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™ extended-release capsules 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.
|
