Baycadron (Page 3 of 3)

HOW SUPPLIED

Baycadron™ Elixir (Dexamethasone Elixir, USP 0.5 mg/5 mL) is supplied as a clear, red, raspberry-flavored liquid in the following size:

8 fl oz (No Dropper) (237 mL)

RECOMMENDED STORAGE

Store at 20° to 25°C (68° to 77°F). [See USP Controlled RoomTemperature].

KEEP TIGHTLY CLOSED

AVOID FREEZING

Dispense in a tight container as defined in the USP.

Rx Only

Product No.: 8810

Manufactured For:
Wockhardt USA, LLC
Parsippany, NJ 07054

Manufactured By:
Morton Grove Pharmaceuticals, Inc.
Morton Grove, IL 60053

28810
ISS. 12-08

PRINCIPAL DISPLAY PANEL — 30 mL Bottle

WOCKHARDT

NDC 64679-810-30

BAYCADRON™
ELIXIR

(Dexamethasone Elixir,
USP 0.5 mg/5 mL)

PROFESSIONAL SAMPLE – NOT FOR RESALE

Rx Only

NET: 1 fl oz (30 mL)

BAYCADRON dexamethasone elixir

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:64679-810 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Dexamethasone (Dexamethasone) Dexamethasone 0.5 mg in 5 mL

Inactive Ingredients Ingredient Name Strength raw sugar propylene glycol benzoic acid alcohol Anhydrous Citric Acid FD&C red no. 40 water sodium citrate citric acid monohydrate

Product Characteristics Color RED (Clear) Score Shape Size Flavor RASPBERRY Imprint Code Contains

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:64679-810-08 30 mL in 1 BOTTLE None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA088254 07/27/1983

Labeler — Wockhardt USA, LLC (170508365)

Revised: 07/2009 Wockhardt USA, LLC