Usual Adult Dosage: 50 mg (2 mL) every 6 to 8 hours.

See package insert for Dosage and Administration.

Store between 4o and 25oC (39o and 77oF); excursions permitted to 30oC (86oF).

Protect from light.

Zantac® Injection tends to exhibit a yellow color that may intensify over time without adversely affecting potency.

*Each 1 mL of aqueous solution contains ranitidine 25 mg (as the hydrochloride); phenol 5 mg as preservative; monobasic potassium phosphate and dibasic sodium phosphate as buffers.

Zantac is a registered trademark of Warner-Lambert Company, used under license.

GlaxoSmithKline

Research Triangle Park, NC 27709

Made in England

NDC 0173-0441-00

Zantac® Injection Premixed

(ranitidine hydrochloride)

50 mg in 50 mL*

*50 mg ranitidine (as the hydrochloride) per 50 mL in 0.45% sodium chloride. Sterile, single-dose flexible plastic container. Nonpyrogenic. Contains no preservative. See package insert.

Store between 2o and 25oC (36o and 77oF). Protect from light. Avoid excessive heat. See package insert. Protect from freezing. Additives should not be made to this solution. Do not remove unit from overwrap until ready for use. Visually inspect overwrap for tears or holes. Discard unit if overwrap is damaged. Use unit promptly when overwrap is opened. After removing the overwrap, check for minute leaks by squeezing container firmly. If leaks are found, discard unit as sterility may be impaired. Use only if solution is clear. Must not be used in series connections.

Rx only

TO OPEN - TEAR AT NOTCH

Zantac is a registered trademark of Warner-Lambert Company, used under license.

Manufactured for GlaxoSmithKline

Research Triangle Park, NC 27709

By Hospira, Inc.

Lake Forest, IL 60045

Made in Singapore

F WR-0278(4/08) A054600

ZANTAC 
ranitidine hydrochloride   injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 0173-0362
Route of Administration INTRAVENOUS, INTRAMUSCULAR DEA Schedule      
 
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
RANITIDINE HYDROCHLORIDE (RANITIDINE)  RANITIDINE HYDROCHLORIDE 25 mg  in 1 mL
 
Inactive Ingredients
Ingredient Name Strength
PHENOL  
POTASSIUM PHOSPHATE, MONOBASIC  
SODIUM PHOSPHATE, DIBASIC  
 
Product Characteristics
Color YELLOW (colorless to yellow)  Score     
Shape  Size 
Flavor  Imprint Code 
Contains     
 
Packaging
# NDC Package Description Multilevel Packaging
1 0173-0362-38 10 VIAL In 1 CARTON contains a VIAL
1  2 mL In 1 VIAL This package is contained within the CARTON (0173-0362-38)
 
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA019090 10/01/1989 

ZANTAC 
ranitidine hydrochloride   injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 0173-0363
Route of Administration INTRAVENOUS, INTRAMUSCULAR DEA Schedule