Label: IBUPROFEN capsule, liquid filled

  • NDC Code(s): 25000-062-01, 25000-062-04, 25000-062-13, 25000-062-43, view more
    25000-062-67, 25000-062-69, 25000-062-87, 25000-133-01, 25000-133-04, 25000-133-13, 25000-133-18, 25000-133-23, 25000-133-43, 25000-133-69
  • Packager: MARKSANS PHARMA LIMITED
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated March 7, 2022

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

  • Active ingredient (in each capsule)

    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

  • Uses

    • temporarily relieves minor aches and pains due to:
    o headache
    o toothache
    o backache
    o menstrual cramps
    o the common cold
    o muscular aches
    o 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 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. 

    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

    • 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

    • 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, asthma, or had a stroke
    • 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
  • 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

    • you have symptoms of heart problems or stroke:
    • chest pain
    • trouble breathing
    • weakness in one part or side of body
    • slurred speech
    • leg swelling

    • 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 at 20 weeks or later in 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.

  • 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
  • Other information

    • each capsule contains: potassium 20 mg
    • read all warnings and directions before use. Keep carton.
    • store at 20-25ºC (68-77ºF)
    • 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, potassium hydroxide, propylene glycol, purified water, shellac, sorbitan monooleate, sorbitol sorbitan


  • Questions or comments?

    call toll free 1-877-376-4271

  • PRINCIPAL DISPLAY PANEL

     Ibuprofen capsules 200 mg (Liquid Filled Capsules)


    NDC 25000-133-43

    Ibuprofen capsules 200 mg (Liquid filled capsules)
    10's count bottle label


    ibu-10s-bott-labl


    NDC 25000-133-43

    Ibuprofen capsules 200 mg (Liquid filled capsules)
    10's count carton label


    ibu-10s-cart-labl


    NDC 25000-133-01

    Ibuprofen capsules 200 mg (Liquid filled capsules)
    20's count bottle label


    ibu-20s-bott-labl


    NDC 25000-133-01

    Ibuprofen capsules 200 mg (Liquid filled capsules)
    20's count carton label


    ibu-20s-cart-labl


    NDC 25000-133-04

    Ibuprofen capsules 200 mg (Liquid filled capsules)
    32's count bottle label


    ibu-32s-bott-labl


    NDC 25000-133-04

    Ibuprofen capsules 200 mg (Liquid filled capsules)
    32's count carton label


    ibu-32s-cart-labl


    NDC 25000-133-69

    Ibuprofen capsules 200 mg (Liquid filled capsules)
    300's count bottle label


    ibu-300s-bott-labl


    NDC 25000-133-13

    Ibuprofen capsules 200 mg (Liquid filled capsules)
    600's count bottle label


    ibu-600s-bott-labl


    Ibuprofen capsules 200 mg (Mini liquid filled capsules)

     

    NDC 25000-062-43

    Ibuprofen capsules 200 mg (Mini liquid filled capsules)
    10's count bottle label


    ibumini-10s-bott-labl


    NDC 25000-062-43

    Ibuprofen capsules 200 mg (Mini liquid filled capsules)
    10's count carton label


    ibumini-10s-cart-labl

     

    NDC 25000-062-01

    Ibuprofen capsules 200 mg (Mini liquid filled capsules)
    20's count bottle label


    ibumini-20s-bott-labl


    NDC 25000-062-01

    Ibuprofen capsules 200 mg (Mini liquid filled capsules)
    20's count carton label


    ibumini-20s-cart-labl


    NDC 25000-062-04

    Ibuprofen capsules 200 mg (Mini liquid filled capsules)
    32's count bottle label


    ibumini-32s-bott-labl


    NDC 25000-062-04

    Ibuprofen capsules 200 mg (Mini liquid filled capsules)
    32's count carton label


    ibumini-32s-cart-labl


    NDC 25000-062-67

    Ibuprofen capsules 200 mg (Mini liquid filled capsules)
    80's count bottle label


    ibumini-80s-bott-labl


    NDC 25000-062-67

    Ibuprofen capsules 200 mg (Mini liquid filled capsules)
    80's count carton label


    ibumini-80s-cart-labl


    NDC 25000-062-69

    Ibuprofen capsules 200 mg (Mini liquid filled capsules)
    300's count PET bottle label


    ibumini-300s-petbott-labl


    NDC 25000-062-13

    Ibuprofen capsules 200 mg (Mini liquid filled capsules)
    600's count bottle label


    ibumini-600s-bott-labl




     



  • INGREDIENTS AND APPEARANCE
    IBUPROFEN 
    ibuprofen capsule, liquid filled
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:25000-133
    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, UNSPECIFIED (UNII: 2G86QN327L)  
    SORBITOL (UNII: 506T60A25R)  
    WATER (UNII: 059QF0KO0R)  
    SHELLAC (UNII: 46N107B71O)  
    SORBITAN MONOOLEATE (UNII: 06XEA2VD56)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)  
    FERROUS OXIDE (UNII: G7036X8B5H)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    Product Characteristics
    ColorGREENScoreno score
    ShapeCAPSULESize19mm
    FlavorImprint Code 133
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:25000-133-235 in 1 DRUM09/01/2017
    12000 in 1 BAG; Type 0: Not a Combination Product
    2NDC:25000-133-184 in 1 BOX09/01/2017
    22500 in 1 BAG; Type 0: Not a Combination Product
    3NDC:25000-133-041 in 1 CARTON09/01/2017
    332 in 1 BOTTLE; Type 0: Not a Combination Product
    4NDC:25000-133-131 in 1 BOX09/01/2017
    4600 in 1 BOTTLE; Type 0: Not a Combination Product
    5NDC:25000-133-431 in 1 CARTON09/01/2017
    510 in 1 BOTTLE; Type 0: Not a Combination Product
    6NDC:25000-133-011 in 1 CARTON09/01/2017
    620 in 1 BOTTLE; Type 0: Not a Combination Product
    7NDC:25000-133-69300 in 1 BOTTLE; Type 0: Not a Combination Product09/01/2017
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA07920509/01/2017
    IBUPROFEN 
    ibuprofen capsule, liquid filled
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:25000-062
    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, UNSPECIFIED (UNII: 2G86QN327L)  
    SORBITOL (UNII: 506T60A25R)  
    WATER (UNII: 059QF0KO0R)  
    SHELLAC (UNII: 46N107B71O)  
    SORBITAN MONOOLEATE (UNII: 06XEA2VD56)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)  
    FERROUS OXIDE (UNII: G7036X8B5H)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    Product Characteristics
    ColorGREENScoreno score
    ShapeCAPSULESize6mm
    FlavorImprint Code 62
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:25000-062-431 in 1 CARTON08/18/2020
    110 in 1 BOTTLE; Type 0: Not a Combination Product
    2NDC:25000-062-0101 in 1 CARTON08/18/2020
    220 in 1 BOTTLE; Type 0: Not a Combination Product
    3NDC:25000-062-041 in 1 CARTON08/18/2020
    332 in 1 BOTTLE; Type 0: Not a Combination Product
    4NDC:25000-062-671 in 1 CARTON08/18/2020
    480 in 1 BOTTLE; Type 0: Not a Combination Product
    5NDC:25000-062-13600 in 1 BOTTLE; Type 0: Not a Combination Product08/18/2020
    6NDC:25000-062-871 in 1 BOX08/18/2020
    62500 in 1 BAG; Type 0: Not a Combination Product
    7NDC:25000-062-69300 in 1 BOTTLE; Type 0: Not a Combination Product11/25/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA07920508/18/2020
    Labeler - MARKSANS PHARMA LIMITED (925822975)
    Establishment
    NameAddressID/FEIBusiness Operations
    MARKSANS PHARMA LIMITED925822975MANUFACTURE(25000-062, 25000-133)