DICOPANOL- diphenhydramine hydrochloride kit

Dicopanol by

Drug Labeling and Warnings

Dicopanol by is a Prescription medication manufactured, distributed, or labeled by California Pharmaceuticals LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Dicopanol, Instructions for Use, Page 2

Instructions for Preparation - page 1

Diphenhydramine - label

Dicopanol. Package Label

Dicopanol - Flavor Suspension label

INGREDIENTS AND APPEARANCE

DICOPANOL 
diphenhydramine hydrochloride kit

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC: 70332-103

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70332-103-01	1 in 1 KIT

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

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M)	DIPHENHYDRAMINE HYDROCHLORIDE	0.86 g  in 0.86 g

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1		0.75 g in 1 BOTTLE, GLASS; Type 0: Not a Combination Product

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

Inactive Ingredients
Ingredient Name	Strength
SODIUM CITRATE (UNII: 1Q73Q2JULR)
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
XYLITOL (UNII: VCQ006KQ1E)
GLYCYRRHIZIN, AMMONIATED (UNII: 3VRD35U26C)
PINEAPPLE (UNII: 2A88ZO081O)
XANTHAN GUM (UNII: TTV12P4NEE)
SODIUM BENZOATE (UNII: OJ245FE5EU)
ORANGE (UNII: 5EVU04N5QU)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
MELATONIN (UNII: JL5DK93RCL)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
STEVIA LEAF (UNII: 6TC6NN0876)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1		150 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product

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	Business Operations
California Pharmaceuticals LLC		021420944	manufacture(70332-103)