MICONAZOLE NITRATE (MICONAZOLE NITRATE) SUPPOSITORY [G&W LABORATORIES, INC.]

MICONAZOLE NITRATE (MICONAZOLE NITRATE) SUPPOSITORY [G&W LABORATORIES, INC.]
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NDC 0713-0197-57
Set ID 915b373a-cfe6-f22f-602a-bb05cd3b4109
Category HUMAN OTC DRUG LABEL
Packager Cosette Pharmaceuticals, Inc.
Generic Name
Product Class Azole Antifungal
Product Number
Application Number ANDA074414
  • OTC - ACTIVE INGREDIENT SECTION

    Miconazole nitrate 100 mg

  • OTC - PURPOSE SECTION

    Vaginal Antifungal

  • INDICATIONS & USAGE SECTION

    Use
    • treats vaginal yeast infections

  • 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.

  • OTC - PREGNANCY OR BREAST FEEDING SECTION

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

  • 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.

  • 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

  • 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)

  • INACTIVE INGREDIENT SECTION

    hydrogenated vegetable oil base

  • OTC - QUESTIONS SECTION

    QUESTION?
    call 1-800-922-1038

  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

    Miconazole Nitrate Vaginal Suppositories USP, 100 mg

    G&W NDC 0713-0197-57

    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

    80% UPC N3-0713-0197-57 keyline does not print

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

    Packaging Carton
  • INGREDIENTS AND APPEARANCE
    MICONAZOLE NITRATE  
    miconazole nitrate suppository
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0713-0197
    Route of AdministrationVAGINAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MICONAZOLE NITRATE (UNII: VW4H1CYW1K) (MICONAZOLE - UNII:7NNO0D7S5M) MICONAZOLE NITRATE100 ug
    Inactive Ingredients
    Ingredient NameStrength
    HYDROGENATED COCONUT OIL (UNII: JY81OXM1OM)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0713-0197-577 in 1 BOX; Type 0: Not a Combination Product04/30/1997
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA07441404/30/1997
    Labeler - Cosette Pharmaceuticals, Inc. (116918230)
    Registrant - Cosette Pharmaceuticals, Inc. (116918230)
    Establishment
    NameAddressID/FEIBusiness Operations
    Cosette Pharmaceuticals, Inc.116918230analysis(0713-0197) , manufacture(0713-0197) , label(0713-0197) , pack(0713-0197)