MICONAZOLE 7- miconazole nitrate suppository

Miconazole 7 by

Drug Labeling and Warnings

Miconazole 7 by is a Otc medication manufactured, distributed, or labeled by H2-Pharma, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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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 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
• 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

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Distributed by: H2-Pharma, LLC
Montgomery, AL 36117

PRINCIPAL DISPLAY PANEL - 100 mg Suppository Box

NDC: 61269-736-07
*Compare to the active ingredient in
Monistat® 7

Miconazole 7

Miconazole nitrate
Vaginal suppositories, USP 100 mg
Vaginal antifungal

Cures most vaginal yeast infections

7 vaginal suppositories with 1 reusable plastic applicator

H2 pharma

INGREDIENTS AND APPEARANCE

MICONAZOLE 7 
miconazole nitrate suppository

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 61269-736
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)

Product Characteristics
Color	WHITE	Score
Shape	OVAL	Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 61269-736-07	7 in 1 BOX; Type 0: Not a Combination Product	05/24/2021

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA073507	05/24/2021

Labeler - H2-Pharma, LLC (028473634)