IBUPROFEN TABLET, COATED [AVEMA PHARMA SOLUTIONS]

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IBUPROFEN TABLET, COATED [AVEMA PHARMA SOLUTIONS]
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NDC 63548-0234-1, 63548-0234-2, 63548-0234-3
Set ID 1662a495-4f6a-4515-a405-557681e1a496
Category HUMAN OTC DRUG LABEL
Packager PLD Acquisitions LLC DBA Avéma Pharma Solutions
Generic Name
Product Class
Product Number
Application Number ANDA076460
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  • Active ingredient (in each tablet)

    Ibuprofen USP, 200 mg (NSAID)*

    *nonsteroidal anti-inflammatory drug

    Purpose

    Pain reliever/fever reducer

  • Uses

    • 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
    • rash
    • blisters
    • skin reddening

    If an allergic reaction occurs, stop use an seek medical help right away.

    Stomach bleeding warning: This product contains an NSAID which may cause sever 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)
    • take more or for a longer time than directed
    • have 3 or more alcoholic drinks every day while using this product

    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, or kidney disease
    • you have 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
      • have bloody or black stools  
      • vomit blood
      • have stomach pain that does not get better
    • pain gets worse or last more than 10 days
    • fever gets worse or last more than 3 days
    • redness or swelling is present 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).

  • Directions

    • 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
  • Other information

    • store between 20º-25ºC (68º-77ºF)
  • Inactive ingredients

    carnauba wax, croscarmellose sodium, FD&C yellow# 6 aluminium lake, hypromellose, microcrystalline cellulose, polydextrose, polyethylene glycol, pregelatinized starch, silicon dioxide, stearic acid, titanium dioxide

  • Questions or comments?

    Call 1-877-753-3935 Monday-Friday 9AM-5PM EST 

  • Principal Display Panel

    Ibuprofen

    Tablets USP, 200 mg

    Pain Reliever/ Fever Reducer (NSAID)

    Coated Tablets

    DO NOT USE IF IMPRINTED SAFETY SEAL UNDER BOTTLE CAP IMPRINTED WITH "SEALED FOR YOUR PROTECTION" IS BROKEN OR MISSING.

    KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION

    Manufactured by: Avema Pharma Solution

    10400 NW 29th terrace

    Miami, FL 33172

  • Product Label

    Avema Pharma Solutions

    Ibuprofen 200 mg tablets

    Avema Pharma Solutions

    Ibuprofen 200 mg tablets

    Avema Pharma Solutions

    Ibuprofen 200 mg orange tablet

    Avema Pharma Solutions

    Ibuprofen 200 mg orange tablet

  • INGREDIENTS AND APPEARANCE
    IBUPROFEN 
    ibuprofen tablet, coated
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63548-0234
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    IBUPROFEN (UNII: WK2XYI10QM) (IBUPROFEN - UNII:WK2XYI10QM) IBUPROFEN200 mg
    Inactive Ingredients
    Ingredient NameStrength
    CARNAUBA WAX (UNII: R12CBM0EIZ)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    POLYDEXTROSE (UNII: VH2XOU12IE)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    ColorORANGEScoreno score
    ShapeROUNDSize9mm
    FlavorImprint Code 52
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:63548-0234-21 in 1 BOX08/01/2013
    1100 in 1 BOTTLE; Type 0: Not a Combination Product
    2NDC:63548-0234-110 in 1 VIAL; Type 0: Not a Combination Product08/01/2013
    3NDC:63548-0234-31000 in 1 BOTTLE; Type 0: Not a Combination Product08/01/2013
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA07646008/01/2013
    Labeler - PLD Acquisitions LLC DBA Avéma Pharma Solutions (804087794)
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