MICONAZOLE 7- miconazole nitrate suppository 
Actavis Pharma, Inc.

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Miconazole Nitrate Vaginal Suppositories, USP

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 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?

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

Principal Display Panel

Actavis

NDC 0472-1736-07

Compare to the active ingredient
in Monistat® 7 Vaginal Suppositories*

Miconazole 7

Miconazole Nitrate Vaginal Suppositories, USP 100 mg

Vaginal Antifungal

Cures Most Vaginal Yeast Infections

7 Vaginal Suppositories
with 1 Reusable Plastic Applicator

image
MICONAZOLE 7 
miconazole nitrate suppository
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0472-1736
Route of AdministrationVAGINAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MICONAZOLE NITRATE (UNII: VW4H1CYW1K) (MICONAZOLE - UNII:7NNO0D7S5M) MICONAZOLE NITRATE100 mg
Inactive Ingredients
Ingredient NameStrength
HYDROGENATED PALM KERNEL OIL (UNII: FM8D1RE2VP)  
PALM KERNEL OIL (UNII: B0S90M0233)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0472-1736-077 in 1 BOX; Type 0: Not a Combination Product03/01/1997
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07350703/01/199702/28/2022
Labeler - Actavis Pharma, Inc. (119723554)

Revised: 10/2021
 
Actavis Pharma, Inc.