MICONAZOLE NITRATE- miconazole nitrate suppository 
Rebel Distributors Corp

----------

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 TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:42254-295(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 DescriptionMarketing Start DateMarketing End Date
1NDC:42254-295-077 in 1 BOX
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07441404/30/1997
Labeler - Rebel Distributors Corp (118802834)
Registrant - PSS World Medical, Inc. (101822862)
Establishment
NameAddressID/FEIBusiness Operations
PSS World Medical, Inc.791528623REPACK(42254-295)
Establishment
NameAddressID/FEIBusiness Operations
STAT RX USA LLC786036330REPACK(42254-295)
Establishment
NameAddressID/FEIBusiness Operations
Dispensing Solutions, Inc.066070785RELABEL(42254-295), REPACK(42254-295)
Establishment
NameAddressID/FEIBusiness Operations
SCRIPT PAK964420108RELABEL(42254-295), REPACK(42254-295)
Establishment
NameAddressID/FEIBusiness Operations
Keltman Pharmaceuticals, Inc.362861077REPACK(42254-295)
Establishment
NameAddressID/FEIBusiness Operations
Rebel Distirbutors Corp.118802834RELABEL(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