Miconazole 7

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Contacts and useful links#

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient (in each vaginal suppository)

OTC - ACTIVE INGREDIENT SECTION

Miconazole nitrate, USP 100 mg

Purpose

OTC - PURPOSE SECTION

Vaginal antifungal

Use

INDICATIONS & USAGE SECTION

• treats vaginal yeast infections

Warnings

WARNINGS SECTION

For vaginal use only

OTC - DO NOT USE SECTION

Do not use if you have never had a vaginal yeast infection diagnosed by a doctor.

Ask a doctor before use if you have

OTC - ASK DOCTOR SECTION

• 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

OTC - ASK DOCTOR/PHARMACIST SECTION

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

OTC - WHEN USING SECTION

• 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

OTC - STOP USE SECTION

• 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

OTC - PREGNANCY OR BREAST FEEDING SECTION

If pregnant or breast-feeding, ask a health professional before use.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Directions

DOSAGE & ADMINISTRATION SECTION

• 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

STORAGE AND HANDLING SECTION

• 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

INACTIVE INGREDIENT SECTION

hydrogenated vegetable oil

Questions?

OTC - QUESTIONS SECTION

Call 1-877-753-3935 Monday-Friday 9AM-5PM EST

SPL UNCLASSIFIED SECTION

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

PRINCIPAL DISPLAY PANEL - 100 mg Suppository Box

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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

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Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 5 matching rows.

• Miconazole 7
• Miconazole Nitrate
• MICONAZOLE
• HYDROGENATED PALM KERNEL OIL
• PALM KERNEL OIL

NDC Codes#

Ingredients#

Every source-derived ingredient row is available through these pages.

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Source Document#

Source XML

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Orange Book products#

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Observed Orange Book product history#

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Product history page 1 of 2 · 44 observed states.

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Reported adverse events (FAERS/openFDA)#

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