MICONAZOLE 3 COMBINATION PACK- miconazole nitrate kit

Country: United States

Language: English

Source: NLM (National Library of Medicine)

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Active ingredient:

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

Available from:

Major Pharmaceuticals

Administration route:

VAGINAL

Prescription type:

OTC DRUG

Therapeutic indications:

Vaginal antifungal - treats vaginal yeast infections - relieves external itching and irritation due to a vaginal yeast infection

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

                                MICONAZOLE 3 COMBINATION PACK- MICONAZOLE NITRATE
MAJOR PHARMACEUTICALS
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MICONAZOLE 3 COMBINATION PACK
_DRUG FACTS_
_ACTIVE INGREDIENTS_
Miconazole nitrate, USP 200 mg (in each suppository)
Miconazole nitrate, USP 2% (external cream)
_PURPOSE_
Vaginal antifungal
_USES_
treats vaginal yeast infections
relieves external itching and irritation due to a vaginal yeast
infection
_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. YOU MAY HAVE A MORE SERIOUS
CONDITION.
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 and bruising
may occur.
WHEN USING THIS PRODUCT
do not use tampons, douches, spermicides or other vaginal products.
Condoms and
diaphragms may be damaged and fail to prevent pregnancy or sexually
transmitted
diseases (STDs).
do not have vaginal intercourse
mild increase in vaginal burning, itching or irritation may occur.
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 or hives, abdominal pain, fever, chills, nausea,
vomiting, or foul-
smelling 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 consumer information
leaflet for
complete directions and information
ADULTS AND CHILDREN 12 YEARS OF AGE AND OVER:
SUPPOSITORIES: insert 1 suppository into 
                                
                                Read the complete document
                                
                            

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