NDC | 0713-0197-57 |
Set ID | 915b373a-cfe6-f22f-602a-bb05cd3b4109 |
Category | HUMAN OTC DRUG LABEL |
Packager | Cosette Pharmaceuticals, Inc. |
Generic Name | |
Product Class | Azole Antifungal |
Product Number | |
Application Number | ANDA074414 |
- OTC - ACTIVE INGREDIENT SECTION
- OTC - PURPOSE SECTION
- INDICATIONS & USAGE SECTION
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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
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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.
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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)