{"abuse":["Abuse"],"adverse_reactions":["ADVERSE REACTIONS Sympathomimetic amines may cause tachycardia, palpitations, nervousness, insomnia, restlessness, headache, gastric irritation, and irritability. Sympathomimetic amines have been associated with certain untoward reactions including fear, anxiety, tenseness, restlessness, tremor, weakness, pallor, respiratory difficulty, dysuria, insomnia, hallucinations, convulsions, CNS depression, arrhythmias and cardiovascular collapse with hypotension. Urinary retention may occur in patients with prostate hypertrophy. Guaifenesin may cause nausea, vomiting, diarrhea, and gastric irritation."],"carcinogenesis_and_mutagenesis_and_impairment_of_fertility":["Carcinogenesis, Mutagenesis, Impairment of Fertility"],"clinical_pharmacology":["CLINICAL PHARMACOLOGY Dextromethorphan hydrobromide 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 approximately equal to codeine in depressing the cough reflex. In therapeutic dosage, dextromethorphan hydrobromide does not inhibit ciliary activity. Dex1romethorphan hydrobromide is rapidly absorbed from the gastrointestinal tract, metabolized by the liver and excreted primarily in the urine. Pseudoephedrine hydrochloride is an orally indirect acting sympathomimetic amine and exerts a decongestant action on the nasal mucosa. It does this by vasoconstriction which results in reduction of tissue hyperemia, edema, nasal congestion, and an increase in nasal airway patency. The vasoconstriction action of pseudoephedrine is similar to that of ephedrine. In the usual dose it has minimal vasopressor effects. Pseudoephedrine is rapidly and almost completely absorbed from the gastrointestinal tract. It has a plasma half life of 6 to 8 hours. Alkaline urine is associated with slower elimination 01 the drug. The drug is distributed to body tissues and flUids, including the central nervous system (CNS). Approximately 50% to 75% of the administered dose is excreted unchanged in the urine; the remainder is apparently metabolized in the liver to inactive compounds by N-demethylation, parahydroxylation, and oxidative deamination. Guailenesin promotes lower respiratory tract drainage by thinning bronchial secretions. and facilitates removal of viscous, inspissated mucus. By reducing the viscosity of secretions, guaifenesin increases the efficiency of the cough reflex and of the ciliary action in removing accumulated secretions from the trachea and bronchi."],"contraindications":["CONTRAINDICATIONS Patients with hypersensitivity or idiosyncrasy to any of its ingredients. Sympathomimetic amines are contraindicated in patients with severe hypertension, severe coronary artery disease and patients on MAO inhibitor therapy."],"controlled_substance":["Controlled Substance"],"dependence":["Dependence"],"description":["DESCRIPTION Each PROFEN FORTE DM white scored, capsule-shaped tablet for oral administration contains: Dextromethorphan HBr .......................... 60 mg Pseudoephedrine HCI ............................. 90 mg Guaifenesin ........................................... 800 mg in a special base to provide a prolonged therapeutic effect. Dextromethorphan hydrobromide is a salt of the methyl ether of the dextrorotatory isomer of levorphanol, a narcotic analgesic, and is an antitussive having the chemical name: morphinan, 3-methoxy-17methyl-. (9α, 13α, 14α)-, hydrobromide, monohydrate. Pseudoephedrine Hydrochloride is an adrenergic (vasoconstrictor) having the chemical name benzenemathanol, α-[1-(methylamino)ethyl]-, [S-(R*,R*)]-, hydrochloride. Guaifenesin is an expectorant having the chemical name, 1,2-propanediol, 3-(2-methoxyphenoxy). Inactive Ingredients: Hydroxypropyl methylcellulose, dibasic calcium phosphate, stearic acid. magnesium stearate, silicon dioxide."],"dosage_and_administration":["DOSAGE AND ADMINISTRATION Usual Dosage: Adults and children 12 years or older -one or one and a half tablets every 12 hours not to exceed three tablets in 24 hours. Children 6-12 years of age -one-half tablet every 12 hours not to exceed one tablet in 24 hours. Tablets may be broken in half for ease of administration without affecting release of medication. but should not be crushed or chewed prior to swallowing. This product is not recommended for children under 6 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 Guaifenesin has been reported to interfere with clinical laboratory determinations of urinary 5-hydroxyindoleacetic acid (5HIAA) and urinary vanillylmandelic acid (VMA)."],"drug_interactions":["Interactions Drug Interactions Monoamine oxidase (MAO) inhibitors and beta-adrenergic blockers increase the effect of sympathomimetic amines. Sympathomimetic amines may reduce the antihypertensive effects of methyldopa, mecamylamine and reserpine. Drug/Laboratory Test Interactions Guaifenesin has been reported to interfere with clinical laboratory determinations of urinary 5-hydroxyindoleacetic acid (5HIAA) and urinary vanillylmandelic acid (VMA).","Drug Interactions Monoamine oxidase (MAO) inhibitors and beta-adrenergic blockers increase the effect of sympathomimetic amines. Sympathomimetic amines may reduce the antihypertensive effects of methyldopa, mecamylamine and reserpine."],"effective_time":"20110318","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. Should be used with caution in patients with diabetes, hypertension, cardiovascular disease or hyperreactivity to sympathomimetic amines."],"geriatric_use":["Geriatric Use"],"how_supplied":["HOW SUPPLIED PROFEN FORTE DM is available as a white, scored tablet debossed with \"PROFEN FORTE DM\" on one side and blank on the scored side. Bottles of 100's NDC 59310-310-10. Store at room temperature, 15 o -30 o C (59 o -86 o F). Dispense in tight, light-resistant containers (USP/NF)."],"id":"ea1600a2-e0af-4f6c-ab45-1160d3682449","indications_and_usage":["INDICATIONS AND USAGE PROFEN FORTE DM is indicated for the temporary symptomatic relief of sinusitis, bronchitis, pharyngitis. nonproductive cough and the common cold when these conditions are associated with nasal congestion and viscous mucus in the lower respiratory tract."],"information_for_patients":["Information for Patients Do not crush or chew PROFEN FORTE DM tablets prior to swallowing."],"labor_and_delivery":["Labor and Delivery"],"laboratory_tests":["Laboratory Tests"],"nonteratogenic_effects":["Nonteratogenic Effects"],"nursing_mothers":["Nursing Mothers It is not known whether the drugs in PROFEN FORTE DM are excreted in human milk. Because many drugs are excreted in human milk and because of the potential for serious adverse reactions in nursing infants, a decision should be made whether to discontinue nursing or discontinue the product, taking into account the importance of the drug to the mother."],"openfda":{},"overdosage":["OVERDOSAGE The treatment of overdosage should provide symptomatic and supportive care. Induction of emesis and gastric lavage may be performed if the patient is alert and seen within ear1y hours after ingestion. Drug remaining in the stomach may be absorbed by the administration of activated charcoal. Stimulants should not be used because they may precipitate convulsions. Use of short-acting barbiturate is recommended if convulsions or marked CNS excitement occur. Since the effects of PROFEN FORTE DM may last up to 12 hours, the patient should be monitored for at least that length of time and treated as necessary."],"package_label_principal_display_panel":["PACKAGE/LABEL PRINCIPAL DISPLAY PANEL CONTAINER LABEL 6489 CL"],"pediatric_use":["Pediatric Use Safely and effectiveness of PROFEN FORTE DM in children below the age of 6 have not been established."],"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. Should be used with caution in patients with diabetes, hypertension, cardiovascular disease or hyperreactivity to sympathomimetic amines. Information for Patients Do not crush or chew PROFEN FORTE DM tablets prior to swallowing. Laboratory Tests Interactions Drug Interactions Monoamine oxidase (MAO) inhibitors and beta-adrenergic blockers increase the effect of sympathomimetic amines. Sympathomimetic amines may reduce the antihypertensive effects of methyldopa, mecamylamine and reserpine. Drug/Laboratory Test Interactions Guaifenesin has been reported to interfere with clinical laboratory determinations of urinary 5-hydroxyindoleacetic acid (5HIAA) and urinary vanillylmandelic acid (VMA). Carcinogenesis, Mutagenesis, Impairment of Fertility Pregnancy Category C: Animal reproduction studies have not been conducted with PROFEN II DM. It is also not known whether PROFEN FORTE DM can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. PROFEN FORTE DM should be given to a pregnant woman only if clear1y needed. Teratogenic Effects Nonteratogenic Effects Labor and Delivery Nursing Mothers It is not known whether the drugs in PROFEN FORTE DM are excreted in human milk. Because many drugs are excreted in human milk and because of the potential for serious adverse reactions in nursing infants, a decision should be made whether to discontinue nursing or discontinue the product, taking into account the importance of the drug to the mother. Pediatric Use Safely and effectiveness of PROFEN FORTE DM in children below the age of 6 have not been established. Geriatric Use"],"pregnancy":["Pregnancy Category C: Animal reproduction studies have not been conducted with PROFEN II DM. It is also not known whether PROFEN FORTE DM can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. PROFEN FORTE DM should be given to a pregnant woman only if clear1y needed. Teratogenic Effects Nonteratogenic Effects"],"set_id":"ea1600a2-e0af-4f6c-ab45-1160d3682449","spl_product_data_elements":["PROFEN DEXTROMETHORPHAN, PSEUDOEPHEDRINE, and GUAIFENESIN GUAIFENESIN GUAIFENESIN PSEUDOEPHEDRINE HYDROCHLORIDE PSEUDOEPHEDRINE DEXTROMETHORPHAN HYDROBROMIDE DEXTROMETHORPHAN HYDRIODIDE HYPROMELLOSE 2910 (15000 MPA.S) HYPROMELLOSE 2910 (5 MPA.S) ANHYDROUS DIBASIC CALCIUM PHOSPHATE SILICON DIOXIDE STEARIC ACID MAGNESIUM STEARATE PROFEN;FORTE;DM;316"],"teratogenic_effects":["Teratogenic Effects"],"version":"1","warnings":["WARNINGS Sympathomimetic amines should be used judiciously and sparingly in patients with hypertension, diabetes, ischemic heart disease, hyperthyroidism, increased intraocular pressure and prostatic hypertrophy. See Contraindications. Sympathomimetic amines may produce CNS stimulation and convulsions or cardiovascular collapse with accompanying hypotension. The elderly (60 years and older) are more likely to exhibit adverse reactions. Do not exceed recommended dosage."]}