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

Label
(click image for full-size original)

Carton

NDC 69452-252-87

Atovaquone Oral Suspension, USP

750 mg/5 mL

Rx only

210 mL

Bionpharma

carton
(click image for full-size original)
ATOVAQUONE atovaquone suspension
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:69452-252
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ATOVAQUONE (ATOVAQUONE) ATOVAQUONE 750 mg in 5 mL
Inactive Ingredients
Ingredient Name Strength
BENZYL ALCOHOL
HYDROCHLORIC ACID
POLOXAMER 188
WATER
SACCHARIN SODIUM
SODIUM HYDROXIDE
XANTHAN GUM
Product Characteristics
Color yellow (opaque yellow) Score
Shape Size
Flavor BERRY (artificial mixed berry-flavored) Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:69452-252-87 1 BOTTLE in 1 CARTON contains a BOTTLE
1 210 mL in 1 BOTTLE This package is contained within the CARTON (69452-252-87)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA212918 06/01/2021
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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