NDC | 0472-1736-07 |
Set ID | 3d3968de-f298-4b59-acfa-1caf1e4631c1 |
Category | HUMAN OTC DRUG LABEL |
Packager | Actavis Pharma, Inc. |
Generic Name | |
Product Class | Azole Antifungal |
Product Number | |
Application Number | ANDA073507 |
- Drug Facts
- Active ingredient (in each vaginal suppository)
- Purpose
- Use
- Warnings
For vaginal use only
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
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
- Questions?
- 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 - INGREDIENTS AND APPEARANCE
MICONAZOLE 7
miconazole nitrate suppositoryProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0472-1736 Route of Administration VAGINAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength MICONAZOLE NITRATE (UNII: VW4H1CYW1K) (MICONAZOLE - UNII:7NNO0D7S5M) MICONAZOLE NITRATE 100 mg Inactive Ingredients Ingredient Name Strength HYDROGENATED PALM KERNEL OIL (UNII: FM8D1RE2VP) PALM KERNEL OIL (UNII: B0S90M0233) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0472-1736-07 7 in 1 BOX; Type 1: Convenience Kit of Co-Package 03/01/1997 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA073507 03/01/1997 Labeler - Actavis Pharma, Inc. (119723554)