Hydrocodone Polistirex and Chlorpheniramine Polistirex (Page 4 of 4)

HYDROCODONE POLISTIREX AND CHLORPHENIRAMINE POLISTIREX SUSPENSION, EXTENDED RELEASE

Label ImageLabel Image
HYDROCODONE POLISTIREX AND CHLORPHENIRAMINE POLISTIREX
hydrocodone polistirex and chlorpheniramine polistirex suspension, extended release
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:17856-0301(NDC:62542-301)
Route of Administration ORAL DEA Schedule CII
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
HYDROCODONE (HYDROCODONE) HYDROCODONE 10 mg in 5 mL
CHLORPHENIRAMINE (CHLORPHENIRAMINE) CHLORPHENIRAMINE 8 mg in 5 mL
Inactive Ingredients
Ingredient Name Strength
Water
High Fructose Corn Syrup
Sucrose
Propylene Glycol
Xanthan Gum
Corn Oil
Methylparaben
Polysorbate 80
Ascorbic Acid
Propylparaben
ETHYLCELLULOSE, UNSPECIFIED
Sorbitol
Dibutyl Sebacate
D&C Yellow No. 10
FD&C Yellow No. 6
Sodium Benzoate
Phosphoric Acid
Product Characteristics
Color YELLOW (gold) Score
Shape Size
Flavor MANGO Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:17856-0301-1 72 CUP in 1 CASE contains a CUP
1 5 mL in 1 CUP This package is contained within the CASE (17856-0301-1)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA091671 10/23/2014
Labeler — Atlantic Biologicals Corps (047437707)
Establishment
Name Address ID/FEI Operations
Atlantic Biologicals Corps 047437707 RELABEL (17856-0301), REPACK (17856-0301)

Revised: 06/2017 Atlantic Biologicals Corps

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