FDA label 9d58e774-94a9-4007-880d-003ef41dfc56

WARNINGS 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 central nervous system stimulation with convulsions or cardiovascular collapse with accompanying hypotension. Nervousness, dizziness or sleeplessness may occur at higher doses. Hypertensive crises can occur with concurrent use of pseudoephedrine and MAOI, indomethacin, or with beta blockers and methyldopa. If a hypertensive crisis occurs, these drugs should be discontinued immediately and therapy to lower blood pressure should be instituted. Fever should be managed by means of external cooling. Do not exceed recommended dosage .

WARNINGS: KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN. IN CASE OF ACCIDENTAL OVERDOSE, SEEK PROFESSIONAL ASSISTANCE OR CONTACT A POISON CONTROL CENTER IMMEDIATELY.

PRECAUTIONS General: Before prescribing medication to suppress or modify cough, it is important that the underlying cause of cough is identified, that modification of cough does not increase the risk of clinical or physiologic complications, and that appropriate therapy for the primary disease is instituted. Check with physician if cough persists after medication has been used for seven days or if high fever, skin rash, or continued headache, or sore throat is present with cough. Caution should be exercised in patients with high blood pressure, heart disease, diabetes mellitus, or thyroid disease. Dextromethorphan should be used with caution in sedated or debilitated patients, and in patients confined to the supine position. Administration of dextromethorphan may be accompanied by histamine release and should be used with caution in atopic children. The antihistamine in Atuss® DS Tannate Suspension may exhibit additive effects with CNS depressants, including alcohol. Phenylketonurics: Contains Phenylalanine 25.25 mg. per 5 mL. Information for Patients: Patient consultation should include the following information regarding proper use of Atuss® DS Tannate Suspension : Atuss® DS Tannate Suspension may be taken with food to minimize gastric irritation . Do not take MAOI while taking Atuss® DS Tannate Suspension . Keep all medications out of the reach of children. In case of accidental overdose, seek professional assistance or contact a poison control center immediately. Antihistamines may impair mental and physical abilities required for the performance of potentially hazardous tasks, such as driving a vehicle or operating machinery. Drug Interactions: MAOI and tricyclic antidepressants may prolong and intensify the anticholinergic (drying) effects of antihistamines. Beta-adrenergic blockers and MAOI may potentiate the pressor effect of pseudoephedrine. Concurrent use of digitalis glycosides may increase the possibility of cardiac arrhythmias. Sympathomimetics may reduce the hypotensive effects of guanethidine, mecamylamine, methyldopa, reserpine and veratrum alkaloids. Concurrent use of tricyclic antidepressants may antagonize the effects of pseudoephedrine. Concomitant use of antihistamines with alcohol, tricyclic antidepressants, barbiturates and other CNS depressants may have an additive effect. Laboratory Test Interactions: The in vitro addition of pseudoephedrine to sera containing the cardiac isoenzyme MB of serum creatine phosphokinase progressively inhibits the activity of the enzyme. The inhibition becomes complete over six hours . Carcinogenesis, Mutagenesis, Impairment of Fertility: No data is available on the long-term potential of the components of Atuss® DS Tannate Suspension for carcinogenesis, mutagenesis or impairment of fertility in animals or humans. Pregnancy: Category C: Animal reproduction studies have not been conducted with Atuss® DS Tannate Suspension . It is also not known if Atuss® DS Tannate Suspension can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Nursing Mothers: Pseudoephedrine is excreted in breast milk. Use of Atuss® DS Tannate Suspension by nursing mothers is not recommended because of the higher-than-usual risk for infants from sympathomimetic amines. Pediatric Use: Safety and effectiveness of Atuss® DS Tannate Suspension in pediatric patients under the age of two years have not been established. Pseudoephedrine may be more likely to cause side effects in infants, especially newborn and premature infants, than in older children and adults. No age specific problems related to dextromethorphan or chlorpheniramine have been documented in the pediatric population to date. Demonstrate safe use of a short-acting sympathomimetic amine before use of a sustained-action formulation in pediatric patients. Geriatric Use: (Ages 65 and older) Geriatric patients taking sympathomimetics may be more likely to experience confusion, hallucinations, seizures, and central nervous system depression. Geriatric patients may also be more sensitive to the effects, especially to the vasopressor effects, of sympathomimetic amines. Demonstrate safe use of a short-acting sympathomimetic formulation before use of a sustained-action formulation in elderly patients.

General: Before prescribing medication to suppress or modify cough, it is important that the underlying cause of cough is identified, that modification of cough does not increase the risk of clinical or physiologic complications, and that appropriate therapy for the primary disease is instituted. Check with physician if cough persists after medication has been used for seven days or if high fever, skin rash, or continued headache, or sore throat is present with cough. Caution should be exercised in patients with high blood pressure, heart disease, diabetes mellitus, or thyroid disease. Dextromethorphan should be used with caution in sedated or debilitated patients, and in patients confined to the supine position. Administration of dextromethorphan may be accompanied by histamine release and should be used with caution in atopic children. The antihistamine in Atuss® DS Tannate Suspension may exhibit additive effects with CNS depressants, including alcohol.

ADVERSE REACTIONS Pseudoephedrine may cause mild central nervous system 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. Adverse effects associated with dextromethorphan are generally infrequent and mild. Products containing dextromethorphan have been associated with nausea, dizziness, fatigue, gastrointestinal disturbances, and skin eruptions. 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.