FDA label 37c43340-e826-4946-81f1-494fae51e91e

WARNINGS Respiratory Depression – As with all narcotics, TussiCaps ® extended-release capsules produce 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 TussiCaps ® extended-release capsules are 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 TussiCaps ® extended-release capsules are 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 TussiCaps ® extended-release capsules to pediatric patients 6 years of age and older. Overdose or concomitant administration of TussiCaps ® extended-release capsules 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 TussiCaps ® extended-release capsules 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 ). TussiCaps ® extended-release capsules may produce dose-related respiratory depression by acting directly on brain stem respiratory centers ( see OVERDOSAGE ). Use of TussiCaps ® in children less than 6 years of age has been associated with fatal respiratory depression. Overdose with TussiCaps ® extended-release capsules 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 Valeant Pharmaceuticals, North America LLC at 1-800-321-4576 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.