FDA label a2cc347d-1da7-44ad-8fe5-7935cc3b3737

WARNINGS Antihistamines may cause drowsiness, dizziness, blurred vision, and otherwise impair mental and physical abilities required for the performance of potentially hazardous tasks, such as driving a vehicle or operating machinery. Sympathomimetic amines should be used cautiously, extremely carefully and sparingly in patients with hypertension, diabetes mellitus, ischemic heart disease, increased intraocular pressure, narrow-angle glaucoma, stenosing peptic ulcer, pyloroduodenal obstruction, symptomatic prostatic hypertrophy, bladder-neck obstruction, hyperthyroidism or prostatic hypertrophy. Sympathomimetics may produce central nervous system stimulation with convulsions or cardiovascular collapse with accompanying hypotension. Products which contain diphenhydramine should not be used in combination with other diphenhydramine formulations; in rare cases toxic psychosis has occurred in children who received combinations of two or more diphenhydramine formulations by any route of administration including topically applied preparations. Respiratory Depression At high doses or in sensitive patients, codeine may produce dose-related respiratory depression by acting directly on the brain stem respiratory center. Codeine 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 a 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. Infants and Children Diphenhydramine should not be administered to premature or full-term neonates. Infants may have greater susceptibility than adults to the toxic effects of diphenhydramine. Adults who administer diphenhydramine to children should be aware that children may be at increased risk for excitability and central nervous system stimulation. Antihistamine may impair mental alertness in children.

ADVERSE REACTIONS Antitussives: may include drowsiness, dizziness, nausea or vomiting, constipation, dry mouth, headache, nervousness or restlessness, feeling of well-being, confusion, urinary disturbances, increased sweating, skin rash, hives, itching, swelling of face, flushing, weakness, visual disturbances, change in heart rate, difficulty breathing, loss of appetite, or general feeling of illness or discomfort. Possible allergic reaction to material if inhaled, ingested, or contacts with skin. Sympathomimetic Amines: Hyperactive individuals 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. Antihistamines: 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. Other adverse reactions include Central Nervous System: Drowsiness, metal clouding, lethargy, impairment of mental and physical performance, anxiety, fear, dysphoria, psychic dependence, mood changes. Gastrointestinal System : The antiemetic phenothiazines are useful in suppressing the nausea and vomiting which may occur (see above); however, some phenothiazine derivatives seem to be antianalgesic and 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 spasms, spasm of vesical sphincters and urinary retention have been reported. Respiratory Depression: Codeine may produce dose-related respiratory depression by acting directly on the brain stem respiratory center. Codeine also affects the center that controls respiratory rhythm, and may produce irregular and periodic breathing. If significant respiratory depression occurs, it may be antagonized by the use of naloxone hydrochloride. Apply other supportive measures when indicated.