warnings
WARNINGS Do not exceed recommended dosage. If nervousness, dizziness, or sleeplessness occur, discontinue use and consult a doctor. When using this product, TL-HIST CD Liquid may cause marked drowsiness. A persistent cough may be a sign of a serious condition. If cough persists for more than 1 week, tends to recur, or is accompanied by a fever, rash, or persistent headache, consult a doctor. Do not take this product for persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema, or where cough is accompanied by excessive phlegm (mucus) unless directed by a physician. Antihistamines should be used with caution in patients with narrow angle glaucoma, stenosing peptic ulcer, pyloroduodenal obstruction, symptomatic prostatic hypertrophy, and urinary bladder neck obstruction. Antihistamines and/or decongestants may cause excitability, particularly in children. At doses higher than the recommended dose, nervousness, dizziness, or sleeplessness may occur. Patients sixty (60) years and older may demonstrate an increased response to this drug combination, both in therapeutic effect and in the incidence of adverse reactions and hence a lower dose may be more appropriate for these patients. Sympathomimetic amines should be used judiciously and sparingly in patients with hypertension, diabetes mellitus, ischemic heart disease, increased intraocular pressure, hyperthyroidism, or prostatic hypertrophy. Sympathomimetics may produce CNS stimulation and convulsions or cardiovascular collapse with accompanying hypotension. Hypertensive crises can occur with concurrent use of Phenylephrine and MAO inhibitor, and for 14 days after stopping MAO inhibitor therapy, indomethacin, or with beta blockers and methyldopa. If a hypertensive crisis occurs, these drugs should be discontinued immediately and therapy in lower blood pressure should be instituted. Fever should be managed by means of external cooling. Dosage of codeine SHOULD NOT BE INCREASED if cough fails to respond; an unresponsive cough should be reevaluated in 5 days or sooner for possible underlying pathology, such as foreign body or lower respiratory tract disease. Codeine may cause or aggravate constipation. Respiratory depression leading to arrest, coma, and death has occurred with the use of codeine antitussive in young children, particularly in the under-one-year infants whose ability to deactivate the drug is not fully developed. Administration of codeine may be accomplished by histamine release and should be used with caution in atopic children. Head Injury and Increased Intracranial Pressure The respiratory depressant effects of narcotic analgesics and their capacity to elevate cerebrospinal fluid pressure may be markedly exaggerated in the presence of head injury, intracranial lesions, or a reexisting increase in intracranial pressure. Narcotics may produce adverse reactions which may obscure the clinical course of patients with head injuries. Asthma and Other Respiratory Conditions Narcotic analgesics or cough suppressants, including codeine, should not be used in asthmatic patients. Nor should they be used in acute febrile illness associated with productive cough or in chronic respiratory disease where interference with ability to clear the tracheobronchial tree of secretions would have a deleterious effect on the patient's respiratory function. Hypotensive Effect Codeine may produce orthostatic hypotension in ambulatory patients.