Label: IBUPROFEN- ibuprofen tablet, film coated

  • NDC Code(s): 21130-393-12, 21130-393-14, 21130-393-15
  • Packager: Better Living Brands, LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated June 12, 2017

If you are a consumer or patient please visit this version.

  • Active ingredient (in each orange caplet)

    Ibuprofen USP,
    200 mg (NSAID)*
    *nonsteroidal anti-inflammatory drug

    Close
  • Purpose

    Pain reliever/fever reducer

    Close
  • Uses

    • temporarily relieves minor aches and pains due to:
      • minor pain or arthritis
      • headache
      • toothache
      • backache
      • menstrual cramps
      • the common cold
      • muscular aches
    • temporarily reduces fever 
    Close
  • 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:

    • take more or for a longer time than directed
    • take a blood thinning (anticoagulant) or steroid drug
    • are age 60 or older
    • take other drugs containing prescription or nonprescription NSAIDs [aspirin, ibuprofen, naproxen, or others]
    • have had stomach ulcers or bleeding problems
    • have 3 or more alcoholic drinks every day while using this product

    Heart attack and stroke warning: NSAIDs, except aspirin, increase the risk of heart attack, heart failure, and stroke. These can be fatal. The risk is higher if you use more than directed or for longer than directed.

    Do not use

    • right before or after heart surgery
    • if you have ever had an allergic reaction to any other pain reliever/fever reducer

    Ask a doctor before use if

    • stomach bleeding warning applies to you
    • you have a history of stomach problems, such as heartburn
    • you are taking a diuretic
    • you have high blood pressure, heart disease, liver cirrhosis, kidney disease,asthma, or had a stroke
    • you have problems or serious side effects from taking pain relievers or fever reducers

    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

    Stop use and ask a doctor if

    • you experience any of the following signs of stomach bleeding:
      • vomit blood
      • feel faint
      • have bloody or black stools
      • have stomach pain that does not get better
    • you have symptoms of heart problems or stroke
      • chest pain
      • trouble breathing
      • leg swelling
      • slurred speech
      • weakness in one part or side of body
    • 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 complication during delivery.

    Keep out of reach of children

    In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

    Close
  • Directions

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

    • store between 20º-25ºC (68º-77ºF)
    • avoid excessive heat 40ºC (104ºF)
    • see end flap for expiration date and lot number
    Close
  • Inactive ingredients

    carnauba wax, colloidal silicon dioxide, corn starch, FD&C yellow #6 aluminum lake, hypromellose, lactose anhydrous, magnesium stearate, microcrystalline cellulose, polydextrose, polyethylene glycol, sodium starch glycolate, stearic acid, titanium dioxide

    Close
  • Questions or comments?

     Call 1-800-426-9391 8:30 AM-4:00 PM ET, Monday-Friday

    Close
  • Principal Display Panel

    Signature™
    care
    Quality Guaranteed

    COMPARE TO Motrin® IB Caplets active ingredient†

    NDC 21130-393-15

    Ibuprofen
    IBUPROFEN TABLETS USP, 200 mg
    Pain Reliever /
    Fever Reducer
    (NSAID)

    Actual Size

    50 CAPLETS

    TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

    †This product is not manufactured or distributed by Johnson & Johnson Corporation, distributors of Motrin® IB Caplets.

    50844       REV1116A39315

    DISTRIBUTED BY BETTER LIVING BRANDS LLC
    P.O. BOX 99, PLEASANTON, CA 94566-0009
    1-888-723-3929 www.betterlivingbrandsLLC.com
    QUALITY & SATISFACTION 100% GUARANTEED OR YOUR
    MONEY BACK

    RD 17045
    Signature Care 44-393

    Signature Care 44-393


    Close
  • INGREDIENTS AND APPEARANCE
    IBUPROFEN 
    ibuprofen tablet, film coated
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:21130-393
    Route of Administration ORAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    IBUPROFEN (UNII: WK2XYI10QM) (IBUPROFEN - UNII:WK2XYI10QM) IBUPROFEN 200 mg
    Inactive Ingredients
    Ingredient Name Strength
    CARNAUBA WAX (UNII: R12CBM0EIZ)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    POLYDEXTROSE (UNII: VH2XOU12IE)  
    POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A)  
    SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    Color ORANGE Score no score
    Shape OVAL Size 14mm
    Flavor Imprint Code 44;393
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:21130-393-12 1 in 1 CARTON 03/01/1999
    1 100 in 1 BOTTLE; Type 0: Not a Combination Product
    2 NDC:21130-393-15 1 in 1 CARTON 03/01/1999
    2 50 in 1 BOTTLE; Type 0: Not a Combination Product
    3 NDC:21130-393-14 500 in 1 BOTTLE; Type 0: Not a Combination Product 03/01/1999
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    ANDA ANDA075139 03/01/1999
    Labeler - Better Living Brands, LLC (009137209)
    Establishment
    Name Address ID/FEI Business Operations
    LNK International, Inc. 038154464 PACK(21130-393)
    Establishment
    Name Address ID/FEI Business Operations
    LNK International, Inc. 832867894 MANUFACTURE(21130-393)
    Close