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Miconazole 7 by McKesson

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

Miconazole 7 Vaginal Suppositories

Drug Facts

Active ingredient (in each vaginal suppository)

Miconazole nitrate 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
  • ech 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 (select option #2)

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 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 
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)

Revised: 06/2014
 
McKesson

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Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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