Label: IBUPROFEN tablet

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

Drug Label Information

Updated May 19, 2018

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  • Active ingredient (in each tablet)

    Ibuprofen 200 mg (NSAID)*

    *nonsteroidal anti- inflammatory drug 

  • Purpose

    Pain Reliever/ Fever Reducer

  • Uses

    temporarily relieves minor aches and pain due to:

    • headache
    • toothache
    • backache
    • menstrual cramps
    • the common cold
    • muscular aches
    • minor pain of arthritis
    • 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 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 non prescription NSAIDs (aspirin, ibuprofen, naproxen, or others)
    • have 3 or more alcoholic drinks everyday while using this product
    • take more or for a longer time 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 or asthma
    • 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
    • the risk of heart attack or stroke may increase if you use more than directed or for longer than directed
  • 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
    • pain gets worse or last for more than 10 days
    • fever gets worse or last more than 3 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 during the last 3 months of 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). This Package for Households Without Young Children.

  • Directions

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

    adults and children
    12 years and older
    • take 1 tablet every4 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
    • consult a doctor

  • Other information

    • Tamper Evident: do not use if safety seal under cap is broken or missing
    • store at room temperature (20o- 25oC) 
    • avoid excessive heat above 40oC (104oF)
  • Inactive Ingredients:

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

  • Questions? Adverse drug event call: (866)562-2756 Mon-Fri: 8 AM to 4 PM

    *This product is not manufactured or distributed by Pfizer Consumer Products, owner of the registered trademark ADVIL®.

    Manufactured for:

    Pharbest Pharmaceuticals, Inc.,

    Farmingdale, NY 11735

    LRev 02/16

  • PRINCIPAL DISPLAY PANEL

    NDC 16103-0396-11

    PHARBEST

    *Compare to the active ingredient in Advil®

    Pain Reliever / Fever Reducer (NSAID)

    IBUPROFEN

    Tablets

    200mg

    1000 Tablets

    Pharbest Ibuprofen 200 mg Brown Tablet Product Label

  • INGREDIENTS AND APPEARANCE
    IBUPROFEN 
    ibuprofen tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:16103-396
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    IBUPROFEN (UNII: WK2XYI10QM) (IBUPROFEN - UNII:WK2XYI10QM) IBUPROFEN200 mg
    Inactive Ingredients
    Ingredient NameStrength
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    POLYETHYLENE GLYCOL 3350 (UNII: G2M7P15E5P)  
    POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    TALC (UNII: 7SEV7J4R1U)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    ColorbrownScoreno score
    ShapeROUNDSize10mm
    FlavorImprint Code 114
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:16103-396-111000 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product03/01/2016
    2NDC:16103-396-081 in 1 CARTON03/01/2016
    2100 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    3NDC:16103-396-061 in 1 CARTON03/01/2016
    350 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    4NDC:16103-396-041 in 1 CARTON03/01/2016
    430 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA09123903/01/2016
    Labeler - Pharbest Pharmaceuticals, Inc. (557054835)
    Registrant - Pharbest Pharmaceuticals, Inc. (557054835)
    Establishment
    NameAddressID/FEIBusiness Operations
    Pharbest Pharmaceuticals, Inc.557054835repack(16103-396) , relabel(16103-396)
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