Label: MICONAZOLE 7- miconazole nitrate suppository

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

Drug Label Information

Updated May 24, 2021

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

  • SPL UNCLASSIFIED SECTION

    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 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
    • 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 20°-25°C (68°-77°F) [see USP Controlled Room Temperature] excursions permitted to 15°-30°C (59°-86°F)
  • Inactive ingredient

    hydrogenated vegetable oil

  • Questions?

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

  • SPL UNCLASSIFIED SECTION

    Distributed by: H2-Pharma, LLC
    Montgomery, AL 36117

  • PRINCIPAL DISPLAY PANEL - 100 mg Suppository Box

    NDC 61269-736-07
    *Compare to the active ingredient in
    Monistat® 7

    Miconazole 7

    Miconazole nitrate
    Vaginal suppositories, USP 100 mg
    Vaginal antifungal

    Cures most vaginal yeast infections

    7 vaginal suppositories with 1 reusable plastic applicator

    H2 pharma

    PRINCIPAL DISPLAY PANEL - 100 mg Suppository Box
  • INGREDIENTS AND APPEARANCE
    MICONAZOLE 7 
    miconazole nitrate suppository
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61269-736
    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)  
    Product Characteristics
    ColorWHITEScore    
    ShapeOVALSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:61269-736-077 in 1 BOX; Type 0: Not a Combination Product05/24/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA07350705/24/2021
    Labeler - H2-Pharma, LLC (028473634)