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 51407-642-87). 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

Marketed by:

GSMS, Inc.

Camarillo, CA 93012 USA

PRINCIPAL DISPLAY PANEL — Label

Label

NDC 51407-642-87

Atovaquone Oral Suspension, USP

750 mg/5 mL

Rx only

210 mL

//medlibrary.org/lib/images-rx/atovaquone-5/51407-642-87ol-300x101.jpg
(click image for full-size original)

Carton

NDC 51407-642-87

Atovaquone Oral Suspension, USP

750 mg/5 mL

Rx only

210 mL

//medlibrary.org/lib/images-rx/atovaquone-5/51407-642-87cb-282x300.jpg
(click image for full-size original)
ATOVAQUONE atovaquone suspension
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:51407-642(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:51407-642-87 1 BOTTLE in 1 CARTON contains a BOTTLE
1 210 mL in 1 BOTTLE This package is contained within the CARTON (51407-642-87)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA212918 03/30/2021
Labeler — Golden State Medical Supply, Inc. (603184490)
Establishment
Name Address ID/FEI Operations
Golden State Medical Supply, Inc. 603184490 relabel (51407-642), repack (51407-642)

Revised: 02/2024 Golden State Medical Supply, Inc.

All MedLibrary.org resources are included in as near-original form as possible, meaning that the information from the original provider has been rendered here with only typographical or stylistic modifications and not with any substantive alterations of content, meaning or intent.

This site is provided for educational and informational purposes only, in accordance with our Terms of Use, and is not intended as a substitute for the advice of a medical doctor, nurse, nurse practitioner or other qualified health professional.

Privacy Policy | Copyright © 2024. All Rights Reserved.