PHENOBARBITAL WITH BELLADONNA ALKALOIDS (Page 2 of 2)

​Principal Display Panel

NDC 71914-162-04

​PHENOBARBITAL

​with

​BELLADONNA

​ALKALOIDS

​ELIXIR

4 oz. Bottle

Rx Only

container-label-4oz
(click image for full-size original)

NDC 71914-162-16

​PHENOBARBITAL

​with

​BELLADONNA

​ALKALOIDS

​ELIXIR

16 oz. Bottle

Rx Only

container-label-16oz
(click image for full-size original)

NDC 71914-162-10

​PHENOBARBITAL

​with

BELLADONNA

ALKALOIDS

ELIXIR

​Ten 5 mL Cups

Rx Only

image description
(click image for full-size original)
PHENOBARBITAL WITH BELLADONNA ALKALOIDS
phenobarbital with belladonna alkaloids elixir
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:71914-162
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 .0065 mg in 5 mL
Inactive Ingredients
Ingredient Name Strength
ALCOHOL
WATER
GLYCERIN
METHYLPARABEN SODIUM
PROPYLPARABEN SODIUM
SACCHARIN SODIUM
XYLITOL
CITRIC ACID MONOHYDRATE
REBAUDIOSIDE A
Product Characteristics
Color purple Score
Shape Size
Flavor grape Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:71914-162-04 120 mL in 1 BOTTLE None
2 NDC:71914-162-16 473 mL in 1 BOTTLE None
3 NDC:71914-162-01 5 mL in 1 CUP, UNIT-DOSE None
4 NDC:71914-162-10 1 TRAY in 1 CASE contains a TRAY
4 10 CUP, UNIT-DOSE in 1 TRAY This package is contained within the CASE (71914-162-10) and contains a CUP, UNIT-DOSE (71914-162-01)
4 NDC:71914-162-01 5 mL in 1 CUP, UNIT-DOSE This package is contained within a TRAY and a CASE (71914-162-10)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved drug other 04/20/2018 07/29/2021
Labeler — Lazarus Pharmaceuticals, Inc. (080957284)

Revised: 07/2021 Lazarus Pharmaceuticals, Inc.

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