHEN AND IBUPROFEN- acetaminophen, ibuprofen tablet, film coated

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

Drug Label Information

Updated June 1, 2023

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  • Active ingredients (in each caplet)

    Acetaminophen 250 mg

    Ibuprofen 125 mg (NSAID*)

    *nonsteroidal anti-inflammatory drug

  • Purposes

    Pain reliever

  • Uses

    •
    temporarily relieves minor aches and pains due to:
    •
    headache
    •
    toothache
    •
    backache
    •
    menstrual cramps
    •
    muscular aches
    •
    minor pain of arthritis
  • 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 (1-800-222-1222). Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

  • 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
  • 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

    colloidal silicon dioxide, corn starch, croscarmellose sodium, crospovidone, ferric oxide yellow, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, pregelatinized starch, stearic acid, sucralose, talc, titanium dioxide

  • Questions or comments?

    1-800-632-6900

  • Package/Label Principal Display Panel

    COMPARE TO the active ingredients of ADVIL® DUAL ACTION

    See side panel

    CONTAINS 2 MEDICINES

    Kroger®

    DUAL ACTION

    OUR PHARMACIST RECOMMENDED

    Acetaminophen + Ibuprofen Tablets

    ACTUAL SIZE

    Acetaminophen 250 mg & Ibuprofen (NSAID) 125 mg Tablets

    72 CAPLETS‡

    Pain Reliever

    ‡Capsule-Shaped Tablets

    acetaminophen and ibuprofen tablets-image 1
    acetaminophen and ibuprofen tablets-image 2
  • INGREDIENTS AND APPEARANCE
    ACETAMINOPHEN AND IBUPROFEN 
    acetaminophen, ibuprofen tablet, film coated
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:30142-720
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN250 mg
    IBUPROFEN (UNII: WK2XYI10QM) (IBUPROFEN - UNII:WK2XYI10QM) IBUPROFEN125 mg
    Inactive Ingredients
    Ingredient NameStrength
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    CROSPOVIDONE, UNSPECIFIED (UNII: 2S7830E561)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990)  
    POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    TALC (UNII: 7SEV7J4R1U)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    ColorYELLOWScoreno score
    ShapeOVALSize14mm
    FlavorImprint Code I;I
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:30142-720-231 in 1 CARTON05/16/2023
    172 in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA21483605/16/2023
    Labeler - Kroger Company (006999528)
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