MICONAZOLE 7 (MICONAZOLE NITRATE) SUPPOSITORY [ACTAVIS PHARMA, INC.]

MICONAZOLE 7 (MICONAZOLE NITRATE) SUPPOSITORY [ACTAVIS PHARMA, INC.]
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NDC 0472-1736-07
Set ID 3d3968de-f298-4b59-acfa-1caf1e4631c1
Category HUMAN OTC DRUG LABEL
Packager Actavis Pharma, Inc.
Generic Name
Product Class Azole Antifungal
Product Number
Application Number ANDA073507
  • Drug Facts
  • Active ingredient (in each vaginal suppository)

    Miconazole nitrate, USP 100 mg

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  • Purpose

    Vaginal antifungal

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  • Use

    • treats vaginal yeast infections
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  • 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
    • vaginal yeast infections often (such as once a month or 3 in 6 months). You may have a more serious condition. You could be pregnant or have a medical condition, such as diabetes or a weakened immune system.
    • lower abdominal, back, or shoulder pain, fever, chills, nausea, vomiting, or foul-smelling vaginal discharge
    • been exposed to the human immunodeficiency virus (HIV) that causes AIDS

    Ask a doctor or pharmacist before use if you are

    taking a prescription blood thinning medicine, such as warfarin, because bleeding or bruising may occur

    When using this product

    • do not use tampons, douches, spermicides or other vaginal products
    • do not use condoms or diaphragms. They may be damaged by this product and not prevent pregnancy or sexually transmitted diseases (STDs).
    • do not have vaginal intercourse (sex)
    • mild increase in vaginal burning, itching or irritation may occur

    Stop use and ask a doctor if

    • side effects occur.
    • symptoms do not get better after 3 days
    • symptoms last more than 7 days
    • you get a rash or hives, 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.

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  • Directions

    • before using this product read the enclosed consumer information leaflet for complete instructions and information
    • 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 use.
    • children under 12 years: ask a doctor
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  • Other information

    • do not purchase if carton is open
    • each suppository is individually wrapped. Do not use if wrapper is missing or damaged.
    • Store at 20°-25°C (68°-77°F) [see USP Controlled Room Temperature] excursions permitted to 15°-30°C (59°-86°F).
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  • Inactive ingredient

    hydrogenated vegetable oil

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  • Questions?

    1-888-838-2872 between 9 am and 5 pm ET, Monday–Friday.

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  • Principal Display Panel

    Actavis

    NDC 0472-1736-07

    Compare to the active ingredient
    in Monistat® 7 Vaginal Suppositories*

    Miconazole 7

    Miconazole Nitrate Vaginal Suppositories, USP 100 mg

    Vaginal Antifungal

    Cures Most Vaginal Yeast Infections

    7 Vaginal Suppositories
    with 1 Reusable Plastic Applicator

    image
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  • INGREDIENTS AND APPEARANCE
    MICONAZOLE 7 
    miconazole nitrate suppository
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:0472-1736
    Route of Administration VAGINAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    MICONAZOLE NITRATE (UNII: VW4H1CYW1K) (MICONAZOLE - UNII:7NNO0D7S5M) MICONAZOLE NITRATE 100 mg
    Inactive Ingredients
    Ingredient Name Strength
    HYDROGENATED PALM KERNEL OIL (UNII: FM8D1RE2VP)  
    PALM KERNEL OIL (UNII: B0S90M0233)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:0472-1736-07 7 in 1 BOX; Type 1: Convenience Kit of Co-Package 03/01/1997
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    ANDA ANDA073507 03/01/1997
    Labeler - Actavis Pharma, Inc. (119723554)
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