CHILDREN - The usual subcutaneous or intramuscular dose is 0.5 mg/kg of body weight or 16.7 mg/square meter of body surface every 4 to 6 hours.

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.

HOW SUPPLIED

Ephedrine Sulfate Injection USP, 50 mg/mL

1 mL ampules in packs of 10, NDC 17478-515-00
STORAGE: Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Protect from light.

Akorn
Manufactured by: Akorn, Inc.
Lake Forest, IL 60045

ES00N
Rev. 03/10 
PRINCIPAL DISPLAY PANEL

Principal Display Panel Text for Container Label:

NDC 17478-515-00

Ephedrine Sulfate

Injection, USP

50 mg/mL

1 mL Single Dose Ampule

For IM, IV, or SC use

Mfd. by:

Rx only Akorn, Inc.
 
PRINCIPAL DISPLAY PANEL

Principal Display Panel Text for Carton Label:

NDC 17478-515-00

Ephedrine Sulfate Injection, USP

50 mg/mL

For IM, IV, or SC use

1 mL Single Dose Ampules

10 Ampules (1 mL each)

Rx only Akorn
INGREDIENTS AND APPEARANCE
EPHEDRINE SULFATE 
ephedrine sulfate injection
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:17478-515
Route of Administration INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Ephedrine Sulfate (UNII: U6X61U5ZEG) (Ephedrine - UNII:GN83C131XS) Ephedrine Sulfate 50 mg  in 1 mL
Inactive Ingredients
Ingredient Name Strength
WATER (UNII: 059QF0KO0R)  
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:17478-515-00 10 in 1 CARTON  
1  1 mL in 1 AMPULE  
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved drug other  04/01/2009 
Labeler - Akorn, Inc. (062649876) 
Establishment
Name Address ID/FEI Business Operations
Akorn, Inc.  155135783 MANUFACTURE, REPACK, ANALYSIS, LABEL, PACK, RELABEL, STERILIZE