Active Ingredient (In Each Vaginal Suppository)
Miconazole nitrate, USP 100 mg
Miconazole 7 Suppository
FDA Label NDC 49348-833
17 label sections · Submitted to the FDA by Strategic Sourcing Services Llc · Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Strategic Sourcing Services Llc for the product Miconazole 7 (NDC 49348-833). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding active ingredient (in each vaginal suppository), purpose, use, warnings, do not use, ask a doctor before use if you have, ask a doctor or pharmacist before use if you are, when using this product, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
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 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
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
Package Label
SUNMARK Vaginal Suppositories
* Please review the disclaimer below.
