Fluoxetine (Page 14 of 14)

PRINCIPAL DISPLAY PANEL — 120 mL Bottle Label

NDC 0121-0721-04

Fluoxetine
Oral Solution USP

20 mg/5 mL

PHARMACIST:

Provide accompanying Medication Guide to patient or caregiver a the time of dispensing.

Rx ONLY

120 mL

Pharmaceutical
Associates, Inc. Greenville, SC 29605

PRINCIPAL DISPLAY PANEL — 5 mL Cup Label

F luoxetine
O ral S olution USP

20 mg per 5 mL

Rx ONLY

120 mL

Package Not Child-Resistant

Pharmaceutical
Associates, Inc. Greenville, SC 29605

FLUOXETINE fluoxetine hydrochloride solution

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0121-0721 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength FLUOXETINE HYDROCHLORIDE (FLUOXETINE) FLUOXETINE 20 mg in 5 mL

Inactive Ingredients Ingredient Name Strength GLYCERIN SODIUM BENZOATE SUCROSE SODIUM HYDROXIDE HYDROCHLORIC ACID

Product Characteristics Color yellow (Pale) Score Shape Size Flavor SPEARMINT Imprint Code Contains

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:0121-0721-04 120 mL in 1 BOTTLE None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA076015 01/30/2002

FLUOXETINE fluoxetine hydrochloride solution

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0121-4721 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength FLUOXETINE HYDROCHLORIDE (FLUOXETINE) FLUOXETINE 20 mg in 5 mL

Inactive Ingredients Ingredient Name Strength SODIUM BENZOATE GLYCERIN WATER SUCROSE HYDROCHLORIC ACID SODIUM HYDROXIDE

Product Characteristics Color yellow (Pale) Score Shape Size Flavor SPEARMINT Imprint Code Contains

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:0121-4721-40 4 TRAY in 1 CASE contains a TRAY 1 10 CUP, UNIT-DOSE in 1 TRAY This package is contained within the CASE (0121-4721-40) and contains a CUP, UNIT-DOSE (0121-4721-05) 1 NDC:0121-4721-05 5 mL in 1 CUP, UNIT-DOSE This package is contained within a TRAY and a CASE (0121-4721-40)

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA076015 02/01/2002

Labeler — Pharmaceutical Associates, Inc. (044940096)

Establishment
Name	Address	ID/FEI	Operations
Pharmaceutical Associates, Inc.		097630693	manufacture (0121-0721), manufacture (0121-4721)

Revised: 06/2022 Pharmaceutical Associates, Inc.