Hydrocodone Polistirex and Chlorpheniramine Polistirex Extended-release (Page 11 of 11)

PRINCIPAL DISPLAY PANEL

4 fl. oz. (115 mL) Label

PRINCIPAL DISPLAY PANEL

4 oz. carton

PRINCIPAL DISPLAY PANEL

NDC 27808-086-02

Hydrocodone Polistirex and Chlorpheniramine Polistirex Extended-Release Suspension CII

PHARMACIST: Dispense the accompanying Medication Guide to each patient.

Rx only

16 fl. oz. (473 mL)

16 oz label

PRINCIPAL DISPLAY PANEL

NDC 27808-086-03

Hydrocodone Polistirex and Chlorpheniramine Polistirex Extended-Release Suspension CII

PHARMACIST: Dispense the accompanying Medication Guide to each patient.

Rx only

(70 mL)

PRINCIPAL DISPLAY PANEL

NDC 27808-086-03

Hydrocodone Polistirex and Chlorpheniramine Polistirex Extended-Release Suspension CII

PHARMACIST: Dispense the accompanying Medication Guide to each patient.

Rx only

(70 mL)

HYDROCODONE POLISTIREX AND CHLORPHENIRAMINE POLISTIREX EXTENDED-RELEASE hydrocodone polistirex and chlorpheniramine polistirex suspension, extended release

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:27808-086 Route of Administration ORAL DEA Schedule CII

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength HYDROCODONE BITARTRATE (HYDROCODONE) HYDROCODONE BITARTRATE 10 mg in 5 mL CHLORPHENIRAMINE MALEATE (CHLORPHENIRAMINE) CHLORPHENIRAMINE MALEATE 8 mg in 5 mL

Inactive Ingredients Ingredient Name Strength ASCORBIC ACID D&C YELLOW NO. 10 HIGH FRUCTOSE CORN SYRUP METHYLPARABEN POLYSORBATE 80 POLYVINYL ACETATE PROPYLENE GLYCOL PROPYLPARABEN WATER SODIUM ASCORBATE SODIUM METABISULFITE SODIUM POLYSTYRENE SULFONATE SUCROSE TRIACETIN XANTHAN GUM STARCH, CORN

Product Characteristics Color yellow Score Shape Size Flavor PEACH, PINEAPPLE Imprint Code Contains

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:27808-086-02 473 mL in 1 BOTTLE None 2 NDC:27808-086-01 1 BOTTLE, UNIT-DOSE in 1 CARTON contains a BOTTLE, UNIT-DOSE 2 115 mL in 1 BOTTLE, UNIT-DOSE This package is contained within the CARTON (27808-086-01) 3 NDC:27808-086-03 1 BOTTLE, UNIT-DOSE in 1 CARTON contains a BOTTLE, UNIT-DOSE 3 70 mL in 1 BOTTLE, UNIT-DOSE This package is contained within the CARTON (27808-086-03)

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA091632 03/06/2015

Labeler — Tris Pharma Inc (947472119)

Revised: 05/2021 Tris Pharma Inc