IBUPROFEN CAPSULE, LIQUID FILLED [J.P BUSINESS ENTERPRISE]

IBUPROFEN CAPSULE, LIQUID FILLED [J.P BUSINESS ENTERPRISE]
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NDC 59105-002-10
Set ID 5217f323-8847-425f-95b7-eecc84e558b1
Category HUMAN OTC DRUG LABEL
Packager J.P BUSINESS ENTERPRISE
Generic Name
Product Class
Product Number
Application Number ANDA079205
  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient (in each capsule)

    Solubilized ibuprofen equal to 200 mg ibuprofen (NSAID)1 (present as the free acid and potassium salt)


    1
    nonsteroidal anti-inflammatory drug
  • Purpose

    Pain reliever/fever reducer

  • Uses

    • temporarily relieves minor aches and pains 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 a nonsteroidal anti-inflammatory drug (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 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

    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

    • the stomach bleeding warning applies to you
    • you have problems or serious side effects from taking pain relievers or fever reducers
    • you have 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 lasts more than 10 days
      • fever gets worse or lasts more than 3 days
      • stomach pain or upset gets worse or lasts
      • 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)

  • Directions

    • do not take more than directed
    • the smallest effective dose should be used
    • do not take longer than 10 days, unless directed by a doctor (see Warnings)
    • adults and children 12 years and over: take 1 capsule every 4 to 6 hours while symptoms persist
      • if pain or fever does not respond to 1 capsule, 2 capsules may be used
      • do not exceed 6 capsules in 24 hours, unless directed by a doctor
    • children under 12 years: ask a doctor
  • Other information

    • each capsule contains: potassium 20 mg
    • read all warnings and directions before use. Keep carton.
    • store between 20°-25°C (68°-77°F)
    • avoid excessive heat above 40°C (104°F)
  • Inactive ingredients

    Ammonium hydroxide, FD&C green no. 3, Gelatin, Iron oxide black, Medium chain triglycerides, Polyethylene glycol, Propylene glycol, Potassium hydroxide, Purified water, Shellac, Sorbitan monooleate, Sorbitol sorbitan

  • Questions or comments?

    1-888-333-9792

  • SPL UNCLASSIFIED SECTION

    Distributed By: J.P Business Enterprise
    Lake Grove, NY 11755

  • PRINCIPAL DISPLAY PANEL - 10 Softgel Bottle Carton

    VALUMEDS

    SEE NEW WARNINGS INFORMATION

    Compare to the active ingredient
    in ADVIL® LIQUI-GELS®*

    IBUPROFEN softgels

    LIQUID FILLED IBUPROFEN CAPSULES, 200 mg

    PAIN RELIEVER/FEVER REDUCER (NSAID)

    10 SOFTGELS

    Principal Display Panel - 10 Softgel Bottle Carton
  • INGREDIENTS AND APPEARANCE
    IBUPROFEN 
    ibuprofen capsule, liquid filled
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59105-002
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    IBUPROFEN (UNII: WK2XYI10QM) (IBUPROFEN - UNII:WK2XYI10QM) IBUPROFEN200 mg
    Inactive Ingredients
    Ingredient NameStrength
    AMMONIA (UNII: 5138Q19F1X)  
    POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A)  
    GELATIN (UNII: 2G86QN327L)  
    FD&C GREEN NO. 3 (UNII: 3P3ONR6O1S)  
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    WATER (UNII: 059QF0KO0R)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)  
    SHELLAC (UNII: 46N107B71O)  
    SORBITAN MONOOLEATE (UNII: 06XEA2VD56)  
    Product Characteristics
    ColorGREENScoreno score
    ShapeOVALSize18mm
    FlavorImprint Code 133
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:59105-002-101 in 1 CARTON
    110 in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA07920508/20/2013
    Labeler - J.P BUSINESS ENTERPRISE (078775890)

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