MICONAZOLE NITRATE suppository

Miconazole Nitrate by

Drug Labeling and Warnings

Miconazole Nitrate by is a Otc medication manufactured, distributed, or labeled by Rebel Distributors Corp, PSS World Medical, Inc., STAT RX USA LLC, Dispensing Solutions, Inc., SCRIPT PAK, Keltman Pharmaceuticals, Inc., Rebel Distirbutors Corp.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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.
 

INGREDIENTS AND APPEARANCE

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

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)