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Pill Identifier Information of Ibuprofen 200 MG Oral Tablet

Drug Information

Ibuprofen 200 MG Oral Tablet

Imprint: 200mg
Shape: C48348
Color: C48325
Ingredients: Ibuprofen
Size: 10.00
Score: 1
Rxtty: SCD
Author: A P J Laboratories Limited
Inactive Ingredients: CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS / STARCH, CORN / GELATIN / METHYLPARABEN / TITANIUM DIOXIDE / MAGNESIUM STEARATE / TALC / SODIUM STARCH GLYCOLATE TYPE A POTATO / SILICON DIOXIDE>

Complete Information

  • ACTIVE INGREDIENT

    Ibuprofen USP, 200 mg (NSAID)
  • PURPOSE

    Pain reliever/fever reducer

  • 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 (1-800-222-1222) right away.
  • INDICATIONS & USAGE

    temporarily relieves minor aches and pains due to:

    headache
    muscular aches
    minor pain of arthritis
    toothache
    backache
    the common cold
    menstrual cramps
    temporarily reduces fever


  • 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 a nonsteroidal anti-inflammatory drug (NSAID), which may cause severe stomach bleeding. The chances are 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


  • DOSAGE & ADMINISTRATION

    do not take more than directed

    the smallest effective dose should be used

     
    Adults and children 12 years and older: take 1 tablet every 4 to 6 hours while symptoms persist

    if pain or fever does not respond to 1 tablet, 2 tablets may be used

    do not exceed 6 tablets in 24 hours, unless directed by a doctor
     
    Children under 12 years: ask a doctor

  • INACTIVE INGREDIENT



    CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS
  • INACTIVE INGREDIENT

    STARCH, CORN
  • INACTIVE INGREDIENT


    GELATIN
  • INACTIVE INGREDIENT


    METHYLPARABEN
  • INACTIVE INGREDIENT

    TITANIUM DIOXIDE
  • INACTIVE INGREDIENT


    MAGNESIUM STEARATE

  • INACTIVE INGREDIENT

    TALC
  • INACTIVE INGREDIENT

    SODIUM STARCH GLYCOLATE TYPE A POTATO
  • INACTIVE INGREDIENT


    SILICON DIOXIDE
  • PRINCIPAL DISPLAY PANEL

    product

  • INGREDIENTS AND APPEARANCE
    APROFEN  REGULAR STRENGTH
    ibuprofen tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:46084-021
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    IBUPROFEN (UNII: WK2XYI10QM) (IBUPROFEN - UNII:WK2XYI10QM) IBUPROFEN200 mg
    Inactive Ingredients
    Ingredient NameStrength
    CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: L11K75P92J) 40 mg
    STARCH, CORN (UNII: O8232NY3SJ) 20 mg
    GELATIN (UNII: 2G86QN327L) 2 mg
    METHYLPARABEN (UNII: A2I8C7HI9T) 3 mg
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) 0.1 mg
    MAGNESIUM STEARATE (UNII: 70097M6I30) 10 mg
    TALC (UNII: 7SEV7J4R1U) 10 mg
    SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2) 20 mg
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4) 1 mg
    Product Characteristics
    ColorwhiteScoreno score
    ShapeROUNDSize10mm
    FlavorImprint Code 200mg
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:46084-021-26500 in 1 BLISTER PACK
    2NDC:46084-021-24250 in 1 BLISTER PACK
    3NDC:46084-021-23100 in 1 BLISTER PACK
    4NDC:46084-021-2250 in 1 BLISTER PACK
    5NDC:46084-021-312 in 1 BLISTER PACK
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34302/21/2013
    Labeler - A P J Laboratories Limited (677378339)
    Registrant - A P J Laboratories Limited (677378339)
    Establishment
    NameAddressID/FEIBusiness Operations
    A P J Laboratories Limited677378339manufacture(46084-021)