FDA label c593d9c8-a448-4439-8a9f-613714ddf6f3

WARNINGS Respiratory Depression: At high doses or in sensitive patients, hydrocodone may produce dose-related respiratory depression by acting directly on the brain stem respiratory center. Hydrocodone 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. 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 doctor. Sympathomimetic amines should be used with caution in patients with hypertension, ischemic heart disease, diabetes mellitus, increased intraocular pressure, hyperthyroidism, or prostatic hypertrophy. Sympathomimetics may produce CNS stimulation with convulsions or cardiovascular collapse with accompanying hypotension. Nervousness, dizziness or sleeplessness may occur at higher doses. Do not exceed recommended dosage.

Respiratory Depression: At high doses or in sensitive patients, hydrocodone may produce dose-related respiratory depression by acting directly on the brain stem respiratory center. Hydrocodone 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. 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 doctor. Sympathomimetic amines should be used with caution in patients with hypertension, ischemic heart disease, diabetes mellitus, increased intraocular pressure, hyperthyroidism, or prostatic hypertrophy. Sympathomimetics may produce CNS stimulation with convulsions or cardiovascular collapse with accompanying hypotension. Nervousness, dizziness or sleeplessness may occur at higher doses. Do not exceed recommended dosage.

ADVERSE REACTIONS The most frequent side effects observed with hydrocodone include lightheadedness, dizziness, drowsiness, sedation, nausea, and vomiting. These effects seem to be more prominent in ambulatory than in non-ambulatory patients and some of these adverse reactions may be alleviated if the patient lies down. Pseudoephedrine may cause mild CNS stimulation, especially in those patients who are hypersensitive to sympathomimetic drugs. Nervousness, excitability, restlessness, dizziness, weakness and insomnia may also occur. Headache and drowsiness have also been reported. Large doses may cause lightheadedness, nausea and/or vomiting. Sympathomimetics have been associated with certain untoward reactions including fear, anxiety, nervousness, restlessness, tremor, weakness, pallor, respiratory difficulty, dysuria, insomnia, hallucinations, convulsions, CNS depression, arrhythmias, and cardiovascular collapse with hypotension. Chlorpheniramine may cause slight to moderate drowsiness and is the most frequent side effect. Other possible side effects of antihistamines include: General : Urticaria, drug rash, anaphylactic shock, photosensitivity, excessive perspiration, chills, dryness of mouth, nose and throat; Cardiovascular : Hypotension, headache, palpitation, tachycardia, extra systoles; Hematological : Hemolytic anemia, thrombocytopenia, agranulocytosis; CNS : Sedation, dizziness, disturbed coordination, fatigue, confusion, restlessness, excitation, nervousness, tremor, irritability, insomnia, euphoria, paresthesia, blurred vision, diplopia, vertigo, tinnitus, hysteria, neuritis, convulsion; Gastrointestinal : Epigastric distress, anorexia, nausea, vomiting, diarrhea, constipation; Genitourinary : Urinary frequency, difficult urination, urinary retention, early menses; Respiratory : Thickening of bronchial secretions, tightness of chest, wheezing and nasal stuffiness.