Label: DUAL ACTION PAIN RELIEF- acetaminophen, ibuprofen tablet

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

Drug Label Information

Updated July 11, 2023

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  • Drug Facts

  • ACTIVE INGREDIENT

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

  • PURPOSE

    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 (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.

  • 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 docto
    • 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 20-25ºC (68-77ºF)
    • avoid excessive heat above 40°C (104°F)
  • INACTIVE INGREDIENT

    Inactive ingredients colloidal anhydrous silica, corn starch, croscarmellose sodium, glyceryl dibehenate, hypromellose, microcrystalline cellulose, polydextrose, povidone, red iron oxide, titanium dioxide, triacetin, yellow iron oxide.

  • QUESTIONS

    Questions or comments? Call 1-800-910-6874

  • PRINCIPAL DISPLAY PANEL

    716R-Target-Ibupara-72ct-IFC716R-Target-Ibupara-72ct-IFC

  • INGREDIENTS AND APPEARANCE
    DUAL ACTION PAIN RELIEF 
    acetaminophen, ibuprofen tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11673-924
    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
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    GLYCERYL DIBEHENATE (UNII: R8WTH25YS2)  
    POLYDEXTROSE (UNII: VH2XOU12IE)  
    POVIDONE (UNII: FZ989GH94E)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    TRIACETIN (UNII: XHX3C3X673)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    ColoryellowScoreno score
    ShapeCAPSULE (Capsule shaped tablet) Size15mm
    FlavorImprint Code 80
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:11673-924-751 in 1 CARTON07/11/2023
    172 in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA21699407/11/2023
    Labeler - TARGET CORPORATION (006961700)
    Registrant - TIME CAP LABORATORIES, INC. (037052099)
    Establishment
    NameAddressID/FEIBusiness Operations
    MARKSANS PHARMA LIMITED925822975manufacture(11673-924)
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