Label: MICONAZOLE NITRATE- miconazole nitrate suppository

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated 09/12

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

  • OTC - ACTIVE INGREDIENT SECTION

    Miconazole nitrate 100 mg

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  • OTC - PURPOSE SECTION

    Vaginal Antifungal

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  • INDICATIONS & USAGE SECTION

    Use
    • treats vaginal yeast infections

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  • WARNINGS SECTION

    WARNINGS
    For vaginal use only

    Do not use
    if you have never had a vaginal yeast infection diagnosed by a doctor

    Ask a doctor before use if you have
    • vaginal itching and discomfort for the first time
    • lower abdominal, back or shoulder pain, fever, chills, nausea, vomiting, or foul-smelling vaginal discharge
    • vaginal yeast infections often (such as once a month or 3 in 6 months). You could be pregnant or have a serious underlying medical cause for your symptoms, including diabetes or a weakened immune system.
    • been exposed to the human immunodeficiency virus (HIV) that causes AIDS

    Ask a doctor or pharmacist before use if you are taking the prescription blood thinning medicine warfarin, because bleeding or bruising may occur.

    When using this product
    • do not use tampons, douches, spermicides, or other vaginal products. Condoms and diaphragms may be damaged by this product and fail to prevent pregnancy or sexually transmitted diseases (STDs).
    • do not have vaginal intercourse

    Stop use and ask a doctor if
    • symptoms do not get better in 3 days
    • symptoms last more than 7 days
    • you get a rash, abdominal pain, fever, chills, nausea, vomiting, or foul-smelling vaginal discharge
    • In case of accidental ingestion, seek professional assistance or contact a poison control center immediately.

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  • OTC - PREGNANCY OR BREAST FEEDING SECTION

    If pregnant or breast-feeding, ask a health professional before use

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  • OTC - KEEP OUT OF REACH OF CHILDREN SECTION

    Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

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  • DOSAGE & ADMINISTRATION SECTION

    Directions
    • before using this product, read the enclosed brochure for complete instructions
    • adults and children 12 years of age and over:
          • insert 1 suppository into the vagina at bedtime for 7 nights in a row  
          • wash applicator after each use
    • children under 12 years of age: ask a doctor

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  • STORAGE AND HANDLING SECTION

    • store at 15°-30°C (59°-86°F). Avoid heat over 30°C (86°F).
    • do not use if suppository wrapper is missing or damaged (each suppository is individually wrapped)

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  • INACTIVE INGREDIENT SECTION

    hydrogenated vegetable oil base

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  • OTC - QUESTIONS SECTION

    QUESTION?
    call 1-800-922-1038

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  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

    Miconazole Nitrate Vaginal Suppositories USP, 100 mg

    NDC 42254-295-07

    7 Day Treatment
    Miconazole Nitrate Vaginal Suppositories USP, 100 mg
    Cures Most Vaginal Yeast Infections
    Contains 7 Vaginal Suppositories

    Drug Facts
    Active ingredient (in each vaginal suppository)                                                                         Purpose
    Miconazole nitrate 100 mg.........................................................................................Vaginal antifungal

    Use
    • treats vaginal yeast infections
    Warnings
    For vaginal use only
    Do not use
    if you have never had a vaginal yeast infection diagnosed by a doctor

    Ask a doctor before use if you have
    • vaginal itching and discomfort for the first time
    • lower abdominal, back or shoulder pain, fever, chills, nausea, vomiting, or foul-smelling vaginal discharge
    • vaginal yeast infections often (such as once a month or 3 in 6 months). You could be pregnant or have a serious underlying medical cause for your symptoms, including diabetes or a weakened immune system.
    • been exposed to the human immunodeficiency virus (HIV) that causes AIDS

    Ask a doctor or pharmacist before use if you are taking the prescription blood thinning medicine warfarin, because bleeding or bruising may occur.

    When using this product
    • do not use tampons, douches, spermicides, or other vaginal products. Condoms and diaphragms may be damaged by this product and fail to prevent pregnancy or sexually transmitted diseases (STDs).
    • do not have vaginal intercourse

    Stop use and ask a doctor if
    • symptoms do not get better in 3 days
    • symptoms last more than 7 days
    • you get a rash, abdominal pain, fever, chills, nausea, vomiting, or foul-smelling vaginal discharge

    If pregnant or breast-feeding, ask a health professional before use
    Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

    Directions
    • before using this product, read the enclosed brochure for complete instructions
    • adults and children 12 years of age and over:
           • insert 1 suppository into the vagina at bedtime for 7 nights in a row     • wash applicator after each use
    • children under 12 years of age: ask a doctor

    Drug Facts
    (continued)
    Other information
    • store at 15°-30°C (59°-86°F). Avoid heat over 30°C (86°F).
    • do not use if suppository wrapper is missing or damaged (each suppository is individually wrapped)

    Inactive ingredient
    hydrogenated vegetable oil base

    Drug Facts
    (continued)
    Questions? call 1-800-922-1038

    Manufactured by: G&W Laboratories, Inc.
    111 Coolidge Street
    South Plainfield, NJ 07080
    Visit our website @ www.gwlabs.com

    Repackaged by: Rebel Distributors Corp.
    3607 Old Conejo Rd.
    Thousand Oaks, CA 91320

     


    TAMPER-EVIDENT: For your safety each suppository is individually wrapped. If a suppository is unwrapped or there are signs of tampering, DO NOT USE.
     

    Miconazole Nitrate 100mg
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  • INGREDIENTS AND APPEARANCE
    MICONAZOLE NITRATE 
    miconazole nitrate suppository
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:42254-295(NDC:0713-0197)
    Route of Administration VAGINAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    Miconazole Nitrate (UNII: VW4H1CYW1K) (Miconazole - UNII:7NNO0D7S5M) Miconazole Nitrate 100 ug
    Inactive Ingredients
    Ingredient Name Strength
    Hydrogenated Coconut Oil (UNII: JY81OXM1OM)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:42254-295-07 7 in 1 BOX
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    ANDA ANDA074414 04/30/1997
    Labeler - Rebel Distributors Corp (118802834)
    Registrant - PSS World Medical, Inc. (101822862)
    Establishment
    Name Address ID/FEI Business Operations
    PSS World Medical, Inc. 791528623 REPACK(42254-295)
    Establishment
    Name Address ID/FEI Business Operations
    STAT RX USA LLC 786036330 REPACK(42254-295)
    Establishment
    Name Address ID/FEI Business Operations
    Dispensing Solutions, Inc. 066070785 RELABEL(42254-295) , REPACK(42254-295)
    Establishment
    Name Address ID/FEI Business Operations
    SCRIPT PAK 964420108 RELABEL(42254-295) , REPACK(42254-295)
    Establishment
    Name Address ID/FEI Business Operations
    Keltman Pharmaceuticals, Inc. 362861077 REPACK(42254-295)
    Establishment
    Name Address ID/FEI Business Operations
    Rebel Distirbutors Corp. 118802834 RELABEL(42254-295) , REPACK(42254-295)
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