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

PRINCIPAL DISPLAY PANEL

4 oz. label
(click image for full-size original)

4 fl. oz. (115 mL) Label

PRINCIPAL DISPLAY PANEL

4 oz. carton
(click image for full-size original)

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
(click image for full-size original)

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)

70mL Label
(click image for full-size original)

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)

70mL Carton
(click image for full-size original)
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

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