Label: EQUATE IBUPROFEN- ibuprofen capsule, liquid filled

  • NDC Code(s): 49035-133-12, 49035-133-14, 49035-133-18, 49035-133-26
  • Packager: Walmart stores Inc
  • Category: HUMAN OTC DRUG LABEL

Drug Label Information

Updated July 1, 2014

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

  • ACTIVE INGREDIENT(S)

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

    *nonsteroidal anti-inflammatory drug

  • PURPOSE

    Pain reliever/Fever reducer

  • USE(S)

    • 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:

    Ibuprofenmay 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 anallergic reaction occurs, stop use and seek medical help right away.

    Stomach bleeding warning:

    Thisproduct contains an NSAID, which may cause severe stomach bleeding. The chanceis 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 a history of 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

    • 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 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
  • OTHER REQUIRED WARNINGS

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

    Ask a health professional before use. It is especiallyimportant not to use ibuprofen during the last 3 months of pregnancy unlessdefinitely directed to do so by a doctor because it may cause problems in theunborn 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 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
  • INACTIVE INGREDIENT(S)

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

  • PRINCIPAL DISPLAY PANEL

    NDC 49035-133-12

    equateTM

    Ibuprofen

    Capsules, 200mg

    Pain Reliever/ Fever Reducer

    (NSAID)

    200mg, 20 SOFTGELS

    Liquid-Filled Capsules


    ibu-sfgels-20ct


    ibu-sfgels-20ct


    ibu-sfgels-20ct




    NDC 49035-133-14

    equateTM

    Ibuprofen

    Capsules, 200mg

    Pain Reliever/ Fever

    Reducer (NSAID)

    Liquid-Filled Capsules

    200mg, 40 SOFTGELS



    ibu-sfgels-40ct


    ibu-sfgels-40ct


    ibu-sfgels-40ct



    NDC 49035-133-18

    equateTM

    Ibuprofen

    Capsules, 200mg

    Pain Reliever/ Fever 

    Reducer (NSAID)

    Liquid-Filled Capsules

    200mg, 80 SOFTGELS



    ibu-sfgels-80ct


    ibu-sfgels-80ct


    NDC 49035-133-26

    equateTM

    Ibuprofen

    Capsules, 200mg

    Pain Reliever/ Fever 

    Reducer (NSAID)

    Liquid-Filled Capsules

    200mg, 160 SOFTGELS




    ibu-sfgels-160ct


    ibu-sfgels-160ct
  • INGREDIENTS AND APPEARANCE
    EQUATE IBUPROFEN 
    ibuprofen capsule, liquid filled
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49035-133
    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)  
    FD&C GREEN NO. 3 (UNII: 3P3ONR6O1S)  
    GELATIN (UNII: 2G86QN327L)  
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)  
    WATER (UNII: 059QF0KO0R)  
    SHELLAC (UNII: 46N107B71O)  
    SORBITAN MONOOLEATE (UNII: 06XEA2VD56)  
    SORBITOL (UNII: 506T60A25R)  
    SORBITAN (UNII: 6O92ICV9RU)  
    Product Characteristics
    ColorGREENScoreno score
    ShapeCAPSULESize19mm
    FlavorImprint Code 133
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:49035-133-1220 in 1 BOTTLE
    2NDC:49035-133-1440 in 1 BOTTLE
    3NDC:49035-133-1880 in 1 BOTTLE
    4NDC:49035-133-26160 in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA07920507/02/2014
    Labeler - Walmart stores Inc (051957769)
    Establishment
    NameAddressID/FEIBusiness Operations
    Marksans Pharma Limited925822975MANUFACTURE(49035-133)