VALUMEDS IBUPROFEN (IBUPROFEN) TABLET, FILM COATED [SPIRIT PHARMACEUTICALS LLC]

VALUMEDS IBUPROFEN (IBUPROFEN) TABLET, FILM COATED [SPIRIT PHARMACEUTICALS LLC]
PDF | XML

NDC 68210-0800-1, 68210-0800-4
Set ID a6d4ceb0-2b79-496a-aa1e-27edd507ced0
Category HUMAN OTC DRUG LABEL
Packager SPIRIT PHARMACEUTICALS LLC
Generic Name
Product Class
Product Number
Application Number ANDA091239
  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient (in each tablet)

    Ibuprofen 200 mg (NSAID)

  • 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

    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
  • 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 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

    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 over: 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

    • read all warnings and directions before use
    • store between 20°-25°C (68°-77°F)
    • avoid excessive heat above 40°C (104°F)
  • Inactive ingredients

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

  • Questions or comments?

    1-888-333-9792

  • SPL UNCLASSIFIED SECTION

    Distributed By

    Spirit Pharmaceuticals, LLC

    Ronkonkoma, NY 11779

  • PRINCIPAL DISPLAY PANEL- 200 mg 100 ct Bottle

    VALUMEDS

    IBUPROFEN

    TABLETS USP, 200MG

    PAIN RELEIVER/FEVER REDUCER (NSAID)


    100 TABLETS

    (COATED BROWN)

    image description

  • INGREDIENTS AND APPEARANCE
    VALUMEDS IBUPROFEN 
    ibuprofen tablet, film coated
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68210-0800
    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)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    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:68210-0800-1100 in 1 BOTTLE; Type 0: Not a Combination Product05/19/2017
    2NDC:68210-0800-41 in 1 CARTON04/11/2018
    240 in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA09123905/19/2017
    Labeler - SPIRIT PHARMACEUTICALS LLC (179621011)
    Establishment
    NameAddressID/FEIBusiness Operations
    MARKSANS PHARMA LTD925822975manufacture(68210-0800)

Related Drugs