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Miconazole 7 by McKesson

Medically reviewed on Dec 6, 2017

Dosage form: suppository
Ingredients: MICONAZOLE NITRATE 100mg
Labeler: McKesson
NDC Code: 49348-833

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 room temperature 15º-30ºC (59º-86ºF), avoid heat over 30ºC or 86ºF.

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

MICONAZOLE 7 
miconazole nitrate suppository
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49348-833
Route of AdministrationVAGINALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MICONAZOLE NITRATE (MICONAZOLE) MICONAZOLE NITRATE100 mg
Inactive Ingredients
Ingredient NameStrength
HYDROGENATED PALM KERNEL OIL 
PALM KERNEL OIL 
Packaging
#Item CodePackage Description
1NDC:49348-833-617 SUPPOSITORY in 1 APPLICATOR
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07350712/09/2011
Labeler - McKesson (177667227)
Registrant - Teva Pharmaceuticals USA, Inc. (001627975)

 
McKesson

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Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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