PROMETHAZINE HCL- promethazine hcl injection, solution 
Cantrell Drug Company

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.

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Promethazine HCl 0.625 mg/mL in 0.9% Sodium Chloride 10 mL Syringe

Label

PROMETHAZINE HCL 
promethazine hcl injection, solution
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:52533-204
Route of AdministrationINTRAVENOUS
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
PROMETHAZINE HYDROCHLORIDE (UNII: R61ZEH7I1I) (PROMETHAZINE - UNII:FF28EJQ494) PROMETHAZINE HYDROCHLORIDE0.625 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
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 KindIngredient NameQuantity
May containACETIC ACID (UNII: Q40Q9N063P)  
May containSODIUM ACETATE (UNII: 4550K0SC9B)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:52533-204-1210 mL in 1 SYRINGE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other05/27/2014
Labeler - Cantrell Drug Company (035545763)

Revised: 5/2014
Document Id: 40c4811d-3088-40ee-9c7b-beb57813276d
Set id: 600b20fd-a47b-42cd-bec5-b249f88742c4
Version: 1
Effective Time: 20140527
 
Cantrell Drug Company