Atovaquone (Page 4 of 4)

16 HOW SUPPLIED/STORAGE AND HANDLING

Atovaquone oral suspension, USP is a yellow homogenous suspension containing 750 mg atovaquone USP per 5 mL.

18 cups x 5 mL (750 mg/ 5mL), NDC 0904-7064-25

42 cups x 5 mL (750 mg/ 5mL), NDC 0904-7064-53

Store at 15° to 25°C (59° to 77°F). 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.

Manufactured for:
Camber Pharmaceuticals, Inc.
Piscataway, NJ 08854
By: HETERO^TM
HETERO LABS LIMITED 204961
Jeedimetla, Hyderabad – 500 055, India. Distributed By:

MAJOR® PHARMACEUTICALS

17177 N Laurel Park Dr., Suite 233

Livonia, MI 48152

Revised: June 2018

PACKAGE/LABEL PRINCIPAL DISPLAY PANEL

Atovaquone Oral Suspension, USP

750 mg/5mL

ATOVAQUONE atovaquone suspension

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0904-7064(NDC:31722-629) 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 XANTHAN GUM POLOXAMER 188 WATER HYPROMELLOSE 2910 (3 MPA.S) SACCHARIN SODIUM

Product Characteristics Color YELLOW Score Shape Size Flavor STRAWBERRY Imprint Code Contains

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:0904-7064-25 18 CUP in 1 CARTON contains a CUP (0904-7064-41) 1 NDC:0904-7064-41 5 mL in 1 CUP This package is contained within the CARTON (0904-7064-25) 2 NDC:0904-7064-53 42 CUP in 1 CASE contains a CUP (0904-7064-41) 2 NDC:0904-7064-41 5 mL in 1 CUP This package is contained within the CASE (0904-7064-53)

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA210692 10/11/2018

Labeler — Major Pharmaceuticals (191427277)

Revised: 12/2020 Major Pharmaceuticals