Atovaquone (Page 5 of 5)
16 HOW SUPPLIED/STORAGE AND HANDLING
Atovaquone oral suspension, USP (opaque yellow, artificial mixed berry-flavored) containing 750 mg atovaquone, USP per 5 mL.
Bottle of 210 mL with child-resistant cap (NDC 69452-252-87). Store at 20° to 25°C (68° to 77°F); excursions permitted between 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Do not freeze. Dispense in tight container as defined in USP.
17 PATIENT COUNSELING INFORMATION
Administration Instructions
Instruct patients to:
- Ensure the prescribed dose of atovaquone oral suspension is taken as directed.
- Take their daily doses of atovaquone oral suspension with food, as food will significantly improve the absorption of the drug.
- Shake atovaquone oral suspension gently before use each time.
Lactation
Instruct mothers with HIV-1-infection not to breastfeed because HIV-1 can be passed to the baby in the breast milk [see Use in Specific Populations ( 8.2)] .
Distributed by:
Bionpharma Inc.
Princeton, NJ 08540
April 2023
FDA-04
PRINCIPAL DISPLAY PANEL — Label
Label
NDC 69452-252-87
Atovaquone Oral Suspension, USP
750 mg/5 mL
Rx only
210 mL
Bionpharma
Carton
NDC 69452-252-87
Atovaquone Oral Suspension, USP
750 mg/5 mL
Rx only
210 mL
Bionpharma
ATOVAQUONE atovaquone suspension | ||||||||||||||||||
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Labeler — Bionpharma Inc. (079637826) |
Establishment | |||
Name | Address | ID/FEI | Operations |
CoreRx Inc. | 780516717 | manufacture (69452-252) |
Revised: 12/2023 Bionpharma Inc.
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