NEO-SYNEPHRINE HYDROCHLORIDE- phenylephrine hydrochloride injection, solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV)

Available from:

Hospira, Inc.

INN (International Name):

PHENYLEPHRINE HYDROCHLORIDE

Composition:

PHENYLEPHRINE HYDROCHLORIDE 10 mg in 1 mL

Administration route:

SUBCUTANEOUS

Prescription type:

PRESCRIPTION DRUG

Authorization status:

Export only

Summary of Product characteristics

NEO-SYNEPHRINE HYDROCHLORIDE- PHENYLEPHRINE HYDROCHLORIDE INJECTION,
SOLUTION
HOSPIRA, INC.
----------
NEO-SYNEPHRINE HCL
PRINCIPAL DISPLAY PANEL - 1 ML AMPULE LABEL
1 mL
NDC 0409-1800-01
Neo-Synephrine
HCl
Rx only
phenylephrine HCl
injection, USP
10 mg/mL
1% Solution
Hospira, Inc.
Lake Forest, IL 60045 USA
RL-1423 (11/05)
®
®
PRINCIPAL DISPLAY PANEL - 1 ML AMPULE CELLO PACK 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)
NEO-SYNEPHRINE HYDROCHLORIDE
phenylephrine hydrochloride injection, solution
PRODUCT INFORMATION
PRODUCT T YPE
HUMAN PRESCRIPTION DRUG
ITE M CODE
(S OURCE )
NDC:0 40 9 -
18 0 0
ROUTE OF ADMINISTRATION
SUBCUTANEOUS, INTRAMUSCULAR,
INTRAVENOUS
ACTIVE INGREDIENT/ACTIVE MOIETY
INGREDIENT NAME
BASIS OF STRENGTH
STRE NG TH
PHENYLEPHRINE HYDRO CHLO RIDE (UNII: 0 4JA59 TNSJ) (PHENYLEPHRINE -
PHENYLEPHRINE
10 mg
Hospira, Inc.
UNII:1WS29 7W6 MV)
HYDROCHLORIDE
in 1 mL
INACTIVE INGREDIENTS
INGREDIENT NAME
STRE NG TH
SO DIUM CHLO RIDE (UNII: 451W47IQ8 X)
3.5 mg in 1 mL
SO DIUM CITRATE, UNSPECIFIED FO RM (UNII: 1Q73Q2JULR)
4 mg in 1 mL
CITRIC ACID MO NO HYDRATE (UNII: 29 6 8 PHW8 QP)
1 mg in 1 mL
SO DIUM METABISULFITE (UNII: 4VON5FNS3C)
PACKAG ING
#
ITEM CODE
PACKAGE DESCRIPTION
MARKETING START DATE
MARKETING END DATE
1
NDC:0 40 9 -18 0 0 -0 1
5 in 1 CELLO PACK
0 3/14/20 0 6
1
1 mL in 1 AMPULE; Type 0 : No t a Co mbinatio n Pro duct
MARKETING INFORMATION
MARKE TING CATE GORY
APPLICATION NUMBE