Fluconazole OS / 40 mg/mL / 35 mL bottle

Fluconazole OS

40 mg/mL / 35 mL bottle
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Brand name: DiFlucan®

1. Oropharyngeal and esophageal candidiasis. In open noncomparative studies of relatively small numbers of patients, fluconazole for oral suspension USP was also effective for the treatment of Candida urinary tract infections, peritonitis, and systemic Candida infections including candidemia, disseminated candidiasis, and pneumonia.

2. Cryptococcal meningitis. Before prescribing fluconazole for oral suspension USP for AIDS patients with cryptococcal meningitis, please see CLINICAL STUDIES section. Studies comparing fluconazole for oral suspension USP to amphotericin B in non-HIV infected patients have not been conducted.
Prophylaxis. Fluconazole for oral suspension USP is also indicated to decrease the incidence of candidiasis in patients undergoing bone marrow transplantation who receive cytotoxic chemotherapy and/or radiation therapy.

For more information please see the prescribing information.

For more information please see the prescribing information on DailyMed.

Product Information
Product Name Fluconazole OS
Strength 40 mg/mL
Strength 40 mg/mL
Dosage Form Powder for Oral Suspension
Pack Size 35 mL bottle
NDC 57237-150-35
OTC/Rx Rx
TE Code AB
Product Characteristics
Color white to off-white powder
Shape N/A
Gluten Free from Gluten
Lactose Free from Lactose
Sweeteners Contains Sucrose
Soy Free from Soy
Gelatin Free from Gelatin
Allergen Info Not Applicable
Other Product Info Not Applicable
Other Information
Inactive Ingredients

sodium benzoate, citric acid anhydrous, sodium citrate, xanthan gum, titanium dioxide, natural orange flavor, colloidal silicon dioxide, and sucrose

Imprint/Markings N/A
Special Instructions

Before Reconstitution: Store dry powder at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. After Reconstitution: Store reconstituted suspension between 5°C (41°F) and 25°C (77°F). Protect from freezing. Discard unused portion after 2 weeks.

Product Shelf Life 24 months

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