IBUPROFEN SOFTGELS (IBUPROFEN) CAPSULE [BREEDEN BROTHERS, LLC]

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IBUPROFEN SOFTGELS (IBUPROFEN) CAPSULE [BREEDEN BROTHERS, LLC]
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NDC 70729-000-01, 70729-000-02, 70729-509-32
Set ID 1fa232d5-1997-49b2-bf4f-361652e50a6e
Category HUMAN OTC DRUG LABEL
Packager Breeden Brothers, LLC
Generic Name
Product Class
Product Number
Application Number ANDA206568
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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient (in each capsule)

    Solubilized ibuprofen equal to Pain reliever/ 200 mg ibuprofen (NSAID)* 

    *nonsteroidal anti-inflammatory drug

  • Purpose

    fever reducer (present as the free acid and potassium salt)

    Drug Facts (continued)

  • Uses

    _ temporarily relieves minor aches and pains due to:

    _ muscular aches

    _ the common cold

    _ headache

    _ toothache

    _ backache

    _ menstrual cramps

    _ 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:

    _ blisters

    _ rash

    _ hives

    _ asthma (wheezing)

    _ shock

    _ skin reddening

    _ facial swelling

    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 a blood thinning (anticoagulant) or

    Drug Facts (continued)

    steroid drug

    _ are age 60 or older

    _ have had stomach ulcers or bleeding problems

    _ 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

    _ stomach bleeding warning applies to you

    _ you have a history of stomach problems, such as heartburn

    _ you are taking a diuretic

    Drug Facts (continued)

    _ you have high blood pressure, heart disease, liver cirrhosis, kidney disease or asthma

    _ you have problems or serious side effects from taking pain relievers or fever reducers

    Ask a doctor or pharmacist before use if you are

    _ taking any other drug

    _ under a doctor's care for any serious condition

    _ taking aspirin for heart attack or stroke, because ibuprofen may decrease this benefit of aspirin

    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 a doctor if

    _ you experience any of the following signs of

    Drug Facts (continued)

    stomach bleeding:

    _ feel faint

    _ have stomach pain that does not get better

    _ have bloody or black stools

    _ vomit blood

    _ 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. (1-800-222-1222)

    Drug Facts (continued)

  • 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 28 mg

    _ read all warnings and directions before use.

    _ store at 20°-25°C (68°-77°F)

    _ avoid excessive heat above 40°C (104°F)

    Drug Facts (continued)

  • Inactive ingredients

    FD&C green #3, gelatin, isopropyl alcohol, medium chain triglycerides, polyethylene glycol, potassium hydroxide, purified water, sorbitol special, and white edible ink

  • Questions or comments?

    1-800-901-2420

    Product of China

  • PRINCIPAL DISPLAY PANEL

    b+b
    better by giving
    IBUPROFEN
    SOFTGELS
    20 Softgels
    (200 mg each)

    PRINCIPAL DISPLAY PANEL b+b better by giving IBUPROFEN SOFTGELS 20 Softgels (200 mg each)

  • PRINCIPAL DISPLAY PANEL

    b+b
    better by giving
    IBUPROFEN
    SOFTGELS
    40 Softgels
    (200 mg each)

    PRINCIPAL DISPLAY PANEL b+b better by giving IBUPROFEN SOFTGELS 40 Softgels (200 mg each)

  • PRINCIPAL DISPLAY PANEL

    NDC 70729-509-32
    b+b
    IBUPROFEN
    SOFTGELS
    120 Softgels
    (200 mg each)

    PRINCIPAL DISPLAY PANEL NDC 70729-509-32 b+b IBUPROFEN SOFTGELS 120 Softgels (200 mg each)

  • INGREDIENTS AND APPEARANCE
    IBUPROFEN SOFTGELS 
    ibuprofen capsule
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70729-000
    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 GREEN NO. 3 (UNII: 3P3ONR6O1S)  
    GELATIN (UNII: 2G86QN327L)  
    ISOPROPYL ALCOHOL (UNII: ND2M416302)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A)  
    POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)  
    WATER (UNII: 059QF0KO0R)  
    SORBITOL (UNII: 506T60A25R)  
    Product Characteristics
    ColorGREENScoreno score
    ShapeCAPSULESize18mm
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70729-000-0120 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product02/01/2018
    2NDC:70729-000-0240 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product02/01/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA20656802/01/2018
    IBUPROFEN SOFTGELS 
    ibuprofen capsule
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70729-509
    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 GREEN NO. 3 (UNII: 3P3ONR6O1S)  
    GELATIN (UNII: 2G86QN327L)  
    ISOPROPYL ALCOHOL (UNII: ND2M416302)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A)  
    POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)  
    WATER (UNII: 059QF0KO0R)  
    SORBITOL (UNII: 506T60A25R)  
    Product Characteristics
    ColorGREENScoreno score
    ShapeCAPSULESize18mm
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70729-509-32120 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product02/01/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA20656802/01/2018
    Labeler - Breeden Brothers, LLC (080131046)
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