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Neo-Synephrine® HCl(phenylephrine hydrochloride injection, USP
2017-10-08 08:33:49 来源: 作者: 【 】 浏览:584次 评论:0

PRINCIPAL DISPLAY PANEL - 1 mL Ampule Label

1 mL (10 mg)
Single-dose
5 Ampuls
NDC 0409-1800-01

Neo-Synephrine® HCl
phenylephrine hydrochloride injection, USP
1% Sterile Aqueous Injection

FOR PARENTERAL USE
Rx only

PROTECT FROM LIGHT.

Each mL contains 10 mg NEO-SYNEPHRINE hydrochloride,
brand of phenylephrine hydrochloride, 3.5 mg sodium
chloride, 4 mg sodium citrate, 1 mg citric acid monohydrate,
and not more than 2 mg sodium metabisulfite as preservative.
For usual dosage and route of administration, see package
insert. Store at 20 to 25°C (68 to 77°F). [See USP Controlled
Room Temperature.]
WARNING: CONTAINS SULFITES.

Printed in USA
Hospira, Inc., Lake Forest, IL 60045 USA
Hospira

RL-2067 (3/07)

PRINCIPAL DISPLAY PANEL - 1 mL Ampule Label

INGREDIENTS AND APPEARANCE

 

NEO-SYNEPHRINE HYDROCHLORIDE  phenylephrine hydrochloride injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0409-1800
Route of Administration SUBCUTANEOUS, INTRAMUSCULAR, INTRAVENOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE 10 mg  in 1 mL
Inactive Ingredients
Ingredient Name Strength
SODIUM CHLORIDE (UNII: 451W47IQ8X) 3.5 mg  in 1 mL
SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR) 4 mg  in 1 mL
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) 1 mg  in 1 mL
SODIUM METABISULFITE (UNII: 4VON5FNS3C)  
 
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0409-1800-01 5 in 1 CELLO PACK 03/14/2006  
1   1 mL in 1 AMPULE; Type 0: Not a Combination Product    
 
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
EXPORT ONLY   03/14/2006  
Labeler - Hospira, Inc. (141588017)
Establishment
Name Address ID/FEI Business Operations
Hospira, Inc.   093132819 ANALYSIS(0409-1800) , LABEL(0409-1800) , MANUFACTURE(0409-1800) , PACK(0409-1800)
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