{"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. Guaifenesin has a plasma half-life of one hour. The major urinary metabolite is 8-(2methoxyphenoxy) lactic acid. Phenytephrine hydrochloride is a sympathomimetic amine' wl1ich acts predominantly' bya 'dlreb1 action on alpha (a)-adrenergic receptors. In therapeutic doses, the drug has no significant stimulant effect on the beta (8)-adrenergic receptors of the heart. Clinically, phenylephrine shrinks swollen mucous 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 1000 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.................................... 1000 mg Phenylephrine HCI ........................ 30 mg Duraphen 1000 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 1000 may also contain the following inactive ingredients: hydroxypropyl methylcellulose, polyvinylpyrrolidone, silicon dioxide, magnesium stearate, and hydroxypropyl cellulose. Gualfenesin: 1,2-propanediol, 3-(2-methoxyphenoxy)-, is a white to slightly gray, crystalline powder, having a bitter 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-[(methylamino) methyl] 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 1000 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 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":["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 alkaloids. Concurrent use of tricyclic antidepressants may antagonize the effects of phenylephrine. Use of other vasopressor drugs during halothane anesthesia may cause serious cardiac arrhythmias Drug/Laboratory Test 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 alkaloids. Concurrent use of tricyclic antidepressants may antagonize the effects of phenylephrine. 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 1000 is a white, capsule-shaped tablet scored and debossed with \"PE 669\" on one side, and plain on the other side. Supplied in bottles of 100, NDC 66869-669-10. KEEP THIS AND All MEDICATIONS OUT OF THE REACH OF CHILDREN. 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 USP/NF with a child-resistant closure. Storage: Store at controlled room temperature, 15 o -30 o C (59 o - 86 o F)."],"id":"f87b316e-196b-49ae-97cb-04754467432a","indications_and_usage":["INDICATIONS AND USAGE Duraphen 1000 is indicated for temporarily relieving symptoms of upper respiratory tract disorders such as sinusitis 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 1000 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: Do not take more medication than the amount recommended. Take medication with food, water, or milk to minimize gastric irritation. Do not crush or chew tablets. Do not take monoamine oxidase inhibitors while taking this medication. If a dose is missed, the medication should be taken as soon as possible unless it is almost time for the next dose; no doubling doses. Duraphen 1000 should be stored in a tight, light-resistant container at temperatures between 15°-30°C (59°-86°F). Keep this and all medications out of the 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 1000 by nursing mothers is not recommended because of the higher than usual risk for infants from sympathomimetic amines."],"openfda":{},"overdosage":["OVERDOSAGE Duraphen 1000 is comprised of pharmacologically different components (guaifenesin and phenylephrine). Therefore, it is difficult to predict the exact manifesta1ion 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 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 gm/kg, produced no signs of toxicity. Overdosage with sympathomimetic amines can cause cardiac arrhythmias, 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 the 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 1000 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 6997 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: Do not take more medication than the amount recommended. Take medication with food, water, or milk to minimize gastric irritation. Do not crush or chew tablets. Do not take monoamine oxidase inhibitors while taking this medication. If a dose is missed, the medication should be taken as soon as possible unless it is almost time for the next dose; no doubling doses. Duraphen 1000 should be stored in a tight, light-resistant container at temperatures between 15°-30°C (59°-86°F). Keep this and all medications out of the reach of children. In case of an accidental overdose, seek professional assistance or contact a poison control center immediately. Laboratory Tests 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 alkaloids. Concurrent use of tricyclic antidepressants may antagonize the effects of phenylephrine. Use of other vasopressor drugs during halothane anesthesia may cause serious cardiac arrhythmias Drug/Laboratory Test 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. 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 Category C: Animal reproduction studies have not been conducted with Duraphen 1000. It is also not known whether Duraphen 1000 can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Duraphen 1000 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 1000 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 Category C: Animal reproduction studies have not been conducted with Duraphen 1000. It is also not known whether Duraphen 1000 can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Duraphen 1000 should be given to a pregnant woman only if clearly needed. Teratogenic Effects Nonteratogenic Effects"],"set_id":"f87b316e-196b-49ae-97cb-04754467432a","spl_product_data_elements":["DURAPHEN 1000 Guaifenesin and Phenylephrine GUAIFENESIN GUAIFENESIN PHENYLEPHRINE HYDROCHLORIDE PHENYLEPHRINE CROSPOVIDONE HYPROMELLOSE 2208 (15000 MPA.S) SILICON DIOXIDE MAGNESIUM STEARATE PE;669"],"teratogenic_effects":["Teratogenic Effects"],"version":"1","warnings":["WARNINGS Sympathomimetic amines should be used judiciously and sparingly in patients with hypertension, diabetes mellitus, ischemic heart disease, increased intraocular pressure, hyperthyroidism or prostatic hypertrophy. Sympathomimetics may produce central nervous system stimulation with convulsions or Check with physician if cough persists after medication has been used for 7 days or if high fever, skin rash, or continuedcollapse with accompanying hypotension. Do not exceed recommended dosage. Hypertensive crises can occur with concurrent use of phenylephrine and MAO inhibitors (and for 14 days after stopping MAOI therapy), indomethacin, or with betablockers 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."]}