Dicopanol

DICOPANOL- diphenhydramine hydrochloride
California Pharmaceuticals LLC

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.

Dicopanol, Instructions for Use, Page 2

Dicopanol -- Instructions 2
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Instructions for Preparation — page 1

Dicopanol -- Instructions Page 1
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Diphenhydramine — label

Diphen  label
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Dicopanol. Package Label

Dicopanol -- Principal display label
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Dicopanol — Flavor Suspension label

Dicopanol -- Flavor Suspension label
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DICOPANOL
diphenhydramine hydrochloride kit
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70332-103
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:70332-103-01 1 KIT in 1 KIT None
Quantity of Parts
Part # Package Quantity Total Product Quantity
Part 1 1 BOTTLE, GLASS 0.86 g
Part 2 1 BOTTLE, PLASTIC 150 mL
Part 1 of 2
DIPHENHYDRAMINE HYDROCHLORIDE
diphenhydramine hydrochloride powder, for suspension
Product Information
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DIPHENHYDRAMINE HYDROCHLORIDE (DIPHENHYDRAMINE) DIPHENHYDRAMINE HYDROCHLORIDE 0.86 g in 0.86 g
Packaging
# Item Code Package Description Multilevel Packaging
1 0.75 g in 1 BOTTLE, GLASS None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved drug other 01/01/2016
Part 2 of 2
ORAL SUSPENSION VEHICLE
suspension liquid
Product Information
Route of Administration ORAL DEA Schedule
Inactive Ingredients
Ingredient Name Strength
SODIUM CITRATE
WATER
GLYCERIN
XYLITOL
GLYCYRRHIZIN, AMMONIATED
PINEAPPLE
XANTHAN GUM
SODIUM BENZOATE
ORANGE
CITRIC ACID MONOHYDRATE
MELATONIN
POTASSIUM SORBATE
STEVIA LEAF
Packaging
# Item Code Package Description Multilevel Packaging
1 150 mL in 1 BOTTLE, PLASTIC None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved drug other 01/01/2016
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved drug other 01/01/2016
Labeler — California Pharmaceuticals LLC (021420944)
Registrant — California Pharmaceuticals LLC (021420944)
Establishment
Name Address ID/FEI Operations
California Pharmaceuticals LLC 021420944 manufacture (70332-103)

Revised: 01/2016 California Pharmaceuticals LLC

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