Label: FLEX-PRIN- ibuprofen tablet

  • NDC Code(s): 69103-2525-5, 69103-2525-6
  • Packager: Provision Medical Products
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated January 5, 2023

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

  • INDICATIONS & USAGE

    Uses: temporarily relieves minor aches and pains due to:•headache • minor pain of arthritis • the common cold • toothache • backache • menstrual cramps • muscular aches • temporarily reduces fever

  • PREGNANCY OR BREAST FEEDING

    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 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.

  • WARNINGS

    Warnings:

    Allergy Alert: Ibuprofen may cause a severe allergic

    reaction which may include:

    • hives • shock • facial swelling • asthma (wheezing)

    Alcohol Warning: If you consume 3 or more alcoholic

    drinks every day, ask your doctor whether you should

    take Ibuprofen or other pain relievers/ fever reducers.

    Ibuprofen may cause stomach bleeding.

    Do not use:

    • if you have ever had an allergic reaction to any

    other pain reliever/fever reducer

    Ask a doctor before use if you have:

    • stomach pain

    • problems or serious side eects from taking

    pain relievers or fever reducers

    Ask a doctor or pharmacist before use if you are:

    • under a doctor's care for any serious condition

    • taking any other drug

    • taking any other product that contains Ibuprofen,

    or any other pain reliever/fever reducer

    When using this product give with food or milk if

    stomach upset occurs.

    Stop use and ask a doctor if:

    • an allergic reaction occurs. Seek medical help right

    away • pain gets worse or lasts more than 10 days

    • fever gets worse or lasts more than 3 days

    • stomach pain or upset gets worse or lasts

    • any new symptoms appear • redness or swelling is

    present in the painful area

  • DOSAGE & ADMINISTRATION

    Directions:

    • Do not take more than directed.

    Adults and children 12 years and older

    • Take 1  tablet every 4 to 6  hours while symptoms

    • If pain or fever does not respond to 1 tablet, 2 tablets may be used.

    Do not exceed 6 tablets in 24 hours, unless as directed by a doctor.

    • The smallest effective dose should be used.

    Children under 12 year

    • Ask a doctor.

  • INACTIVE INGREDIENT

    Inactive Ingredients:

    carnauba wax, croscarmellose sodium,

    hydroxypropyl methylcellulose,

    microcrystalline cellulose,

    polyethylene glycol, polysorbate 80,

    povidone, pregelatinized starch, silicon

    dioxide, sodium starch glycolate,

    stearic acid and titanium dioxide.

  • ACTIVE INGREDIENT

    ACTIVE INGREDIENT-IBUPROFEN 200 MG

  • PURPOSE

    PAIN RELIEVER/FEVER REDUCER

  • PRINCIPAL DISPLAY PANEL

    FLEX PRIN BOX

  • INGREDIENTS AND APPEARANCE
    FLEX-PRIN 
    ibuprofen tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69103-2525
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    IBUPROFEN (UNII: WK2XYI10QM) (IBUPROFEN - UNII:WK2XYI10QM) IBUPROFEN200 mg
    Inactive Ingredients
    Ingredient NameStrength
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    CARNAUBA WAX (UNII: R12CBM0EIZ)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    POVIDONE K30 (UNII: U725QWY32X)  
    STARCH, PREGELATINIZED CORN (UNII: O8232NY3SJ)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    TALC (UNII: 7SEV7J4R1U)  
    Product Characteristics
    ColorbrownScoreno score
    ShapeROUNDSize10mm
    FlavorImprint Code IBU200
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69103-2525-5250 in 1 CARTON04/05/2015
    12 in 1 PACKET; Type 0: Not a Combination Product
    2NDC:69103-2525-6100 in 1 CARTON04/05/2015
    22 in 1 PACKET; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA07912903/31/2015
    Labeler - Provision Medical Products (036936831)
    Registrant - Provision Medical Products (036936831)
    Establishment
    NameAddressID/FEIBusiness Operations
    Granules India Limited860316511manufacture(69103-2525)