{"abuse":["Abuse"],"adverse_reactions":["ADVERSE REACTIONS Gastrointestinal: Nausea and vomiting. Central Nervous System: Nervousness, diZZiness, Sleeplessness, lightheadedness, tremor, hallucinations, convulsions, CNS depression, fear, anxiety, headache, increased irritability or excitement. Cardiovascular: Palpitations, tachycardia, cardiovascular collapse and death. General: Weakness; slight drowsiness. Respiratory: Respiratory difficulties."],"carcinogenesis_and_mutagenesis_and_impairment_of_fertility":["Carcinogenesis, Mutagenesis, Impairment of Fertility"],"clinical_pharmacology":["CLINICAL PHARMACOLOGY Guaifenesin promotes lower respiratory tract drainage by thinning bronchial secretions, lubricates irritated respiratory tract membranes through increased mucus flow. and facilitates removal of viscous, inspissated mucus. As a result, sinus and bronchial drainage is improved, and dry, nonproductive coughs become more productive and less frequent. Phenyiephrine hydrochloride is an a-adrenergic receptor agonist (sympathomimetic) which produces vasoconstriction by stimulating a-receptors within the mucosa of the respiratory tract. Clinically, phenylephrine shrinks swollen mucous membranes, reduces tissue hyperemia, edema, and nasal congestion, and increases nasal airway potency. 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 dosages, it 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 Patients with a known hypersensitivity to any of its ingredients, in nursing mothers, or in patients with severe hypertension, severe coronary artery disease, prostatic hypertrophy, or in patients on MAO inhibitor therapy."],"controlled_substance":["Controlled Substance"],"dependence":["Dependence"],"description":["DESCRIPTION Each extended release tablet contains: Guaifenesin........................................ 1200 mg Phenylephrine HCI .............................. 30 mg Dextromethorphan Hydrobromide ........ 30 mg Duraphen TM Forte is fomulated in a special base to provide a prolonged therapeutic effect. This product contains ingredients of the following therapeutic classes: expectorant. nasal decongestant and antitussive. Gualfenesin is an expectorant having the chemical name, 1,2-propanediol, 3-(2-methoxyphenoxy). Phenylephrine hydrochloride is a decongestant having the chemical name, benzenemethanol, 3-hydroxy-a-[(methylamino)methyl]-. hydrochloride. Dextromethorphan hydrobromide is a salt of the methylether of the dextrorotatory isomer of levorphanol, a narcotic analgesic. and is an antitussive having the chemical name: morphinan, 3-methoxy-17-methyl-, (9α, 13α, 14α), hydrobromide, monohydrate."],"dosage_and_administration":["DOSAGE AND ADMINISTRATION Adults and adolescents 12 years of age and older: One tablet twice daily not to exceed 2 tablets in 24 hours. Children 6 to 12 years: One half (112) tablet every 12 hours not to exceed 1 tablet in 24 hours. Not recommended for children under 6 years of age. Tablets may be broken in half for ease of administration. Geriatric patients may be more sensitive to the effects of this medication. Adjust adult dose accordingly. DO NOT CRUSH OR CHEW TABLETS PRIOR TO SWALLOWING."],"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 intertere with clinical laboratory determinations of urinary 5-hydroxyindoleacetic acid (5-HIAA) and urinary vanillylmandelic acid (VMA)"],"drug_interactions":["Interactions Drug Interactions Monoamine oxidase (MAO) inhibitors and beta adrenergic blockers increase the effects of sympathomimetic amines, Sympathomimetic amines may reduce the antihypertensive effects of methyldopa, guanethidine, mecamylamine, reserpine and veratrum alkaloids Drug/Laboratory Test Interactions Guaifenesin has been reported to intertere with clinical laboratory determinations of urinary 5-hydroxyindoleacetic acid (5-HIAA) and urinary vanillylmandelic acid (VMA)","Drug Interactions Monoamine oxidase (MAO) inhibitors and beta adrenergic blockers increase the effects of sympathomimetic amines, Sympathomimetic amines may reduce the antihypertensive effects of methyldopa, guanethidine, mecamylamine, reserpine and veratrum alkaloids"],"effective_time":"20110315","general_precautions":["General Hypertensive patients should use only with medical advice, as they may experience a change in blood pressure due to added vasoconstriction."],"geriatric_use":["Geriatric Use Patients 60 years and older are more likely to experience adverse reactions to sympathomimetics. Overdose may cause hallucinations, convulsions, CNS depression and death. Demonstrate safe use of a short-acting sympathomimetic before use of a sustained action formulation in elderly patients."],"how_supplied":["HOW SUPPLIED Duraphen™ Forte is available in a dye-free scored tablet debossed with \"PE 805\" on the scored side, and plain on the other. Bottles of 100s NDC-66869-805-10. KEEP THIS AND ALL MEDICATION OUT OF THE REACH OF CHIL· OREN. IN CASE OF ACCIDENTAL OVERDOSE, SEEK PROFESSIONAL ASSISTANCE OR CONTACT A POISON CONTROL CENTER IMMEDIATELY. Dispense in a tight, light-resistant container as defined in the USP/NF. Store at controlled room temperature 20 o ·25°C (68°-77 o F)."],"id":"30c0b773-5d19-4b34-ae3d-1fedbe7c6038","indications_and_usage":["INDICATIONS AND USAGE Duraphen™ Forte helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus, drain bronchial tubes. and make coughs more productive. To provide temporary relief of coughs and upper respiratory symptoms characterized by dry nonproductive coughs. Duraphen TM Forte is also indicated for The relief of nasal congestion due to the common cold, hay fever, or other respiratory allergies and nasal congestion associated with sinusitis."],"information_for_patients":["Information for Patients Persistent cough may indicate a serious condition. If cough persists for more than one week, tends to recur, or is accompanied by a high fever, rash, or persistent headache, consult a physician."],"labor_and_delivery":["Labor and Delivery"],"laboratory_tests":["Laboratory Tests"],"nonteratogenic_effects":["Nonteratogenic Effects"],"nursing_mothers":["Nursing Mothers Contraindicated in the nursing mother because of the higher than usual risks to infants from sympathomimetic agents."],"openfda":{},"overdosage":["OVERDOSAGE Symptoms: Overdosage may cause hallucinations, convulsions, CNS depression, cardiovascular collapse and death. Overdosage with dextromethorphan HBr may produce nausea and vomiting, central nervous system excitement and mental confusion, visual disturbances, and urinary retention. Very high doses may produce respiratory depression. One case of toxic psychosis (hyper-reactivity, marked visual and auditory hallucinations) after a single 300 mg dose of dextromethorphan has been reported. Treatment: Treatment of overdosage should provide symptomatic care. If the amount ingested is considered dangerous or excessive, induce vomiting with ipecac syrup unless the patient is convulsing, comatose, or has lost the gag reflex, in which case perform gastric lavage using a largebore tube. If indicated, follow with activated charcoal and a saline cathartic. Since the effects of this product may last up to 12 hours, treatment should be continued for at least that length of time."],"package_label_principal_display_panel":["PACKAGE/LABEL PRINCIPAL DISPLAY PANEL CONTAINER LABEL 6817 CL"],"pediatric_use":["Pediatric Use Safety and effectiveness in pediatric patients below the age of 6 has not been estabiished."],"precautions":["PRECAUTIONS General Hypertensive patients should use only with medical advice, as they may experience a change in blood pressure due to added vasoconstriction. Information for Patients Persistent cough may indicate a serious condition. If cough persists for more than one week, tends to recur, or is accompanied by a high fever, rash, or persistent headache, consult a physician. Laboratory Tests Interactions Drug Interactions Monoamine oxidase (MAO) inhibitors and beta adrenergic blockers increase the effects of sympathomimetic amines, Sympathomimetic amines may reduce the antihypertensive effects of methyldopa, guanethidine, mecamylamine, reserpine and veratrum alkaloids Drug/Laboratory Test Interactions Guaifenesin has been reported to intertere with clinical laboratory determinations of urinary 5-hydroxyindoleacetic acid (5-HIAA) and urinary vanillylmandelic acid (VMA) Carcinogenesis, Mutagenesis, Impairment of Fertility Pregnancy Category C: Animal reproduction studies have not been conducted with Duraphen™ Forte tablets. It is also not known whether this product can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Product should be given to a pregnant woman only it clearly needed Teratogenic Effects Nonteratogenic Effects Labor and Delivery Nursing Mothers Contraindicated in the nursing mother because of the higher than usual risks to infants from sympathomimetic agents. Pediatric Use Safety and effectiveness in pediatric patients below the age of 6 has not been estabiished. Geriatric Use Patients 60 years and older are more likely to experience adverse reactions to sympathomimetics. Overdose may cause hallucinations, convulsions, CNS depression and death. Demonstrate safe use of a short-acting sympathomimetic before use of a sustained action formulation in elderly patients."],"pregnancy":["Pregnancy Category C: Animal reproduction studies have not been conducted with Duraphen™ Forte tablets. It is also not known whether this product can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Product should be given to a pregnant woman only it clearly needed Teratogenic Effects Nonteratogenic Effects"],"set_id":"30c0b773-5d19-4b34-ae3d-1fedbe7c6038","spl_product_data_elements":["DURAPHEN Guaifenesin, Phenylepherine, and Dextromethorphan GUAIFENESIN GUAIFENESIN PHENYLEPHRINE HYDROCHLORIDE PHENYLEPHRINE DEXTROMETHORPHAN HYDROBROMIDE DEXTROMETHORPHAN HYPROMELLOSE 2910 (15000 MPA.S) HYPROMELLOSE 2208 (15000 MPA.S) ANHYDROUS DIBASIC CALCIUM PHOSPHATE SILICON DIOXIDE STEARIC ACID MAGNESIUM STEARATE PE;805"],"teratogenic_effects":["Teratogenic Effects"],"version":"1","warnings":["WARNINGS Sympathomimetic amines should be used with caution in patients with hypertension, diabetes mellitus, heart disease, peripheral vascular disease, increased infraocular pressure, hyperthyroidism, or prostatic hypertrophy."]}