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Miconazole Nitrate by G&W Laboratories, Inc.

Dosage form: suppository
Ingredients: Miconazole Nitrate 100ug
Labeler: G&W Laboratories, Inc.
NDC Code: 0713-0197

Miconazole Nitrate, Vaginal Suppositories USP, 100 mg

OTC - ACTIVE INGREDIENT SECTION

Miconazole nitrate 100 mg

OTC - PURPOSE SECTION

Vaginal Antifungal

INDICATIONS & USAGE SECTION

Use
• treats vaginal yeast infections

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

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 right away.

DOSAGE & ADMINISTRATION SECTION

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

STORAGE AND HANDLING SECTION

• 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 INGREDIENT SECTION

hydrogenated vegetable oil base

OTC - QUESTIONS SECTION

QUESTION?
call 1-800-922-1038

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 ingredient
hydrogenated 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.
 

MICONAZOLE NITRATE  
miconazole nitrate suppository
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0713-0197
Route of AdministrationVAGINALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Miconazole Nitrate (Miconazole) Miconazole Nitrate100 ug
Inactive Ingredients
Ingredient NameStrength
Hydrogenated Coconut Oil 
Packaging
#Item CodePackage Description
1NDC:0713-0197-577 SUPPOSITORY (SUPPOSITORY) in 1 BOX
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07441404/30/1997
Labeler - G&W Laboratories, Inc. (001271188)
Registrant - G&W Laboratories, Inc. (001271188)
Establishment
NameAddressID/FEIOperations
G&W Laboratories, Inc.001271188MANUFACTURE

Revised: 01/2012
 
G&W Laboratories, Inc.

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Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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