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.
• Bottle of 210 mL with child-resistant cap (NDC 31722-629-21). 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.

address1

Manufactured for:
Camber Pharmaceuticals, Inc.
Piscataway, NJ 08854
By: HETEROTM
HETERO LABS LIMITED 204961
Jeedimetla, Hyderabad – 500 055, India. Revised: June 2018

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Atovaquone Oral Suspension, USP 750 mg/5 mL Container Label

atovaquoneoscontlabel
(click image for full-size original)

Atovaquone Oral Suspension, USP 750 mg/5 mL Carton Label

atovaquoneoscartonlabel
(click image for full-size original)
ATOVAQUONE atovaquone suspension
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) 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:31722-629-21 1 BOTTLE in 1 CARTON contains a BOTTLE
1 210 mL in 1 BOTTLE This package is contained within the CARTON (31722-629-21)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA210692 10/11/2018
Labeler — Camber Pharmaceuticals, Inc. (826774775)
Establishment
Name Address ID/FEI Operations
Hetero Labs Limited Unit III 676162024 ANALYSIS (31722-629), MANUFACTURE (31722-629)

Revised: 10/2018 Camber Pharmaceuticals, Inc.

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