{"abuse":["Abuse"],"adverse_reactions":["ADVERSE REACTIONS No serious side effects from guaifenesin or dextromethorphan have been reported."],"carcinogenesis_and_mutagenesis_and_impairment_of_fertility":["Carcinogenesis, Mutagenesis, Impairment of Fertility No data are available on the long-term potential for carcinogenesis, mutagenesis, or impairment of fertility in animals or humans."],"clinical_pharmacology":["CLINICAL PHARMACOLOGY Guaifenesin is an expectorant which increases respiratory tract fluid secretion 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 readily metabolized and excreted in the urine. Guaifenesin has a plasma half-life of one hour. The major urinary metabolite is [3-(2-methoxyphenoxy) lactic acid Dextromethorphan 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. It is about equal to codeine in depressing the cough reflex. In therapeutic dosage, dextromethorphan does not inhibit ciliary activity. Dextromethorphan is rapidly absorbed from the gastrointestinal tract, metabolized by the liver and excreted primarily in the urine"],"contraindications":["CONTRAINDICATIONS The drug is contraindicated in patients with hypersensitivity to guaifenesin or dextromethorphan. This drug should not be used in patients receiving monoamine oxidase inhibitor therapy (MAOI) and for 14 days after stopping MAOI therapy."],"controlled_substance":["Controlled Substance"],"dependence":["Dependence"],"description":["DESCRIPTION Each dye-free, scored, long-acting tablet for oral administration contains: Guaifenesin ........................................................ 1000 mg Dextromethorphan HBr ...................................... 60 mg In a special base to provide a prolonged therapeutic effect. This product contains ingredients of the following therapeutic classes: antitussive and expectorant. It also contains dicalcium phosphate, hydroxypropyl methylcellulose, stearic acid, magnesium stearate, silicon dioxide and triacetin Guaifenesin is an expectorant having the chemical name 3-(2-methoxyphenoxy)-1 ,2-Propanediol. Oextromethorphan hydrobromide is an antitussive having the chemical name, 3-methoxy-17-methyl-9a, 13a, 14a-morphinan hydrobromide monohydrate."],"dosage_and_administration":["DOSAGE AND ADMINISTRATION Adults and children over 12 years of age: One tablet per 12 hours, not to exceed 2 tablets in 24 hours. Children 6 to 12 years of age: 12 tablet per 12 hours, not to exceed 1 tablet in 24 hours."],"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 Guaifenesin may increase renal clearance for the urate and thereby lower serum uric acid levels. Guaifenesin may produce an increase in urinary 5-hydroxyindoleacetic acid and may therefore interfere with the interpretation of this test for the diagnosis of carcinoid syndrome. It may also falsely elevate the VMA test for catechols. Administration of this drug should be discontinued 48 hours prior to the collection of urine specimens for such tests. Drug Interactions Drug/Laboratory Test Interactions","Drug Interactions"],"effective_time":"20110317","general_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 physiological complications, and that appropriate therapy for the primary disease is instituted. Dextromethorphan should be used with caution in sedated or debilitated patients, and in patients to be confined to the supine-position."],"geriatric_use":["Geriatric Use"],"how_supplied":["HOW SUPPLIED Bottles of 100 scored dye-free tablets embossed with \"MUCOFEN DM\" on one side and blank on the scored side. NDC 59310-119-10. Store at room temperature between 15 o C and 30 o C (59 o F to 86 o F). Dispense in tight, light resistant container with a child resistant closure."],"id":"2f05ee80-dfe8-4f47-a850-30363f2f428f","indications_and_usage":["INDICATIONS AND USAGE MUCO-FEN TM DM tablets are indicated for the temporary relief of coughs associated with upper respiratory tract infections and related conditions such as sinusitis, pharyngitis and bronchitis, particularly when these conditions are complicated by tenacious mucus and/or mucous plugs and congestion. The drug 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 It is not known whether guaifenesin or dextromethorphan is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when these drugs are administered to a nursing woman and a decision should be made whether to discontinue nursing or to discontinue the drugs, taking into account the importance of the drugs to the mother."],"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 nervous system 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 has been reported."],"package_label_principal_display_panel":["PACKAGE/LABEL PRINCIPAL DISPLAY PANEL CONTAINER LABEL 6491 CL"],"pediatric_use":["Pediatric Use"],"precautions":["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 physiological complications, and that appropriate therapy for the primary disease is instituted. Dextromethorphan should be used with caution in sedated or debilitated patients, and in patients to be confined to the supine-position. Information for Patients Laboratory Tests Interactions Guaifenesin may increase renal clearance for the urate and thereby lower serum uric acid levels. Guaifenesin may produce an increase in urinary 5-hydroxyindoleacetic acid and may therefore interfere with the interpretation of this test for the diagnosis of carcinoid syndrome. It may also falsely elevate the VMA test for catechols. Administration of this drug should be discontinued 48 hours prior to the collection of urine specimens for such tests. Drug Interactions Drug/Laboratory Test Interactions Carcinogenesis, Mutagenesis, Impairment of Fertility No data are available on the long-term potential for carcinogenesis, mutagenesis, or impairment of fertility in animals or humans. Pregnancy Category C: Animal reproduction studies have not been conducted with guaifenesin or with dextromethorphan. It is also not known whether these drugs can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. This drug should be given to a pregnant woman only if clearly needed. Teratogenic Effects Nonteratogenic Effects Labor and Delivery Nursing Mothers It is not known whether guaifenesin or dextromethorphan is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when these drugs are administered to a nursing woman and a decision should be made whether to discontinue nursing or to discontinue the drugs, taking into account the importance of the drugs to the mother. Pediatric Use Geriatric Use"],"pregnancy":["Pregnancy Category C: Animal reproduction studies have not been conducted with guaifenesin or with dextromethorphan. It is also not known whether these drugs can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. This drug should be given to a pregnant woman only if clearly needed. Teratogenic Effects Nonteratogenic Effects"],"set_id":"2f05ee80-dfe8-4f47-a850-30363f2f428f","spl_product_data_elements":["MUCO-FEN GUAIFENESIN AND DEXTROMETHORPHAN GUAIFENESIN GUAIFENESIN DEXTROMETHORPHAN HYDROBROMIDE DEXTROMETHORPHAN HYDRIODIDE HYPROMELLOSE 2910 (15000 MPA.S) HYPROMELLOSE 2208 (15000 MPA.S) ANHYDROUS DIBASIC CALCIUM PHOSPHATE SILICON DIOXIDE STEARIC ACID MAGNESIUM STEARATE MUCOFE;DM"],"teratogenic_effects":["Teratogenic Effects"],"version":"1","warnings":["WARNINGS"]}