FDA label 0c00a9f9-0de6-4d16-9f23-f114b71dc894

BOXED WARNING WARNING: RISKS FROM CONCOMITANT USE WITH BENZODIAZEPINES OR OTHER CNS DEPRESSANTS Concomitant use of opioids with benzodiazepine or other central nervous system (CNS) depressants, including alcohol, may result in profound sedation, respiratory depression, coma, and death (see WARNINGS and PRECAUTIONS – Drug Interactions ). Avoid use of opioid cough medications in patients taking benzodiazepines, other CNS depressants, or alcohol.

WARNINGS Contains sodium metabisulfite, a sulfite that may cause allergic-type reactions including anaphylactic symptoms and life-threatening or less severe asthmatic episodes in certain susceptible people. The overall prevalence of sulfite sensitivity in the general population is unknown and probably low. Sulfite sensitivity is seen more frequently in asthmatic than in nonasthmatic people. Risk from Concomitant Use with Benzodiazepines or other CNS Depressants Concomitant use of opioids, including Hydrocodone Polistirex and Chlorpheniramine Polistirex ER Suspension, with benzodiazepines, or other CNS depressants, including alcohol, may result in profound sedation, respiratory depression, coma, and death. Because of these risks, avoid use of opioid cough medications in patients taking benzodiazepines, other CNS depressants, or alcohol (see PRECAUTIONS – Drug Interactions ). Observational studies have demonstrated that concomitant use of opioid analgesics and benzodiazepines increases the risk of drug-related mortality compared to use of opioids alone. Because of similar pharmacologic properties, it is reasonable to expect similar risk with concomitant use of opioid cough medications and benzodiazepines, other CNS depressants, or alcohol. Advise both patients and caregivers about the risks of respiratory depression and sedation if Hydrocodone Polistirex and Chlorpheniramine Polistirex ER Suspension is used with benzodiazepines, alcohol, or other CNS depressants (see PRECAUTIONS – Information for Patients ). Respiratory Depression As with all narcotics, Hydrocodone Polistirex and Chlorpheniramine Polistirex ER Suspension produces dose-related respiratory depression by directly acting on brain stem respiratory centers. Hydrocodone affects the center that controls respiratory rhythm and may produce irregular and periodic breathing. Caution should be exercised when Hydrocodone Polistirex and Chlorpheniramine Polistirex ER Suspension is used postoperatively and in patients with pulmonary disease, or whenever ventilatory function is depressed. If respiratory depression occurs, it may be antagonized by the use of naloxone hydrochloride and other supportive measures when indicated (see OVERDOSAGE ). Head Injury and Increased Intracranial Pressure 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. Acute Abdominal Conditions The administration of narcotics may obscure the diagnosis or clinical course of patients with acute abdominal conditions. Obstructive Bowel Disease Chronic use of narcotics may result in obstructive bowel disease especially in patients with underlying intestinal motility disorder. Pediatric Use The use of Hydrocodone Polistirex and Chlorpheniramine Polistirex ER Suspension is contraindicated in children less than 6 years of age (see CONTRAINDICATIONS ). In pediatric patients, as well as adults, the respiratory center is sensitive to the depressant action of narcotic cough suppressants in a dose-dependent manner. Caution should be exercised when administering Hydrocodone Polistirex and Chlorpheniramine Polistirex ER Suspension to pediatric patients 6 years of age and older. Overdose or concomitant administration of Hydrocodone Polistirex and Chlorpheniramine Polistirex ER Suspension with other respiratory depressants may increase the risk of respiratory depression in pediatric patients. Benefit to risk ratio should be carefully considered, especially in pediatric patients with respiratory embarrassment (e.g., croup) (see PRECAUTIONS ).

ADVERSE REACTIONS Gastrointestinal Disorders Nausea and vomiting may occur; they are more frequent in ambulatory than in recumbent patients. Prolonged administration of Hydrocodone Polistirex and Chlorpheniramine Polistirex ER Suspension may produce constipation General Disorders and Administration Site Conditions Death Nervous System Disorders Sedation, drowsiness, mental clouding, lethargy, impairment of mental and physical performance, anxiety, fear, dysphoria, euphoria, dizziness, psychic dependence, mood changes. Renal and Urinary Disorders Ureteral spasm, spasm of vesical sphincters, and urinary retention have been reported with opiates. Respiratory, Thoracic and Mediastinal Disorders Dryness of the pharynx, occasional tightness of the chest, and respiratory depression (see CONTRAINDICATIONS ). Hydrocodone Polistirex and Chlorpheniramine Polistirex ER Suspension may produce dose-related respiratory depression by acting directly on brain stem respiratory centers (see OVERDOSAGE ). Use of Hydrocodone Polistirex and Chlorpheniramine Polistirex ER Suspension in children less than 6 years of age has been associated with fatal respiratory depression. Overdose with Hydrocodone Polistirex and Chlorpheniramine Polistirex ER Suspension in children 6 years of age and older, in adolescents, and in adults has been associated with fatal respiratory depression. Skin and Subcutaneous Tissue Disorders Rash, pruritus. To report SUSPECTED ADVERSE REACTIONS, contact Tris Pharma, Inc., at (732) 940-0358 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch