MICONAZOLE NITRATE- miconazole nitrate suppository
Miconazole Nitrate by
Drug Labeling and Warnings
Miconazole Nitrate by is a Otc medication manufactured, distributed, or labeled by Cosette Pharmaceuticals, Inc.. Drug facts, warnings, and ingredients follow.
Drug Details [pdf]
- OTC - ACTIVE INGREDIENT SECTION
- OTC - PURPOSE SECTION
- INDICATIONS & USAGE SECTION
-
WARNINGS SECTION
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
lower abdominal, back or shoulder pain, fever, chills, nausea, vomiting, or foul-smelling vaginal discharge
vaginal yeast infections often (such as once a month or 3 in 6 months). You could be pregnant or have a serious underlying medical cause for your symptoms, including diabetes or a weakened immune system.
been exposed to the human immunodeficiency virus (HIV) that causes AIDS
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. Condoms and diaphragms may be damaged by this product and fail to prevent pregnancy or sexually transmitted diseases (STDs).
do not have vaginal intercourse
Stop use and ask a doctor if
symptoms do not get better in 3 days
symptoms last more than 7 days
you get a rash, abdominal pain, fever, chills, nausea, vomiting, or foul-smelling vaginal discharge
In case of accidental ingestion, seek professional assistance or contact a poison control center immediately. - OTC - PREGNANCY OR BREAST FEEDING SECTION
- OTC - KEEP OUT OF REACH OF CHILDREN SECTION
- DOSAGE & ADMINISTRATION SECTION
- STORAGE AND HANDLING SECTION
- INACTIVE INGREDIENT SECTION
- OTC - QUESTIONS SECTION
-
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
Miconazole Nitrate Vaginal Suppositories USP, 100 mg
G&W NDC: 0713-0197-57
7 Day Treatment
Miconazole Nitrate Vaginal Suppositories USP, 100 mg
Cures Most Vaginal Yeast Infections
Contains 7 Vaginal Suppositories
Drug Facts
Active ingredient (in each vaginal suppository) Purpose
Miconazole nitrate 100 mg.........................................................................................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
lower abdominal, back or shoulder pain, fever, chills, nausea, vomiting, or foul-smelling vaginal discharge
vaginal yeast infections often (such as once a month or 3 in 6 months). You could be pregnant or have a serious underlying medical cause for your symptoms, including diabetes or a weakened immune system.
been exposed to the human immunodeficiency virus (HIV) that causes AIDS
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. Condoms and diaphragms may be damaged by this product and fail to prevent pregnancy or sexually transmitted diseases (STDs).
do not have vaginal intercourse
Stop use and ask a doctor if
symptoms do not get better in 3 days
symptoms last more than 7 days
you get a rash, 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 brochure for complete instructions
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 each use
children under 12 years of age: ask a doctor
Drug Facts (continued)
Other information
store at 15°-30°C (59°-86°F). Avoid heat over 30°C (86°F).
do not use if suppository wrapper is missing or damaged (each suppository is individually wrapped)
Inactive ingredienthydrogenated vegetable oil base
Drug Facts (continued)
Questions? call 1-800-922-1038
Manufactured by: G&W Laboratories, Inc.
111 Coolidge Street
South Plainfield, NJ 07080
Visit our website @ www.gwlabs.com
80% UPC N3-0713-0197-57 keyline does not print
TAMPER-EVIDENT: For your safety each suppository is individually wrapped. If a suppository is unwrapped or there are signs of tampering, DO NOT USE.
-
INGREDIENTS AND APPEARANCE
MICONAZOLE NITRATE
miconazole nitrate suppositoryProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC: 0713-0197 Route of Administration VAGINAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength MICONAZOLE NITRATE (UNII: VW4H1CYW1K) (MICONAZOLE - UNII:7NNO0D7S5M) MICONAZOLE NITRATE 100 ug Inactive Ingredients Ingredient Name Strength HYDROGENATED COCONUT OIL (UNII: JY81OXM1OM) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC: 0713-0197-57 7 in 1 BOX; Type 0: Not a Combination Product 04/30/1997 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA074414 04/30/1997 Labeler - Cosette Pharmaceuticals, Inc. (116918230) Registrant - Cosette Pharmaceuticals, Inc. (116918230) Establishment Name Address ID/FEI Business Operations Cosette Pharmaceuticals, Inc. 116918230 analysis(0713-0197) , manufacture(0713-0197) , label(0713-0197) , pack(0713-0197)
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.