Label: NEO-SYNEPHRINE HYDROCHLORIDE- phenylephrine hydrochloride injection, solution
- NDC Code(s): 0409-1800-01
- Packager: Hospira, Inc.
- Category: HUMAN PRESCRIPTION DRUG LABEL
- DEA Schedule: None
- Marketing Status: Export only
Drug Label Information
Updated January 13, 2021
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- PRINCIPAL DISPLAY PANEL - 1 mL Ampule Label
-
PRINCIPAL DISPLAY PANEL - 1 mL Ampule Cello Pack Label
1 mL (10 mg)
Single-dose
5 Ampuls
NDC 0409-1800-01Neo-Synephrine® HCl
phenylephrine hydrochloride injection, USP
1% Sterile Aqueous InjectionFOR PARENTERAL USE
Rx onlyPROTECT 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
HospiraRL-2067 (3/07)
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INGREDIENTS AND APPEARANCE
NEO-SYNEPHRINE HYDROCHLORIDE
phenylephrine hydrochloride injection, solutionProduct 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)
