MICONAZOLE NITRATE- miconazole nitrate suppository 
Rebel Distributors Corp

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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

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 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

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
MICONAZOLE NITRATE 
miconazole nitrate suppository
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:42254-295(NDC:0713-0197)
Route of Administration VAGINAL DEA Schedule     
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:42254-295-07 7 in 1 BOX
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA074414 04/30/1997
Labeler - Rebel Distributors Corp (118802834)
Registrant - PSS World Medical, Inc. (101822862)
Establishment
Name Address ID/FEI Business Operations
PSS World Medical, Inc. 791528623 REPACK(42254-295)
Establishment
Name Address ID/FEI Business Operations
STAT RX USA LLC 786036330 REPACK(42254-295)
Establishment
Name Address ID/FEI Business Operations
Dispensing Solutions, Inc. 066070785 RELABEL(42254-295) , REPACK(42254-295)
Establishment
Name Address ID/FEI Business Operations
SCRIPT PAK 964420108 RELABEL(42254-295) , REPACK(42254-295)
Establishment
Name Address ID/FEI Business Operations
Keltman Pharmaceuticals, Inc. 362861077 REPACK(42254-295)
Establishment
Name Address ID/FEI Business Operations
Rebel Distirbutors Corp. 118802834 RELABEL(42254-295) , REPACK(42254-295)

Revised: 9/2012
Document Id: 0e4c7ff6-7bea-4257-bd95-d4d5298ae426
Set id: 0e4c7ff6-7bea-4257-bd95-d4d5298ae426
Version: 1
Effective Time: 20120926
 
Rebel Distributors Corp