Tussionex Pennkinetic (Page 4 of 4)

PRINCIPAL DISPLAY PANEL — 115 mL Bottle Label

NDC 53014-548-01
Rx ONLY

CII

Tussionex ®
Pennkinetic®
(hydrocodone polistirex and
chlorpheniramine polistirex)
Extended-Release Suspension

equivalent to 10 mg hydrocodone
bitartrate/8 mg chlorpheniramine
maleate per 5 mL

Nonalcoholic
12-hour Dosing

Contraindicated in
children under
6 years of age

Dispense enclosed
Medication Guide to
each patient.

Dispense entire carton as one unit

4 oz. (115 mL)

Principal Display Panel -- 115 mL Bottle Label
(click image for full-size original)
TUSSIONEX PENNKINETIC hydrocodone polistirex and chlorpheniramine polistirex suspension, extended release
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:53014-548
Route of Administration ORAL DEA Schedule CII
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
hydrocodone (hydrocodone) hydrocodone bitartrate 10 mg in 5 mL
chlorpheniramine (chlorpheniramine) chlorpheniramine maleate 8 mg in 5 mL
Inactive Ingredients
Ingredient Name Strength
ascorbic acid
D&C Yellow No. 10
ethylcellulose, unspecified
FD&C Yellow No. 6
high fructose corn syrup
methylparaben
polyethylene glycol 3350
polysorbate 80
starch, corn
propylene glycol
propylparaben
water
sucrose
xanthan gum
Product Characteristics
Color YELLOW (gold) Score
Shape Size
Flavor Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:53014-548-01 1 BOTTLE, PLASTIC in 1 CARTON contains a BOTTLE, PLASTIC
1 115 mL in 1 BOTTLE, PLASTIC This package is contained within the CARTON (53014-548-01)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA019111 12/31/1987
Labeler — Unither Manufacturing LLC (079176615)

Revised: 01/2017 Unither Manufacturing LLC

Page 4 of 4 1 2 3 4

All MedLibrary.org resources are included in as near-original form as possible, meaning that the information from the original provider has been rendered here with only typographical or stylistic modifications and not with any substantive alterations of content, meaning or intent.

This site is provided for educational and informational purposes only, in accordance with our Terms of Use, and is not intended as a substitute for the advice of a medical doctor, nurse, nurse practitioner or other qualified health professional.

Privacy Policy | Copyright © 2021. All Rights Reserved.