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 -- 120 mL Bottle Label
(click image for full-size original)

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

Principal Display Panel -- 5 mL Cup Label
(click image for full-size original)

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.

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