FDA Label for Miconazole Nitrate

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

NDC 42254-295-07

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

Repackaged by: Rebel Distributors Corp.
3607 Old Conejo Rd.
Thousand Oaks, CA 91320

 


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 100mg - 0e4c7ff6 7bea 4257 bd95 d4d5298ae426 01