PHENYLEPHRINE HYDROCHLORIDE injection

Phenylephrine Hydrochloride by

Drug Labeling and Warnings

Phenylephrine Hydrochloride by is a Prescription medication manufactured, distributed, or labeled by Assure Infusions, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Storgae and Handling Section

See package insert for complete warnings and directions. Store at 20-25C (68F to 77F). Protect from light.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

PHENYLEPHRINE HYDROCHLORIDE 
phenylephrine hydrochloride injection

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC: 83155-108
Route of Administration	INTRAVENOUS

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
PHENYLEPHRINE HYDROCHLORIDE, (+/-)- (UNII: O2VT86KV7E) (PHENYLEPHRINE HYDROCHLORIDE, (+/-)- - UNII:O2VT86KV7E)	PHENYLEPHRINE HYDROCHLORIDE, (+/-)-	20 mg  in 250 mL

Inactive Ingredients
Ingredient Name	Strength
SODIUM CHLORIDE NA-22 (UNII: VMP9781061)	1875 mg  in 250 mL
TRISODIUM CITRATE DIHYDRATE (UNII: B22547B95K)	1000 mg  in 250 mL
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)	250 mg  in 250 mL

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 83155-108-25	250 mL in 1 CONTAINER; Type 0: Not a Combination Product	03/20/2026

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		03/20/2026

Labeler - Assure Infusions, Inc. (053016941)

Registrant - Assure Infusions, Inc. (053016941)

Establishment
Name	Address	ID/FEI	Business Operations
Assure Infusions, Inc.		053016941	manufacture(83155-108)