FDA label 7c270448-5295-4568-b00b-019435e60a3e

WARNINGS Do not exceed recommended dosage. May cause excitability especially in children. Do not take this product, unless directed by a doctor, if you have a breathing problem such as emphysema or chronic bronchitis, or if you have glaucoma or difficulty in urination due to enlargement of the prostate gland. 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 give this product to children under 12 years of age, or children who are taking sedatives, or tranquilizers, without first consulting the child's 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 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. Adults and children who have a chronic pulmonary disease or shortness of breath, or children (over 12 years of age) who are taking other drugs, should not take this product unless directed by a doctor. May cause or aggravate constipation. Use caution when giving to children (see PRECAUTIONS, Pediatric Use ), or patients with chronic pulmonary disease, shortness of breath, difficulty in breathing, asthma, emphysema, high blood pressure, heart disease, diabetes, thyroid disease, or difficulty in urination due to the enlargement of the prostate gland unless directed by a physician. Antihistamines may cause hyperexcitability, especially in children. At doses higher than the recommended dose, nervousness, dizziness, or sleeplessness may occur. Especially in infants and small children, antihistamines in overdosage may cause hallucinations, convulsions, and death. If a hypertensive crisis occurs, these drugs should be discontinued immediately and therapy to lower blood pressure should be instituted immediately. Fever should be managed by means of external cooling. Do not take this product if you are pregnant or nursing.

ADVERSE REACTIONS The most frequent adverse reactions to this product include: sedation, dryness of mouth, nose and throat, thickening of bronchial secretions, and dizziness. Other adverse reactions may include: Cardiovascular System: Hypotension, headache, palpitations, tachycardia, extra systoles. Dermatologic: Urticaria, drug rash, photosensitivity, and pruritus. Central Nervous System: Sedation, sleepiness, dizziness, disturbed coordination, fatigue, confusion, restlessness, excitation, nervousness, tremor, irritability, insomnia, euphoria, paresthesias, blurred vision, diplopia, vertigo, tinnitus, acute labyrinthitis, hysteria, neuritis, convulsions. 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 and wheezing, nasal stuffiness. Hematologic System: Hemolytic anemia, thrombocytopenia, agranulocytosis.