Miconazole 7

SPL UNCLASSIFIED SECTION

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

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

• 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

• 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

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

• 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

SPL UNCLASSIFIED SECTION

Distributed by: H2-Pharma, LLCMontgomery, AL 36117