Label: IBUPROFEN capsule, liquid filled

  • NDC Code(s): 59556-764-11, 59556-764-12, 59556-764-13, 59556-764-18, view more
    59556-764-29, 59556-764-48, 59556-764-49, 59556-764-50, 59556-764-92, 59556-895-13, 59556-895-29, 59556-895-39, 59556-895-48, 59556-895-50, 59556-895-79, 59556-895-85, 59556-895-86, 59556-895-87, 59556-895-88
  • Packager: Strides Pharma Inc
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated April 15, 2024

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:
      • headache
      • toothache
      • backache
      • menstrual cramps
      • the common cold
      • muscular aches
      • 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 an NSAID, which may cause severe stomach bleeding. The chance is higher if you

    • are aged 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

    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 17.840 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)
  • Inactive ingredients

    Ibuprofen Capsules

    FD&C blue 1, gelatin, gelatin (hydrolyzed), medium chain triglyceride, PEG 600, potassium hydroxide, purified water, sorbital and sorbitan solution.

    Printing ink: propylene glycol, shellac resins, sodium lauryl sulphate, titanium dioxide.

    Ibuprofen Capsules – Minis

    FD&C green no.3, gelatin, gelatin (hydrolyzed), lecithin (Soya Lecithin), medium chain triglyceride, polyethylene Glycol 600, potassium hydroxide, purified water, sorbital and sorbitan solution.

    Printing ink: propylene glycol, shellac resins, sodium lauryl sulphate, titanium dioxide.

  • Questions or comments?

    call toll free 1-877-244-9825

    Do Not Use if seal under bottle cap imprinted with "SEALED for YOUR PROTECTION" is broken or missing.

    For most recent product information, visit us at www.strides.com

    Revised: 05/2023

    Manufactured by:

    Strides Pharma Science Limited

    Bengaluru - 562106, India

    Distributed by:

    Strides Pharma Inc.

    East Brunswick, NJ 08816

  • PRINCIPAL DISPLAY PANELS

    Ibuprofen Capsules, 200 mg Pain Reliever/Fever Reducer (NSAID)

    Liquid Filled Capsules

    160s count
    Ibuprofen carton label
    80s count

    Ibuprofen Capsules, 200 mg Pain Reliever/Fever Reducer (NSAID)

    Liquid Filled Capsules - Minis

    Ibuprofen minis carton label
    80s count minis
    160s count minis
  • INGREDIENTS AND APPEARANCE
    IBUPROFEN 
    ibuprofen capsule, liquid filled
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59556-764
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    IBUPROFEN (UNII: WK2XYI10QM) (IBUPROFEN - UNII:WK2XYI10QM) IBUPROFEN200 mg
    Inactive Ingredients
    Ingredient NameStrength
    POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)  
    POLYETHYLENE GLYCOL 600 (UNII: NL4J9F21N9)  
    WATER (UNII: 059QF0KO0R)  
    GELATIN (UNII: 2G86QN327L)  
    SORBITOL (UNII: 506T60A25R)  
    SORBITAN (UNII: 6O92ICV9RU)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    SHELLAC (UNII: 46N107B71O)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    ColorGREEN (transparent green to bluish green) Scoreno score
    ShapeOVAL (oblong shaped) Size8mm
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:59556-764-291 in 1 CARTON11/16/2022
    120 in 1 BOTTLE; Type 0: Not a Combination Product
    2NDC:59556-764-121 in 1 CARTON11/16/2022
    240 in 1 BOTTLE; Type 0: Not a Combination Product
    3NDC:59556-764-131 in 1 CARTON11/16/2022
    380 in 1 BOTTLE; Type 0: Not a Combination Product
    4NDC:59556-764-111 in 1 CARTON11/16/2022
    4120 in 1 BOTTLE; Type 0: Not a Combination Product
    5NDC:59556-764-481 in 1 CARTON11/16/2022
    5160 in 1 BOTTLE; Type 0: Not a Combination Product
    6NDC:59556-764-491 in 1 CARTON11/16/2022
    6200 in 1 BOTTLE; Type 0: Not a Combination Product
    7NDC:59556-764-501 in 1 CARTON11/16/2022
    7300 in 1 BOTTLE; Type 0: Not a Combination Product
    8NDC:59556-764-181 in 1 CARTON11/16/2022
    8180 in 1 BOTTLE; Type 0: Not a Combination Product
    9NDC:59556-764-923000 in 1 BAG; Type 0: Not a Combination Product11/16/2022
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA20446911/16/2022
    IBUPROFEN 
    ibuprofen capsule, liquid filled
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59556-895
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    IBUPROFEN (UNII: WK2XYI10QM) (IBUPROFEN - UNII:WK2XYI10QM) IBUPROFEN200 mg
    Inactive Ingredients
    Ingredient NameStrength
    POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)  
    POLYETHYLENE GLYCOL 600 (UNII: NL4J9F21N9)  
    WATER (UNII: 059QF0KO0R)  
    GELATIN (UNII: 2G86QN327L)  
    SORBITOL (UNII: 506T60A25R)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    SHELLAC (UNII: 46N107B71O)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    FD&C GREEN NO. 3 (UNII: 3P3ONR6O1S)  
    LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
    SORBITAN (UNII: 6O92ICV9RU)  
    Product Characteristics
    ColorGREEN (transparent green to bluish green) Scoreno score
    ShapeOVALSize8mm
    FlavorImprint Code 469
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:59556-895-291 in 1 CARTON11/16/2022
    120 in 1 BOTTLE; Type 0: Not a Combination Product
    2NDC:59556-895-131 in 1 CARTON11/16/2022
    280 in 1 BOTTLE; Type 0: Not a Combination Product
    3NDC:59556-895-481 in 1 CARTON11/16/2022
    3160 in 1 BOTTLE; Type 0: Not a Combination Product
    4NDC:59556-895-501 in 1 CARTON11/16/2022
    4300 in 1 BOTTLE; Type 0: Not a Combination Product
    5NDC:59556-895-797000 in 1 BAG; Type 0: Not a Combination Product11/16/2022
    6NDC:59556-895-851 in 1 CARTON11/16/2022
    680 in 1 BOTTLE; Type 0: Not a Combination Product
    7NDC:59556-895-861 in 1 CARTON11/16/2022
    7120 in 1 BOTTLE; Type 0: Not a Combination Product
    8NDC:59556-895-871 in 1 CARTON11/16/2022
    8160 in 1 BOTTLE; Type 0: Not a Combination Product
    9NDC:59556-895-391 in 1 CARTON11/16/2022
    9200 in 1 BOTTLE; Type 0: Not a Combination Product
    10NDC:59556-895-881 in 1 CARTON11/16/2022
    10300 in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA20446911/16/2022
    Labeler - Strides Pharma Inc (078868278)