PROMETHAZINE HCL injection, solution

Promethazine HCl by

Drug Labeling and Warnings

Promethazine HCl by is a Prescription medication manufactured, distributed, or labeled by Cantrell Drug Company. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

PRINCIPAL DISPLAY PANEL

SPL UNCLASSIFIED SECTION

INGREDIENTS AND APPEARANCE

PROMETHAZINE HCL 
promethazine hcl injection, solution

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC: 52533-204
Route of Administration	INTRAVENOUS

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
PROMETHAZINE HYDROCHLORIDE (UNII: R61ZEH7I1I) (PROMETHAZINE - UNII:FF28EJQ494)	PROMETHAZINE HYDROCHLORIDE	0.625 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
SODIUM CHLORIDE (UNII: 451W47IQ8X)	9 mg  in 1 mL
EDETATE SODIUM (UNII: MP1J8420LU)	0.013 mg  in 1 mL
CALCIUM CHLORIDE (UNII: M4I0D6VV5M)	0.005 mg  in 1 mL
SODIUM METABISULFITE (UNII: 4VON5FNS3C)	0.03 mg  in 1 mL
PHENOL (UNII: 339NCG44TV)	0.6375 mg  in 1 mL
WATER (UNII: 059QF0KO0R)

Other Ingredients
Ingredient Kind	Ingredient Name	Quantity
May contain	ACETIC ACID (UNII: Q40Q9N063P)
May contain	SODIUM ACETATE (UNII: 4550K0SC9B)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 52533-204-12	10 mL in 1 SYRINGE, PLASTIC

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		05/27/2014

Labeler - Cantrell Drug Company (035545763)