Label: PROMETHAZINE HCL injection, solution
-
Contains inactivated NDC Code(s)
NDC Code(s): 52533-204-12 - Packager: Cantrell Drug Company
- Category: HUMAN PRESCRIPTION DRUG LABEL
- DEA Schedule: None
- Marketing Status: unapproved drug other
DISCLAIMER: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.
Drug Label Information
Updated May 27, 2014
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- PRINCIPAL DISPLAY PANEL
- SPL UNCLASSIFIED SECTION
-
INGREDIENTS AND APPEARANCE
PROMETHAZINE HCL
promethazine hcl injection, solutionProduct 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)
