Label: IBUPROFEN CA- ibuprofen tablet, coated

  • NDC Code(s): 11673-990-20, 11673-990-42
  • Packager: TARGET CORPORATION
  • Category: HUMAN OTC DRUG LABEL

Drug Label Information

Updated January 3, 2024

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  • ACTIVE INGREDIENT

    Active ingredient (in each caplet)

    Ibuprofen 200 mg (NSAID)*

    * nonstreoidal anti-inflammatory drug

  • PURPOSE

    Purpose

    Pain reliever / fever reducer

  • INDICATIONS & USAGE

    Uses

    temporarily relieves minor aches and pains due to:

    • headache
    • toothache
    • backache
    • menstrual cramps
    • the common cold
    • muscular aches
    • minor pain of arthritis

    temporarily reduces fever

  • WARNINGS

    Warnings

    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.

    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

    • if you have ever had an allergic reaction to any other pain reliever/fever reducer
    • right before or after heart surgery

    Ask a doctor before use if

    • 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, 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
    fever gets worse or lasts more than 3 days
    redness or swelling is present in the painful area

    any new symptoms appear

  • PREGNANCY OR BREAST FEEDING

    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

    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)

  • STORAGE AND HANDLING

    Other information

    • read all warnings and directions before use
    • store at 20-25ºC (68-77ºF)
  • DOSAGE & ADMINISTRATION

    Directions

    • do not take more than directed
    • the smallest effective dose should be used

    adults and children 12 years and over: take 1 caplet every 4 to 6 hours while symptoms persist

    if pain or fever does not respond to 1 caplet, 2 caplets may be used
    do not exceed 6 caplets in 24 hours, unless directed by a doctor

    children under 12 years: ask a doctor

  • INACTIVE INGREDIENT

    Inactive ingredients colloidal silicon dioxide, croscarmellose sodium, iron oxide red, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, pregelatinized starch, talc, titanium dioxide

  • QUESTIONS

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

  • PRINCIPAL DISPLAY PANEL

    600R-TG-200s-label600R-TG-200s-ifc24CT

  • INGREDIENTS AND APPEARANCE
    IBUPROFEN CA 
    ibuprofen tablet, coated
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11673-990
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    IBUPROFEN (UNII: WK2XYI10QM) (IBUPROFEN - UNII:WK2XYI10QM) IBUPROFEN200 mg
    Inactive Ingredients
    Ingredient NameStrength
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    TALC (UNII: 7SEV7J4R1U)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    ColorbrownScoreno score
    ShapeCAPSULE ((CAPLET)) Size15mm
    FlavorImprint Code 117
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:11673-990-4224 in 1 BOTTLE; Type 0: Not a Combination Product01/01/2020
    2NDC:11673-990-20200 in 1 BOTTLE; Type 0: Not a Combination Product01/01/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA09123901/01/2020
    Labeler - TARGET CORPORATION (006961700)
    Registrant - TIME CAP LABORATORIES, INC (037005209)
    Establishment
    NameAddressID/FEIBusiness Operations
    MARKSANS PHARMA LTD925822975manufacture(11673-990)
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