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)

PRINCIPAL DISPLAY PANEL -- 30 mL Bottle
(click image for full-size original)
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

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