Label: PROBUFEN- ibuprofen tablet

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated September 4, 2012

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  • ACTIVE INGREDIENT

    ACTIVE INGREDIENT: Ibuprophen 400mg

  • INACTIVE INGREDIENT

    Inactive ingredients:
    lactose, microcrystalline cellulose, magnesium stearate, Light Anhydrous Silicic Acid, titanium oxide, Talc, tar colorant, Hypromellose2910, Polyethylene Glycol, Ethanol, Methylene Chloride

  • PURPOSE

    PURPOSE: Pain reliever, Fever Reducer

  • DOSAGE AND ADMINISTRATION

    Direction
    1. Rheumatoid arthritis, osteoarthritis, ankylosing spondylitis, soft tissue injury, non-articular rheumatism, acute gout, psoriatic arthritis:
    200-600mg per dosage orally, 3~4 times a day as ibuprofen for adults.
    Maximum dosage is 3200mg per day.
    2. Juvenile rheumatoid arthiritis:
    30-40mg per kg of body weight divided into 3~4 portions per day orally.
    3. Mild and moderate pain, common cold:
    200-400mg per dosage orally, 3~4 times a day for adults.
    Appropriately increase or reduce dosage by age or symptom.
    4. Children should take the unit-dose below, 3~4 times a day orally.
    The dosage of children weighing less than 30kg should not exceed 500mg per day.
    It is advisable to avoid administering on an empty stomach.
    Unit-dose for children:
    11 - 14 yrs : 200 - 250 mg
    7 - 10 yrs : 150 - 200 mg
    3 - 6 yrs : 100 - 150 mg
    1 - 2 yrs : 50 - 100 mg

  • INDICATIONS AND USAGE

    Uses
    1. Major effects
    Fever and pain due to rheumatoid arthritis, juvenile rheumatoid arthritis, osteoarthritis (degenerative joint disease), common cold, back pain, dysmenorrhea, and post-operative pain.
    2. This can be used also for the following diseases.
    Ankylosing spondilytis, headache, toothache, myalgia, neuragia, acute gout, psoriatic arthritis, soft tissue injury (sprain, contusion), non-articular rheumatism (tendinitis, tendosynovitis, synovitis)

  • WARNINGS

    WARNING
    1. When those who drink alcohol over three glasses every day regularly with to take this drug or other antipyretic and analgesic, they must consult a doctor or pharmacist. Gastrointestinal bleeding may occur when these people take this drug.
    2. Cardiovascular risks: Administering non-steroidal anti-inflammatory drugs (NSAIDs) including this product may lead to severe cardiovascular thrombotic response, myocardial infaction, and stroke. The possibility of abnormal cardiovascular reaction increases in patients with a period. Adverse reactions should be carefully monitored while an adverse reaction occurs.
    3. Gastrointestinal risk: Administering NSAIDs including this product may cause severe gastrointestinal adverse reactions that may develop without any warning signs during the administration period. The risk of these adverse reactions increases in old age (elderly people) or in patients who have taken this drug for a long period.

  • KEEP OUT OF REACH OF CHILDREN

    KEEP OUT OF REACH OF CHILDREN

  • STORAGE AND HANDLING SECTION

    Other informations:
    Store in a hemetic container.
    Store between 1C to 30C

  • PACKAGE LABEL. PRINCIPAL DISPLAY PANEL

    Image of blister pack

  • INGREDIENTS AND APPEARANCE
    PROBUFEN 
    ibuprofen tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49789-050
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    IBUPROFEN (UNII: WK2XYI10QM) (IBUPROFEN - UNII:WK2XYI10QM) IBUPROFEN400 mg  in 537 mg
    Inactive Ingredients
    Ingredient NameStrength
    lactose (UNII: J2B2A4N98G)  
    magnesium stearate (UNII: 70097M6I30)  
    Talc (UNII: 7SEV7J4R1U)  
    Methylene Chloride (UNII: 588X2YUY0A)  
    Product Characteristics
    ColororangeScoreno score
    ShapeOVALSize15mm
    FlavorImprint Code SSP4
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:49789-050-01537 mg in 1 BLISTER PACK
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34312/01/2011
    Labeler - SAMSUNG PHARM IND. CO., LTD. (687744425)
    Registrant - SAMSUNG PHARM IND. CO., LTD. (687744425)
    Establishment
    NameAddressID/FEIBusiness Operations
    SAMSUNG PHARM IND. CO., LTD.687744425manufacture(49789-050)