Amantadine Oral Solution USP

Name: Amantadine Oral Solution USP

Package/label prinicpal display panel

AMANTADINE HYDROCHLORIDE ORAL SOLUTION, USP

50 mg/ 5 mL

 

Each teaspoonful (5 mL) contains:

Amantadine Hydrochloride, USP ...... 50 mg

USUAL DOSAGE: See package insert for full prescribing information.

Dispense in a tight, light-resistant container as defined in the USP.

Keep tightly closed. Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature].

16 fl oz (473 mL)

HI-TECH PHARMACAL CO., INC.

AMITYVILLE, NY 11701

AMANTADINE HYDROCHLORIDE 
amantadine hydrochloride solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:50383-807
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
AMANTADINE HYDROCHLORIDE (AMANTADINE) AMANTADINE HYDROCHLORIDE 50 mg  in 5 mL
Inactive Ingredients
Ingredient Name Strength
ANHYDROUS CITRIC ACID  
METHYLPARABEN  
PROPYLPARABEN  
WATER  
SORBITOL  
Product Characteristics
Color      Score     
Shape Size
Flavor RASPBERRY (artificial) Imprint Code
Contains     
Packaging
# Item Code Package Description
1 NDC:50383-807-16 473 mL in 1 BOTTLE
2 NDC:50383-807-12 10 TRAY in 1 CASE
2 10 CUP, UNIT-DOSE in 1 TRAY
2 NDC:50383-807-10 10 mL in 1 CUP, UNIT-DOSE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA074170 10/28/1994
Labeler - Hi-Tech Pharmacal Co., Inc. (101196749)
Revised: 01/2015   Hi-Tech Pharmacal Co., Inc.
(web3)