MICONAZOLE NITRATE- miconazole nitrate suppository

Country: Ամերիկայի Միացյալ Նահանգներ

language: անգլերեն

source: NLM (National Library of Medicine)

active_ingredient:

MICONAZOLE NITRATE (UNII: VW4H1CYW1K) (MICONAZOLE - UNII:7NNO0D7S5M)

MAH:

Cosette Pharmaceuticals, Inc.

INN:

Miconazole Nitrate

composition:

Miconazole Nitrate 100 ug

administration_route:

VAGINAL

prescription_type:

OTC DRUG

therapeutic_indication:

Vaginal Antifungal Use • treats vaginal yeast infections

authorization_status:

Abbreviated New Drug Application

SPC

MICONAZOLE NITRATE - MICONAZOLE NITRATE SUPPOSITORY
COSETTE PHARMACEUTICALS, INC.
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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 instr