RE-PB HYOS ELIXIR (Page 2 of 2)

Principal Display Panel

Belladonna Phenobarbital
(click image for full-size original)

RE-PB HYOS ELIXIR belladonna alkaloids w/ phenobarbital elixir
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:21695-594(NDC:68032-395)
Route of Administration ORAL DEA Schedule CIV
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
PHENOBARBITAL (PHENOBARBITAL) PHENOBARBITAL 16.2 mg in 5 mL
HYOSCYAMINE SULFATE (HYOSCYAMINE) HYOSCYAMINE SULFATE 0.1037 mg in 5 mL
ATROPINE SULFATE (ATROPINE) ATROPINE SULFATE 0.0194 mg in 5 mL
SCOPOLAMINE HYDROBROMIDE (SCOPOLAMINE) SCOPOLAMINE HYDROBROMIDE 0.0065 mg in 5 mL
Inactive Ingredients
Ingredient Name Strength
ALCOHOL
FD&C RED NO. 40
GLYCERIN
WATER
SACCHARIN SODIUM
SORBITOL
SUCROSE
Product Characteristics
Color purple Score
Shape Size
Flavor GRAPE Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:21695-594-16 480 mL in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
Unapproved drug other 10/20/2009
Labeler — Rebel Distributors Corp (118802834)
Establishment
Name Address ID/FEI Operations
Rebel Distributors Corp 118802834 RELABEL, REPACK

Revised: 01/2011 Rebel Distributors Corp

Page 2 of 2 1 2

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 © 2024. All Rights Reserved.