{"abuse":["Abuse"],"adverse_reactions":["ADVERSE REACTIONS Hyperreactive individuals may display ephedrine-like reactions such as tachycardia, palpitations, headache, dizziness or nausea. 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, No serious side effects have been reported with the use of guaifenesin."],"carcinogenesis_and_mutagenesis_and_impairment_of_fertility":["Carcinogenesis, Mutagenesis, Impairment of Fertility No data are available on the long term potential of the components of this product for carcinogenesis, mutagenesis, or impairment of fertility in animals or humans."],"clinical_pharmacology":["CLINICAL PHARMACOLOGY Guaifenesin is an expectorant which increases respiratory tract fluid secretions and helps to loosen phlegm and bronchial secretions. By reducing the viscosity of secretions, guaifenesin increases the efficiency of the cough reflex and of ciliary action in removing accumulated secretions from the trachea and bronchi. Guaifenesin is readily absorbed from the gastrointestinal tract and is rapidly metabolized and excreted in the urine. Guaifenesin has a plasma half-life of one hour. The major urinary metabolite is ß (2-methoxyphenoxy) lactic acid. Pseudoephedrine. a sympathomimetic amine, acts on alpha-adrenergic receptors in the mucosa of the respiratory tract, producing vasoconstriction. The medication shrinks swollen nasal mucous membranes, reduces tissue hyperemia. edema. and nasal congestion, and increases nasal airway patency. Also, drainage of sinus secretions is increased and obstructed eustachian ostia may be opened. Dextromethorphan HBr is an antitussive agent which unlike the isomeric levorphanol has no analgesic or addictive properties. The drug acts centrally and elevates the threshold for coughing. In therapeutic dosage. dextromethorphan is rapidly absorbed from the gastrointestinal tract, metabolized by the liver and excreted primarily in the urine."],"contraindications":["CONTRAINDICATIONS PROTUSS ® -DM is contraindicated in patients with hypersensitivity to any of its components or idiosyncrasy to sympathomimetic amines which may be manifested by insomnia, dizziness, weakness, tremor or arrhythmias."],"controlled_substance":["Controlled Substance"],"dependence":["Dependence"],"description":["DESCRIPTION Each PROTUSS ® -DM tablet contains: Guaifenesin..................................... 600 mg Pseudoephedrine HCI ..................... 60 mg Dextromethorphan HBr ................. 30 mg Guaifenesin is an expectorant. Chemically, it is 1,2 Propanediol, 3-(2-methoxyphenoxy) Pseudoephedrine Hydrochloride is a nasal decongestant having the chemical name: Benzenemethanol, α-[1-(methylamino)ethyl]-, (S-R*,R*)]-, hydrochloride. Dextromethorphan Hydrobromide is an antitussive agent having the chemical name: Morphinan, 3-methoxy-17-methyl-, (9α. 13α, 14α)-, hydrobromide, monohydrate."],"dosage_and_administration":["DOSAGE AND ADMINISTRATION Adults and children over 12 years of age: One or two tablets every 12 hours, not to exceed 4 tablets in 24 hours. Children 6 to 12 years; One tablet every 12 hours, not to exceed 2 tablets in 24 hours. Children 2 to 6 years: 1/2 tablet every 12 hours, not to exceed one tablet in. 24 hours. Not recommended for children underr 2 years of age."],"drug_abuse_and_dependence":["DRUG ABUSE AND DEPENDENCE Controlled Substance Abuse Dependence"],"drug_and_or_laboratory_test_interactions":["Drug/Laboratory Test Interactions"],"drug_interactions":["Interactions Drug Interactions Beta-adrenergic blockers and MAO inhibitors may potentiate the pressor effect of sympathomimetic amines. Concurrent use of digitalis gylcosides may increase the possibility of cardiac arrhythmias. Sympathomimetics may reduce the hypotensive effects of guanethidine, mecamylamine, methyldopa, reserpine and veratrum alkaloids. Drug/Laboratory Test Interactions","Drug Interactions Beta-adrenergic blockers and MAO inhibitors may potentiate the pressor effect of sympathomimetic amines. Concurrent use of digitalis gylcosides may increase the possibility of cardiac arrhythmias. Sympathomimetics may reduce the hypotensive effects of guanethidine, mecamylamine, methyldopa, reserpine and veratrum alkaloids."],"effective_time":"20110308","general_precautions":["General"],"geriatric_use":["Geriatric Use The elderly (60 years and older) are more likely to experience adverse reactions to sympathomimetics. Overdosage f sympathomimetics in this age group may cause hallucinations, convulsions, CNS depression and death."],"how_supplied":["HOW SUPPLIED PROTUSS ® -DM is a dye-free, sustained release tablet with PRO-DM on one side and scored on the other. Bottles of 100 tablets. NDC 59630-160-10. Bottles of 14 tablets. NDC 59630-160-14. Store at controlled room temperature, between 15 o -30 o C (59 o -86 o F). Dispense in tight containers with child resistant closures."],"id":"ece68688-1a72-4839-84fd-8cffe78500f9","indications_and_usage":["INDICATIONS AND USAGE PROTUSS ® -DM is indicated for the temporary relief of nasal congestion and cough associated with respiratory tract infections and related conditions such as sinusitis, pharyngitis, bronchitis, and asthma, particularly when these conditions are complicated with tenacious mucus and/or mucus plugs and congestion. PROTUSS ® DM is effective in productive as well as non-productive cough, but is of particular value in dry non-productive cough which tends to injure. the mucous membrane of the air passages."],"information_for_patients":["Information for Patients"],"labor_and_delivery":["Labor and Delivery"],"laboratory_tests":["Laboratory Tests"],"nonteratogenic_effects":["Nonteratogenic Effects"],"nursing_mothers":["Nursing Mothers Use of this product bynursing mothers is not recommended because of the higher than usual risk to infants from sympathomimetic amines."],"openfda":{},"overdosage":["OVERDOSAGE Overdosage with guaifenesin is unlikely to produce toxic effects since its toxicity is low. Guaifenesin, when administered by stomach tube to test animals in doses up to 5 grams/kg, produced no signs of toxicity. In severe cases of overdosage, treatment should be aimed at reducing further absorption of the drug. Gastric emptying (Syrup of Ipecac) and/or lavage is recommended as soon as possible after ingestion. Overdosage with dextromethorphan may produce central excitement and mental confusion. Very high doses may produce respiratory depression. One case of toxic psychosis (hyperactivity, marked visual and auditory hallucinations) after ingestion of a single 300 mg dose of dextromethorphan has been reported. Toxicity with pseudoephedrine may be manifest as excessive CNS stimulation resulting in excitement, tremor, restlessness, and insomnia. Other effects may include tachycardia, hypertension, pallor. mydriasis, hyperglycemia and urinary retention. Severe overdosage may cause tachypnea or hyperpnea, hallucinations, convulsions or delirium, but in some individuals there may be CNS depression with somnolence, stupor or respiratory depression. Arrhythmias (including ventricular fibrillation) may lead to hypotension and circulatory collapse. Adrenergic receptor blocking agents are antidotes to pseudoephedrine. In practice, the most useful is the beta-blocker propanolol which is indicated when there are signs of cardiac toxicity. Theoretically, pseudoephedrine is dialyzable but procedures have not been clinically established. In severe cases of overdosage, It is essential to monitor both the heart (by electrocardiograph) and plasma electrolytes, and to give intravenous potassium as indicated. Vasopressors may be used to treat hypotension. Excessive CNS stimulation may be counteracted with parenteral diazepam. Stimulants should not be. used."],"package_label_principal_display_panel":["PACKAGE/LABEL PRINCIPAL DISPLAY PANEL CONTAINER LABEL 6370 CL"],"pediatric_use":["Pediatric Use This product is not recommended for use in children under 2 years of age."],"precautions":["PRECAUTIONS Use with caution in patients with diabetes, hypertension, cardiovascular disease. Before prescribing medication to suppress or modify-cough, it is important to ascertain that the underlying cause of cough is identified, that modification of cough does not increase the risk of clinical or physiological complications, and that appropriate therapy for the primary disease is instituted. General Information for Patients Laboratory Tests Interactions Drug Interactions Beta-adrenergic blockers and MAO inhibitors may potentiate the pressor effect of sympathomimetic amines. Concurrent use of digitalis gylcosides may increase the possibility of cardiac arrhythmias. Sympathomimetics may reduce the hypotensive effects of guanethidine, mecamylamine, methyldopa, reserpine and veratrum alkaloids. Drug/Laboratory Test Interactions Carcinogenesis, Mutagenesis, Impairment of Fertility No data are available on the long term potential of the components of this product for carcinogenesis, mutagenesis, or impairment of fertility in animals or humans. Pregnancy CATEGORY C: Animal reproduction studies have not been conducted with the components of this product. It is also not known whether these drugs can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Therefore, this product should be given to a pregnant woman only if clearly needed Teratogenic Effects Nonteratogenic Effects Labor and Delivery Nursing Mothers Use of this product bynursing mothers is not recommended because of the higher than usual risk to infants from sympathomimetic amines. Pediatric Use This product is not recommended for use in children under 2 years of age. Geriatric Use The elderly (60 years and older) are more likely to experience adverse reactions to sympathomimetics. Overdosage f sympathomimetics in this age group may cause hallucinations, convulsions, CNS depression and death."],"pregnancy":["Pregnancy CATEGORY C: Animal reproduction studies have not been conducted with the components of this product. It is also not known whether these drugs can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Therefore, this product should be given to a pregnant woman only if clearly needed Teratogenic Effects Nonteratogenic Effects"],"set_id":"ece68688-1a72-4839-84fd-8cffe78500f9","spl_product_data_elements":["PROTUSS DEXTROMETHORPHAN, PSEUDOEPHEDRINE, and GUAIFENESIN DEXTROMETHORPHAN DEXTROMETHORPHAN PSEUDOEPHEDRINE HYDROCHLORIDE PSEUDOEPHEDRINE GUAIFENESIN GUAIFENESIN HYPROMELLOSE 2910 (15000 MPA.S) HYPROMELLOSE 2910 (5 MPA.S) ANHYDROUS DIBASIC CALCIUM PHOSPHATE SILICON DIOXIDE STEARIC ACID MAGNESIUM STEARATE PRO;DM"],"teratogenic_effects":["Teratogenic Effects"],"version":"1","warnings":["WARNINGS"]}