Label: DICOPANOL- diphenhydramine hydrochloride kit
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Contains inactivated NDC Code(s)
NDC Code(s): 70332-103-01 - Packager: California Pharmaceuticals LLC
- Category: HUMAN PRESCRIPTION DRUG LABEL
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.
Drug Label Information
Updated January 7, 2016
If you are a healthcare professional or from the pharmaceutical industry please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Dicopanol, Instructions for Use, Page 2
- Instructions for Preparation - page 1
- Diphenhydramine - label
- Dicopanol. Package Label
- Dicopanol - Flavor Suspension label
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INGREDIENTS AND APPEARANCE
DICOPANOL
diphenhydramine hydrochloride kitProduct 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 suspensionProduct 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 liquidProduct 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)
