how tussionex® works
to suppress cough

Trust in TUSSIONEX®: For relief of cough and upper respiratory symptoms due to allergy or upper respiratory infections in adults and children ≥6 years of age for over 20 years

TUSSIONEX® quiets the cough center with hydrocodone, a centrally acting narcotic antitussive.

TUSSIONEX® is a hydrocodone-based syrup containing chlorpheniramine, a first-generation antihistamine.

  • First-generation antihistamines suppress cough due to upper respiratory infection by acting on histaminergic and/or M1 muscarinic receptors in the respiratory mucosa.

TUSSIONEX® may help provide restful sleep

  • May reduce sleep interruptions, which may occur with the need to re-dose short-acting antitussives

Up to 12 Hours With 1 Dose

IMPORTANT SAFETY INFORMATION

  • TUSSIONEX® is contraindicated in children less than 6 years of age due to the risk of fatal depression, and in patients with a known allergy or sensitivity to hydrocodone or chlorpheniramine.
  • TUSSIONEX® may produce dose-related respiratory depression or irregular and periodic breathing. Caution should be exercised when TUSSIONEX is used postoperatively and in patients with pulmonary disease, or whenever ventilatory function is depressed.
  • The respiratory depressant effects of narcotics and their capacity to elevate cerebrospinal fluid pressure may be markedly exaggerated in the presence of head injury, other intracranial lesions, or a pre-existing increase in intracranial pressure. Furthermore, narcotics produce adverse reactions, which may obscure the clinical course of patients with head injuries.
  • TUSSIONEX® is a Schedule III narcotic. Psychic dependence, physical dependence and tolerance may develop upon repeated administration of narcotics; therefore, TUSSIONEX Pennkinetic Extended-Release Suspension should be prescribed and administered with caution.
  • The administration of narcotics may obscure the diagnosis or clinical course of patients with acute abdominal conditions.
  • Chronic use of narcotics may result in obstructive bowel disease especially in patients with underlying intestinal motility disorder.
  • Caution is advised when prescribing this drug to patients with narrow-angle glaucoma, asthma, or prostatic hypertrophy.
  • TUSSIONEX® should be used with caution in elderly or debilitated patients and those with severe impairment of hepatic or renal function, hypothyroidism, Addison's disease, prostatic hypertrophy, or urethral stricture.
  • Hydrocodone suppresses the cough reflex; caution should be exercised when TUSSIONEX® is used postoperatively, and in patients with pulmonary disease.
Indication

TUSSIONEX® is indicated for relief of cough and upper respiratory symptoms associated with allergy or a cold in adults and children 6 years of age and older.

You are encouraged to report negative side effects of prescription drugs to the FDA.
Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.

References:
1. US Food and Drug Administration. Approval History NDA 019111. Drugs@FDA.
http://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm?fuseaction=Search.DrugDetails. Accessed September 12, 2011.

2. IMS Health, Inc. National Prescription Audit, 2010.

TUSSIONEX®, PENNKINETIC®, and COUGH RELIEVED. REST ASSURED.™ are trademarks of the UCB Group of companies. All other trademarks are owned by their respective trademark holders.