FDA label 31c791f4-c040-46a3-8326-3f6f0eeb1f95

WARNINGS Do not exceed recommended dosage. If nervousness, dizziness, or sleeplessness occurs, discontinue use and consult a doctor. If symptoms do not improve within 7 days or are accompanied by a fever, consult a doctor. May cause drowsiness; alcohol, sedatives, and tranquilizers may increase the drowsiness effect. Avoid alcoholic beverages while taking this product. Do not take this product if you are taking sedatives or tranquilizers, without first consulting your doctor. Use caution when driving a motor vehicle or operating machinery. Do not take this product for persistent or chronic cough such as occurs with smoking, asthma, or emphysema, or if cough is accompanied by excessive phlegm (mucus) unless directed by a doctor. 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 fever, rash, or persistent headache, consult a doctor. Do not take this product if you have a chronic pulmonary disease or shortness of breath unless directed by your doctor. Dihydrocodeine should be prescribed and administered with the same degree of caution as all oral medications containing a narcotic analgesic. Patients should be warned that dihydrocodeine bitartrate is potentially habit forming. Extreme caution should be exercised in the use of dihydrocodeine in patients with severe respiratory impairment or patients with impaired respiratory drive. If pregnant, or planning to become pregnant or are currently breast-feeding please contact your physician, or health-care provider before using or continuing use. Use in Elderly The elderly (60 years and older) are more likely to have adverse reactions to sympathomimetics. Overdosage of sympathomimetics in this age group may cause hallucinations, convulsions, CNS depression and death. Respiratory Depression At high doses or in sensitive patients. Dihydrocodeine may produce dose-related respiratory depression by acting directly on the brain stem respiratory center. Dihydrocodeine also affects the center that controls respiratory rhythm, and may produce irregular and periodic breathing. 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 preexisting 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. 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 central nervous system stimulation with convulsions or cardiovascular collapse with accompanying hypotension. Antihistamines may impair mental and physical abilities required for the performance of potentially hazardous tasks, such as driving a vehicle or operating machinery, and may impair mental alertness in children. Chlorpheniramine has an atropine-like action and should be used with caution in patients with increased intraocular pressure, increased intraocular pressure, cardiovascular disease, hypertension, or in patients with a history of bronchial asthma. Do not exceed recommended dosage.

ADVERSE REACTIONS The most frequently observed reactions with dihydrocodeine include lightheadedness, dizziness, drowsiness, sedation, nausea and vomiting. These effects seem to be more prominent in ambulatory than in nonambulatory patients and some of these adverse reactions may be alleviated if the patient lies down. Patients sensitive to antihistamines may experience mild sedation. Possible side effects, of antihistamines are drowsiness, restlessness, dizziness, weakness, dry mouth, anorexia, nausea, vomiting, headache, nervousness, blurring of vision, polyuria, heartburn, dysuria and, very rarely, dermatitis. Individuals hyperreactive to sympathomimetic amines may display ephedrine-like reactions such as tachycardia, palpitations, headache, dizziness, or nausea. Sympathomimetics have been associated with certain untoward reactions including restlessness, tremor, weakness, pallor, respiratory difficulty, dysuria, insomnia, hallucinations, convulsions, CNS depression, arrhythmias and cardiovascular collapse with hypotension. Other adverse reactions include: Central Nervous System: Drowsiness, mental clouding, lethargy, impairment of mental and physical performance, anxiety, fear, dysphoria, psychic dependence, mood changes. Gastrointestinal System: The antiemetic phenothiazines are useful suppressing the nausea and vomiting which may occur, however, some phenothiazine derivatives seem to be anti analgesic and tend to increase the amount of narcotic required to produce pain relief, while other phenothiazines reduce the amount of narcotic required to produce a given level of analgesia. Genitourinary System: Ureteral spasm, spasm of vesical sphincters and urinary retention have been reported. Respiratory Depression: If significant respiratory depression occurs, it may be antagonized by the use of naloxone hydrochloride. Apply other supportive measures when indicated.