Atovaquone (Page 8 of 8)

16 HOW SUPPLIED/STORAGE AND HANDLING

Atovaquone oral suspension USP is a yellow homogenous suspension containing 750 mg of atovaquone perin 5 mL. Due to the viscous nature of this product, an overage is present in each unit-dose container in order to deliver the 5 mL dose. Gently rock the product back and forth prior to dispensing the product to the patient. The unit dose cup may be poured for up to 15 seconds or a suitable dosing device may be used to extract the 5 mL dose for oral administration.

NDC 0121-0898-05: 5 mL unit dose cup, in a tray of 6 cups.

Store at 20° to 25ºC (68° to 77ºF).

DO NOT FREEZE. Dispense in a 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. The unit dose cup may be poured for up to 15 seconds or a suitable dosing device may be used to extract the 5 mL dose for oral administration.

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)].

PACKAGED BY

Pharmaceutical Associates, Inc.
Greenville, SC 29605
www.paipharma.com

R11/20

PRINCIPAL DISPLAY PANEL — 5 mL Cup Label

Delivers 5 mL
NDC 0121-0898-05

ATOVAQUONE ORAL SUSPENSION USP

750 mg/5 mL

SHAKE GENTLY BEFORE USING.

Rx ONLY
Package Not Child-Resistant

Pkg. by: Pharmaceutical Associates, Inc.
Greenville, SC 29605

PRINCIPAL DISPLAY PANEL — 10 mL Cup Label

Delivers 10 mL
NDC 0121-1796-10

ATOVAQUONE ORAL SUSPENSION USP

1500 mg/10 mL

SHAKE GENTLY BEFORE USING.

Package Not Child-Resistant

Rx ONLY Pkg. by: Pharmaceutical Associates, Inc.

Greenville, SC 29605

ATOVAQUONE atovaquone suspension

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0121-0898(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 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:0121-0898-18 3 TRAY in 1 CASE contains a TRAY 1 6 CUP, UNIT-DOSE in 1 TRAY This package is contained within the CASE (0121-0898-18) and contains a CUP, UNIT-DOSE (0121-0898-05) 1 NDC:0121-0898-05 5 mL in 1 CUP, UNIT-DOSE This package is contained within a TRAY and a CASE (0121-0898-18) 2 NDC:0121-0898-42 7 TRAY in 1 CASE contains a TRAY 2 6 CUP, UNIT-DOSE in 1 TRAY This package is contained within the CASE (0121-0898-42) and contains a CUP, UNIT-DOSE (0121-0898-05) 2 NDC:0121-0898-05 5 mL in 1 CUP, UNIT-DOSE This package is contained within a TRAY and a CASE (0121-0898-42)

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

ATOVAQUONE atovaquone suspension

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0121-1796 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ATOVAQUONE (ATOVAQUONE) ATOVAQUONE 1500 mg in 10 mL

Inactive Ingredients Ingredient Name Strength BENZYL ALCOHOL XANTHAN GUM POLOXAMER 188 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:0121-1796-20 2 TRAY in 1 CASE contains a TRAY 1 10 PACKAGE in 1 TRAY This package is contained within the CASE (0121-1796-20) and contains a PACKAGE (0121-1796-10) 1 NDC:0121-1796-10 10 mL in 1 PACKAGE This package is contained within a TRAY and a CASE (0121-1796-20)

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

Labeler — PAI Holdings, LLC (044940096)

Establishment
Name	Address	ID/FEI	Operations
PAI Holdings, LLC dba Pharmaceutical Associates, Inc.		097630693	label (0121-0898), repack (0121-0898)

Revised: 12/2022 PAI Holdings, LLC