Oravig Buccal Tablet 50Mg Drug Medication Dosage Information
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Oravig: Buccal tablet (50mg)

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Drug Image file DrugItem_14231.JPG
Oravig Buccal Tab
Par Pharmaceuticals
Pill Identification:
Drug Image file DrugItem_15867.JPG
ORAVIG 50mg Buccal Tablet
Praelia Pharmaceuticals
Pill Identification:

What is this Medicine?

MICONAZOLE (mi KON a zole) is an antifungal medicine. It is used to treat certain kinds of fungal or yeast infections of the mouth.

In-Depth Information
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ORAVIG 50mg Buccal Tablet

NDC: 432880250
  • Prescription Required
  • Not a Controlled Drug
    (CSA Schedule)
  • FDA Approved




FDA approved for the following conditions:
Mucocutaneous Candidiasis, Oropharyngeal Candidiasis (thrush), Vulvovaginal Candidiasis

Sometimes used for but not FDA approved for the following conditions:
Diaper Dermatitis

Storage Information
Store at room temperature (68 to 77 degrees F); brief excursions permitted to 59 to 104 degrees F
Protect from moisture
ORAVIG 50mg Buccal Tablet
Drug Image file DrugItem_15867.JPG
Praelia Pharmaceuticals
Pill Identification:
Shape: round
Color: white

Reported Side Effects for ORAVIG 50mg Buccal Tablet

Upset Stomach Incidence:
0.7-6.6%*
Severity: MILD
Onset: EARLY
Vomiting Incidence:
0.7-3.8%*
Severity: MILD
Onset: EARLY
Elevated Hepatic Enzymes Incidence:
1.0%*
Severity: MODERATE
Onset: DELAYED
Low Lymphocytes Incidence:
1.7%*
Severity: MODERATE
Onset: DELAYED
Itching Incidence:
2.0%*
Severity: MILD
Onset: RAPID
Dry Mouth Incidence:
2.8%*
Severity: MILD
Onset: EARLY
Tired Incidence:
2.8%*
Severity: MILD
Onset: EARLY
Cough Incidence:
2.8%*
Severity: MILD
Onset: DELAYED
Anemia Incidence:
2.8%*
Severity: MODERATE
Onset: DELAYED
Metallic Taste Incidence:
2.9-4.1%*
Severity: MILD
Onset: EARLY
Headache Incidence:
5.0-7.6%*
Severity: MILD
Onset: EARLY
Loose Stools Incidence:
6.0-9.0%*
Severity: MILD
Onset: EARLY
Infection Incidence:
11.9-15.9%*
Severity: MILD
Onset: DELAYED
*This is an approximate aggregated range of reported side effects from clinical studies performed on this drug. Your experience with this drug may be different.
Pregnancy & Lactation Information
FIRST Trimester

Class C - Animal studies have shown an adverse effect and there are no adequate and well-controlled studies in pregnant women. OR No animal studies have been conducted and there are no adequate and well-controlled studies in pregnant women.

SECOND Trimester

Class C - Animal studies have shown an adverse effect and there are no adequate and well-controlled studies in pregnant women. OR No animal studies have been conducted and there are no adequate and well-controlled studies in pregnant women.

THIRD Trimester

Class C - Animal studies have shown an adverse effect and there are no adequate and well-controlled studies in pregnant women. OR No animal studies have been conducted and there are no adequate and well-controlled studies in pregnant women.

Lactation

Caution - Not enough information is available to rule out harm to infants when this drug is taken by nursing mothers.


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