IBUPROFEN CAPSULE, LIQUID FILLED [BIONPHARMA INC.]

IBUPROFEN CAPSULE, LIQUID FILLED [BIONPHARMA INC.]
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NDC 69452-212-11, 69452-212-15, 69452-212-20, 69452-212-78, 69452-212-79, 69452-212-83
Set ID 4bc6e8f2-ba95-4352-80ed-b44608fc4936
Category HUMAN OTC DRUG LABEL
Packager Bionpharma Inc.
Generic Name
Product Class
Product Number
Application Number ANDA078682
  • 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 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 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 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.

  • 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
    • store at 20° to 25°C (68° to 77°F)
    • avoid excessive heat above 40°C (104°F). Protect from light.
  • Inactive ingredients

    FD&C Blue #1, gelatin, pharmaceutical ink, polyethylene glycol, potassium hydroxide, purified water, sorbitan and sorbitol

  • Questions or comments?

    call toll free 1-888-235-2466

    All trademarks are property of their respective owners. This product is not affiliated with the owners of Advil ® LIQUI-GELS ®

    DO NOT USE IF TAMPER-EVIDENT SEAL UNDER BOTTLE CAP IMPRINTED WITH “ SEALED for YOUR PROTECTION” IS BROKEN OR MISSING.

    Manufactured for:

    Bionpharma Inc.

    600 Alexander Road

    Princeton, NJ 08540

    Rev# 12/20

    L0000393

  • 360's Bottle Label

    100 Capsules

  • INGREDIENTS AND APPEARANCE
    IBUPROFEN 
    ibuprofen capsule, liquid filled
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69452-212
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    IBUPROFEN (UNII: WK2XYI10QM) (IBUPROFEN - UNII:WK2XYI10QM) IBUPROFEN200 mg
    Inactive Ingredients
    Ingredient NameStrength
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    GELATIN (UNII: 2G86QN327L)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)  
    WATER (UNII: 059QF0KO0R)  
    SORBITAN (UNII: 6O92ICV9RU)  
    SORBITOL (UNII: 506T60A25R)  
    Product Characteristics
    ColorblueScoreno score
    ShapeCAPSULESize20mm
    FlavorImprint Code IB200
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69452-212-1120 in 1 BOTTLE; Type 1: Convenience Kit of Co-Package11/01/201811/01/2018
    2NDC:69452-212-1540 in 1 BOTTLE; Type 1: Convenience Kit of Co-Package11/01/201811/01/2018
    3NDC:69452-212-7880 in 1 BOTTLE; Type 1: Convenience Kit of Co-Package11/01/201811/01/2018
    4NDC:69452-212-20100 in 1 BOTTLE; Type 1: Convenience Kit of Co-Package11/01/201811/01/2018
    5NDC:69452-212-79160 in 1 BOTTLE; Type 1: Convenience Kit of Co-Package11/01/201811/01/2018
    6NDC:69452-212-83300 in 1 BOTTLE; Type 0: Not a Combination Product11/01/201811/01/2018
    7NDC:69452-212-90360 in 1 BOTTLE; Type 0: Not a Combination Product02/04/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA07868211/01/2018
    Labeler - Bionpharma Inc. (079637826)
    Registrant - Bionpharma Inc. (079637826)
    Establishment
    NameAddressID/FEIBusiness Operations
    Patheon Softgels Inc.002193829manufacture(69452-212)

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