MICONAZOLE 7- miconazole nitrate suppository

Miconazole 7 by

Drug Labeling and Warnings

Miconazole 7 by is a Otc medication manufactured, distributed, or labeled by Strategic Sourcing Services LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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 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 20º-25ºC (68º-77ºF) [see USP Controlled Room Temperature] excursions permitted to 15º-30ºC (59º-86ºF).

Inactive ingredient

hydrogenated vegetable oil

Questions?

1-888-838-2872 between 9 am and 5 pm ET, Monday-Friday.

Principal Display Panel

sunmark®

COMPARE TO MONISTAT® 7 ACTIVE INGREDIENT*

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

INGREDIENTS AND APPEARANCE

MICONAZOLE 7 
miconazole nitrate suppository

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 49348-833
Route of Administration	VAGINAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MICONAZOLE NITRATE (UNII: VW4H1CYW1K) (MICONAZOLE - UNII:7NNO0D7S5M)	MICONAZOLE NITRATE	100 mg

Inactive Ingredients
Ingredient Name	Strength
HYDROGENATED PALM KERNEL OIL (UNII: FM8D1RE2VP)
PALM KERNEL OIL (UNII: B0S90M0233)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 49348-833-61	7 in 1 APPLICATOR; Type 0: Not a Combination Product	12/09/2011

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA073507	12/09/2011

Labeler - Strategic Sourcing Services LLC (116956644)