ZOFRAN- ondansetron hydrochloride solution 
GlaxoSmithKline Inc

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Principal Display Panel

NDC 0173-0489-00

Zofran®

(ondansetron hydrochloride)

Oral Solution

4 mg / 5 mL

Rx only

50 mL

Each 5 mL contains 5 mg of ondansetron HCl dihydrate equivalent to 4 mg of ondansetron.

See package insert for Dosage and Administration.

Store between 15o and 30oC (59o and 86oF). Protect from light. Store bottle upright in carton.

GlaxoSmithKline

Research Triangle Park, NC 27709

Made in Canada

A023146 Rev. 1/06

ZOFRAN Oral Solution Label Image - 4mg/5mL
ZOFRAN 
ondansetron hydrochloride solution
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:53873-035
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ONDANSETRON HYDROCHLORIDE (UNII: NMH84OZK2B) (ONDANSETRON - UNII:4AF302ESOS) ONDANSETRON4 mg  in 5 mL
Inactive Ingredients
Ingredient NameStrength
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
WATER (UNII: 059QF0KO0R)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)  
SORBITOL (UNII: 506T60A25R)  
Product Characteristics
ColorYELLOW (clear, colorless to light yellow) Score    
ShapeSize
FlavorSTRAWBERRYImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:53873-035-0050 mL in 1 BOTTLE, GLASS; Type 0: Not a Combination Product02/05/1997
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
Approved Drug Product Manufactured Under ContractNDA02060502/05/1997
Labeler - GlaxoSmithKline Inc (205556368)

Revised: 12/2017
Document Id: 5feffa7f-1a41-424e-a904-4b91022e1c92
Set id: b843449a-f1d7-4c13-808a-6fc3ef9af1d3
Version: 2
Effective Time: 20171212
 
GlaxoSmithKline Inc