Miconazole Nitrate Vaginal Suppositories, Usp

Miconazole Nitrate Vaginal Suppositories, Usp
SPL v14
SPL
SPL Set ID 89132802-beb1-42f4-8da4-39918fc5c4dd
Route
VAGINAL
Published
Effective Date 2025-09-09
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Miconazole (100 mg)
Inactive Ingredients
Hydrogenated Palm Kernel Oil Palm Kernel Oil

Identifiers & Packaging

Marketing Status
ANDA Completed Since 2011-12-09 Until 2026-12-09

Description

Miconazole nitrate, USP 100 mg

Purpose

Vaginal antifungal


Medication Information

Purpose

Vaginal antifungal

Description

Miconazole nitrate, USP 100 mg

Use
  • treats vaginal yeast infections
Warnings

For vaginal use only

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
Do Not Use

if you have never had a vaginal yeast infection diagnosed by a doctor

Questions?

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

Package Label
SUNMARK Vaginal Suppositories
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

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®

Distributed by McKesson Corp.,

via Strategic Sourcing Services LLC,

Memphis, TN 38141

www.sunmarkbrand.com

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.

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
Active Ingredient (in Each Vaginal Suppository)

Miconazole nitrate, USP 100 mg

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


Structured Label Content

Use
  • treats vaginal yeast infections
Purpose

Vaginal antifungal

Warnings

For vaginal use only

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
Do Not Use (Do not use)

if you have never had a vaginal yeast infection diagnosed by a doctor

Questions?

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

Package Label (Package label)
SUNMARK Vaginal Suppositories
Other Information (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 (Inactive ingredient)

hydrogenated vegetable oil

Principal Display Panel (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®

Distributed by McKesson Corp.,

via Strategic Sourcing Services LLC,

Memphis, TN 38141

www.sunmarkbrand.com

When Using This Product (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 (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, (If pregnant or breast-feeding,)

ask a health professional before use.

Keep Out of Reach of Children. (Keep out of reach of children.)

If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Ask A Doctor Before Use If You Have (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
Active Ingredient (in Each Vaginal Suppository) (Active ingredient (in each vaginal suppository))

Miconazole nitrate, USP 100 mg

Ask A Doctor Or Pharmacist Before Use If You Are (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


Advanced Ingredient Data


Raw Label Data

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