Prometh with Codeine (Page 5 of 5)

Principal Display Panel

Prometh/Cod 6.25/10mg
(click image for full-size original)

PROMETH WITH CODEINE
promethazine hydrochloride and codeine phosphate syrup
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:42254-140(NDC:0472-1627)
Route of Administration ORAL DEA Schedule CV
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Promethazine Hydrochloride (Promethazine) Promethazine Hydrochloride 6.25 mg in 5 mL
Codeine Phosphate (Codeine) Codeine Phosphate 10 mg in 5 mL
Inactive Ingredients
Ingredient Name Strength
CITRIC ACID MONOHYDRATE
corn syrup
D&C RED NO. 33
FD&C BLUE NO. 1
METHYLPARABEN
propylene glycol
propylparaben
WATER
SACCHARIN SODIUM DIHYDRATE
sodium benzoate
sodium citrate
alcohol
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:42254-140-04 118 mL in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA088763 10/31/1984
Labeler — Rebel Distributors Corp (118802834)
Establishment
Name Address ID/FEI Operations
Rebel Distributors Corp 118802834 RELABEL, REPACK

Revised: 01/2012 Rebel Distributors Corp

All MedLibrary.org resources are included in as near-original form as possible, meaning that the information from the original provider has been rendered here with only typographical or stylistic modifications and not with any substantive alterations of content, meaning or intent.

This site is provided for educational and informational purposes only, in accordance with our Terms of Use, and is not intended as a substitute for the advice of a medical doctor, nurse, nurse practitioner or other qualified health professional.

Privacy Policy | Copyright © 2020. All Rights Reserved.