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.

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Dicopanol

Dicopanol, Instructions for Use, Page 2

Dicopanol - Instructions 2

Instructions for Preparation - page 1

Dicopanol - Instructions Page 1

Diphenhydramine - label

Diphen label

Dicopanol. Package Label

Dicopanol - Principal display label

Dicopanol - Flavor Suspension label

Dicopanol - Flavor Suspension label

DICOPANOL 
diphenhydramine hydrochloride kit
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:70332-103
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70332-103-011 in 1 KIT
Quantity of Parts
Part #Package QuantityTotal Product Quantity
Part 11 BOTTLE, GLASS 0.86 g
Part 21 BOTTLE, PLASTIC 150 mL
Part 1 of 2
DIPHENHYDRAMINE HYDROCHLORIDE 
diphenhydramine hydrochloride powder, for suspension
Product Information
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M) DIPHENHYDRAMINE HYDROCHLORIDE0.86 g  in 0.86 g
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
10.75 g in 1 BOTTLE, GLASS; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other01/01/2016
Part 2 of 2
ORAL SUSPENSION VEHICLE 
suspension liquid
Product Information
Route of AdministrationORAL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1150 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other01/01/2016
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other01/01/2016
Labeler - California Pharmaceuticals LLC (021420944)
Registrant - California Pharmaceuticals LLC (021420944)
Establishment
NameAddressID/FEIBusiness Operations
California Pharmaceuticals LLC021420944manufacture(70332-103)

Revised: 1/2016
Document Id: 28c7a185-4081-1448-e054-00144ff8d46c
Set id: 271bfbb6-4996-500a-e054-00144ff8d46c
Version: 2
Effective Time: 20160107
 
California Pharmaceuticals LLC