MICONAZOLE 7 (MICONAZOLE NITRATE) SUPPOSITORY [MCKESSON]

MICONAZOLE 7 (MICONAZOLE NITRATE) SUPPOSITORY [MCKESSON]
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NDC 49348-833-61
Set ID 89132802-beb1-42f4-8da4-39918fc5c4dd
Category HUMAN OTC DRUG LABEL
Packager Strategic Sourcing Services LLC
Generic Name
Product Class Azole Antifungal
Product Number
Application Number ANDA073507
  • Drug Facts

  • Active ingredient (in each vaginal suppository)

    Miconazole nitrate, USP 100 mg

  • Purpose

    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
    • 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 (1-800-222-1222) right away.

  • 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
  • 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 20º-25ºC (68º-77ºF) [see USP Controlled Room Temperature] excursions permitted to 15º-30ºC (59º-86ºF).
  • Inactive ingredient

    hydrogenated vegetable oil

  • Questions?

    Call 1-877-753-3935 Monday-Friday 9AM-5PM EST

  • Principal display panel

    COMPARETO MONISTAT® 7 ACTIVE INGREDIENT*

    miconazole 7

    Vaginal Suppositories

    Miconazole Nitrate Vaginal

    Suppositories, USP 100 mg

    Vaginal antifungal

    Cures most vaginal yeast infections

    7 VAGINAL SUPPOSITORIES WITH 1 REUSABLE PLASTIC APPLICATOR

    *This product is not affiliated with, manufactured by, or produced by the makers or owners of Monistat®

    Another Quality Product

    Distributed by McKesson

    6555 State Highway 161 Irving, TX 75039

    www.sunmarkbrand.com

  • Package label

    Miconazole Nitrate, USP 100 mg

    SUNMARK Vaginal Suppositories

  • INGREDIENTS AND APPEARANCE
    MICONAZOLE 7 
    miconazole nitrate suppository
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49348-833
    Route of AdministrationVAGINAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MICONAZOLE NITRATE (UNII: VW4H1CYW1K) (MICONAZOLE - UNII:7NNO0D7S5M) MICONAZOLE NITRATE100 mg
    Inactive Ingredients
    Ingredient NameStrength
    HYDROGENATED PALM KERNEL OIL (UNII: FM8D1RE2VP)  
    PALM KERNEL OIL (UNII: B0S90M0233)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:49348-833-617 in 1 APPLICATOR; Type 0: Not a Combination Product12/09/2011
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA07350712/09/2011
    Labeler - Strategic Sourcing Services LLC (116956644)