Label: CLEAR CHOICE IBUPROFEN- ibuprofen tablet

  • Category: HUMAN OTC DRUG LABEL

Drug Label Information

Updated November 7, 2016

If you are a healthcare professional or from the pharmaceutical industry please visit this version.

  • Active ingredient (in each tablet)

    Ibuprofen USP, 200mg (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
    • 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 chances are 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 other pain reliever/fever reduce

    right before or after heart surgery

  • Ask a doctor before use if

    • the stomach bleeding warning applies to you
    • 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

    • taking aspirin to prevent heart attack or stroke, because ibuprofen may decrease this benefit of aspirin
    • under a doctor's care for any serious condition
    • 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
    • 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 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 20-25 degrees Celsius (68-77 degrees Fahrenheit).
    • Read all warnings and directions before use
    • Do not use if seal under bottle cap is broken or missing.
  • Inactive ingredients

    Anhydrous Lactose, Carnauba Wax, Colloidal Silicon Dioxide, Hypromellose, Iron Oxide Red, Magnesium Stearate, Microcrystalline Cellulose, Polydextrose, Polyethylene Glycol, Povidone, Sodium Lauryl Sulfate, Sodium Starch Glycolate, Starch (Corn), Titanium Dioxide

  • Questions or Comments

    Call 1-888-634-5522 Monday through Friday 9AM - 5PM EST.

  • Package Label

    Clear Choice

    IBUPROFEN

    MODERN PAIN MEDICINE

    PAIN AND FEVER RELIEF
    CONTAINS NO ASPIRIN
    CAFFEINE FREE

    Compare to Advil (R)

    100 Tablets
    200 mg each

    This product is not manufactured or distributed by Wyeth Consumer Healthcare, owner of the registered trademark Advil (R)

    Manufactured for: A.N.I. Toledo, OH 43623 CODE 27541

    Lot No.:

    Exp. Date:

    main label

    drug facts label

    drug facts label

  • INGREDIENTS AND APPEARANCE
    CLEAR CHOICE IBUPROFEN 
    ibuprofen tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53185-003
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    IBUPROFEN (UNII: WK2XYI10QM) (IBUPROFEN - UNII:WK2XYI10QM) IBUPROFEN200 mg
    Inactive Ingredients
    Ingredient NameStrength
    ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK)  
    CARNAUBA WAX (UNII: R12CBM0EIZ)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    POLYDEXTROSE (UNII: VH2XOU12IE)  
    POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A)  
    POVIDONES (UNII: FZ989GH94E)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    Colorbrown (brown) Scoreno score
    ShapeROUND (round) Size9mm
    FlavorImprint Code IBU200
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:53185-003-00100 in 1 BOTTLE; Type 0: Not a Combination Product06/03/2013
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA07912910/09/2012
    Labeler - Athlete's Needs Inc (619703945)
    Registrant - Athlete's Needs Inc (619703945)
    Establishment
    NameAddressID/FEIBusiness Operations
    Allegiant Health079501930manufacture(53185-003)