FDA Label for Miconazole 7
View Indications, Usage & Precautions
- 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
- STOP USE AND ASK A DOCTOR IF
- IF PREGNANT OR BREAST-FEEDING,
- KEEP OUT OF REACH OF CHILDREN.
- DIRECTIONS
- OTHER INFORMATION
- INACTIVE INGREDIENT
- QUESTIONS?
- PRINCIPAL DISPLAY PANEL
Miconazole 7 Product Label
The following document was submitted to the FDA by the labeler of this product Strategic Sourcing Services Llc. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
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 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 room temperature 15°-30°C (59°-86°F), avoid heat over 30°C or 86°F.
Inactive Ingredient
hydrogenated vegetable oil
Questions?
1-800-432-8534 between 9 am and 4 pm EST, Monday - Friday.
Principal Display Panel
sunmark®
COMPARE TO THE ACTIVE INGREDIENT IN
MONISTAT® 7 VAGINAL SUPPOSITORIES*
NDC 49348-833-61
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
* Please review the disclaimer below.