{"abuse":["Abuse"],"adverse_reactions":["ADVERSE REACTIONS Hyperreactive individuals may display ephedrine-like reactions such as tachycardia, palpitations, headache, dizziness, or nausea. Sympathomimetic amines 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 from guaifenesin have been reported."],"carcinogenesis_and_mutagenesis_and_impairment_of_fertility":["Carcinogenesis, Mutagenesis, Impairment of Fertility No data is 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 secretions and helps 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. 6uaifenesin has a plasma half-life of one hour. The major urinary metabolite is {3 -(2methoxyphenoxy) lactic acid. Phenylephrine hydrochloride is a sympathomimetic amine which acts predominantly by a direct action on alpha (a )-adrenergic receptors. In therapeutic doses, the drug has no significant effect on the beta ({3)-adrenergic receptors of the heart. Clinically, phenylephrine shrinks swollen mucus membranes, reduces tissue hyperemia, edema, and nasal congestion; and increases nasal airway patency. In therapeutic doses the drug causes little, if any, central nervous system (CNS) stimulation."],"contraindications":["CONTRAINDICATIONS Duraphen™ II is contraindicated in patients with hypersensitivity to guaifenesin or with hypersensitivity or idiosyncrasy to sympathomimetic amines which may be manifested by insomnia, dizziness, weakness, tremor or arrhythmias. Patients known to be hypersensitive to other sympathomimetic amines may exhibit cross sensitivity with phenylephrine. Phenylephrine is contraindicated in patients with hypertension or ventricular tachycardia and should be employed only with extreme caution in elderly patients or in patients with hyperthyroidism, bradycardia, partial heart block, myocardial disease, or severe arteriosclerosis. It is also contraindicated in patients on monoamine oxidase inhibitor (MAOI) therapy and for 14 days after stopping MAOI therapy (see \"Drug Interactions\" section)."],"controlled_substance":["Controlled Substance"],"dependence":["Dependence"],"description":["DESCRIPTION Each extended-release tablet contains: Guaifenesin........................................ 800 mg Phenylephrine Hydrochloride ............. 25 mg Duraphen™ II is formulated in a· special base to provide a prolonged therapeutic effect. This product contains ingredients of the following therapeutic classes: expectorant and decongestant. Duraphen II also contains the following inactive ingredients: hydroxypropyl methylcellulose, plasdone, stearic acid, magnesium stearate, silicone dioxide, hydroxypropyl cellulose, talc, water. Guaifenesin: 1,2-Propanediol, 3-(2-methoxyphenoxy)-, is a white to slighly gray, crystalline powder, having abitter taste. It may have a slight characteristic odor. It is soluble in water, alcohol, chloroform, glycerin, and propylene glycol. Phenylephrine hydrochloride: (R)-3-Hydroxy-α-[methylamine) methy] Benzenemethanol hydrochloride is an adrenergic which occurs as white or practically white, odorless crystals, having a bitter taste. It is freely soluble in water and in alcohol."],"dosage_and_administration":["DOSAGE AND ADMINISTRATION Adults and children over 12 years of age: 1 tablet every 12 hours, not to exceed 2 tablets in 24 hours. Children 6 to 12 years of age: 1/2 tablet every 12 hours, not to exceed 1 tablet in 24 hours. Duraphen II is not recommended for children under 6 years of age. 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."],"drug_abuse_and_dependence":["DRUG ABUSE AND DEPENDENCE Central nervous system stimulants have been abused. At high doses, subjects commonly experience an elevation of mood, a sense of increased energy and alertness, and decreased appetite. Some individuals become anxious, irritable, and loquacious. In addition to the marked euphoria, the user experiences a sense of markedly enhanced physical strength and mental capacity. With continued use, tolerance develops. The user increases the dose, and toxic signs and symptoms appear. Depression may follow rapid withdrawal. Controlled Substance Abuse Dependence"],"drug_and_or_laboratory_test_interactions":["Drug/Laboratory Test Interactions"],"drug_interactions":["Interactions Guaifenesin may increase renal clearance for 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 the drug should be discontinued 48 hours prior to the collection of urine specimens for such tests. Drug Interactions Beta-adrenergic blockers and MAO inhibitors may potentiate the pressor effect of phenylephrine. 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 alkaliods. Concurrent use of tricyclic antidepressants may antagonize the effects of phenylephine. Use of other vasopressor drugs during halothane anesthesia may cause serious cardiac arrhythmias. Drug/Laboratory Test Interactions","Drug Interactions Beta-adrenergic blockers and MAO inhibitors may potentiate the pressor effect of phenylephrine. 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 alkaliods. Concurrent use of tricyclic antidepressants may antagonize the effects of phenylephine. Use of other vasopressor drugs during halothane anesthesia may cause serious cardiac arrhythmias."],"effective_time":"20110315","general_precautions":["General Check with physician if cough persists after medication has been used for 7 days or if high fever, skin rash, or continued headache, or sore throat is present with cough."],"geriatric_use":["Geriatric Use (Patients Approximately 60 Years And Older) Geriatric patients are more likely to experience adverse reactions to sympathomimetics. Overdosage of sympathomimetics in this age group may cause hallucinations, convulsions, CNS depression, and death. Demonstrate safe use of a short-acting sympathomimetic amine before use of an extended-action formulation in geriatric patients."],"how_supplied":["HOW SUPPLIED Duraphen TM II is a white, scored, oval-shaped, tablet embossed \"PE 822\" on one side and plain on the other side. Supplied in bottles of 100. NDC 66869-822-10. KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN. IN CASE OF ACCIDENTAL OVER· DOSE, SEEK PROFESSIONAL ASSISTANCE OR CONTACT A POISON CONTROL CENTER IMMEDIATELY. Dispense in a tight, light-resistant container with a child resistant closure as defined in the USP/NF. Store at controlled room temperature, 15°-30°C (59°-86°F)."],"id":"ca4acaa8-1df3-46b3-a37c-35547ed1b20a","indications_and_usage":["INDICATIONS AND USAGE Duraphen™ II is indicated for temporarily relieving symptoms of upper respiratory tract disorders such as sinusitis, vasomotor rhinitis and hay fever; as well as for the temporary relief of coughs associated with respiratory tract infections and related conditions such as sinusitis, pharyngitis, bronchitis, and asthma, when these conditions are complicated by tenacious mucus and/or mucus plugs and congestion. Duraphen II is effective in a productive as well as a nonproductive cough, but is of particular value in a dry, nonproductive cough which tends to injure the mucous membrane of the air passages."],"information_for_patients":["Information for Patients Patient consultation should include the following information regarding proper use of this medication: o Do not take more than the amount recommended. o Take medication with food, water, or milk to minimize gastric irritation. ° If a dose is missed, the medication should be taken as soon as possible unless it is almost time for the next dose; not doubling doses. o Duraphen II should be stored in a tight, light-resistant container at temperatures between 15°-30 o C (59 o -86 o F). o Keep this and all medications out of reach of children. In case of an accidental overdose, seek professional assistance or contact a poison control center immediately."],"labor_and_delivery":["Labor and Delivery"],"laboratory_tests":["Laboratory Tests"],"nonteratogenic_effects":["Nonteratogenic Effects"],"nursing_mothers":["Nursing Mothers Small amounts of phenylephrine are excreted in breast milk. Use of Duraphen™ II by nursing mothers is not recommended because of the higher than usual risk for infants from sympathomimetic amines."],"openfda":{},"overdosage":["OVERDOSAGE Duraphen™ II is comprised of pharmacologically different components (guaifenesin and phenylephrine). Therefore, it is difficult to predict the exact manifestation of symptoms in a given individual. A description of symptoms which are likely to appear after ingestion of an excess of individual components follows: Signs and symptoms: Overdosage with gualfenesin is unlikely to produce toxic effects since its toxicity is low. Guaifenesin, when administered by stomach tube test to animals in doses up to 5gm/kg, produced no signs of toxicity. Overdosage with sympathomimetic amines can cause cardiac arrythmias, cerebral hemorrhage and pulmonary edema. It can also cause palpitation, tremor, dizziness, vomiting, fear, labored breathing, headache, dryness of mouth, pallor, weakness, panic, anxiety, confusion, hallucinations, and delirium. Treatment: Treatment of acute overdosage would probably be based upon treating the patient for symptoms of overdosage of phenylephrine as follows: The treatment of overdosage should provide symptomatic and supportive 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 large bore tube. If indicated, follow with activated charcoal and a saline cathartic. Since the effects of Duraphen II 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 7034 CL"],"pediatric_use":["Pediatric Use Very young children may be more sensitive to the effects, especially the vasopressor effects, of sympathomimetic amines like phenylephrine. Demonstrate safe use of a short-acting sympathomimetic amine before use of an extended-action formulation in pediatric patients. Appropriate studies on the relationship of age to the effects of guaifenesin have not been performed in the pediatric population. However, no pediatric-specific problems have been documented to date."],"precautions":["PRECAUTIONS General Check with physician if cough persists after medication has been used for 7 days or if high fever, skin rash, or continued headache, or sore throat is present with cough. Information for Patients Patient consultation should include the following information regarding proper use of this medication: o Do not take more than the amount recommended. o Take medication with food, water, or milk to minimize gastric irritation. ° If a dose is missed, the medication should be taken as soon as possible unless it is almost time for the next dose; not doubling doses. o Duraphen II should be stored in a tight, light-resistant container at temperatures between 15°-30 o C (59 o -86 o F). o Keep this and all medications out of reach of children. In case of an accidental overdose, seek professional assistance or contact a poison control center immediately. Laboratory Tests Interactions Guaifenesin may increase renal clearance for 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 the drug should be discontinued 48 hours prior to the collection of urine specimens for such tests. Drug Interactions Beta-adrenergic blockers and MAO inhibitors may potentiate the pressor effect of phenylephrine. 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 alkaliods. Concurrent use of tricyclic antidepressants may antagonize the effects of phenylephine. Use of other vasopressor drugs during halothane anesthesia may cause serious cardiac arrhythmias. Drug/Laboratory Test Interactions Carcinogenesis, Mutagenesis, Impairment of Fertility No data is available on the long-term potential for carcinogenesis, mutagenesis, or impairment of fertility in animals or humans. Pregnancy Catergory C: Animal reproduction studies have not been conducted with Duraphen™ II. It is also not known whether Duraphen™ II can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Duraphen™ II should be given to a pregnant woman only if clearly needed. Teratogenic Effects Nonteratogenic Effects Labor and Delivery Nursing Mothers Small amounts of phenylephrine are excreted in breast milk. Use of Duraphen™ II by nursing mothers is not recommended because of the higher than usual risk for infants from sympathomimetic amines. Pediatric Use Very young children may be more sensitive to the effects, especially the vasopressor effects, of sympathomimetic amines like phenylephrine. Demonstrate safe use of a short-acting sympathomimetic amine before use of an extended-action formulation in pediatric patients. Appropriate studies on the relationship of age to the effects of guaifenesin have not been performed in the pediatric population. However, no pediatric-specific problems have been documented to date. Geriatric Use (Patients Approximately 60 Years And Older) Geriatric patients are more likely to experience adverse reactions to sympathomimetics. Overdosage of sympathomimetics in this age group may cause hallucinations, convulsions, CNS depression, and death. Demonstrate safe use of a short-acting sympathomimetic amine before use of an extended-action formulation in geriatric patients."],"pregnancy":["Pregnancy Catergory C: Animal reproduction studies have not been conducted with Duraphen™ II. It is also not known whether Duraphen™ II can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Duraphen™ II should be given to a pregnant woman only if clearly needed. Teratogenic Effects Nonteratogenic Effects"],"set_id":"ca4acaa8-1df3-46b3-a37c-35547ed1b20a","spl_product_data_elements":["DURAPHEN II GUAIFENESIN AND PHENYLEPHRINE GUAIFENESIN GUAIFENESIN PHENYLEPHRINE HYDROCHLORIDE PHENYLEPHRINE POVIDONE K30 HYPROMELLOSE 2208 (15000 MPA.S) SILICON DIOXIDE STEARIC ACID TALC PE;822"],"teratogenic_effects":["Teratogenic Effects"],"version":"1","warnings":["WARNINGS Sympathomimetic amines should be used judiously and sparingly in patients with hypertension, diabetes meltitus, ischemic heart disease, increased intraocular pressure, hyperthyroidism or prostatic hypertrophy. Sympathomimetics may produce central nervous system stimulation with convulsions or cardiovascular collapse with accompanying hypotension. Do not exceed recommended dosage. Hypersensitive crises can occur with concurrent use of phenylephrine and MAO inhibitors (and for 14 days after stopping MAOI therapy), 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. Before prescribing medication to suppress or modify a cough, it is important that the underlying cause of the cough is identified, that modification of the cough does not increase the risk of clinical or physiological complications, and that appropriate therapy for the primary disease is instituted."]}