{"abuse":["Abuse"],"adverse_reactions":["ADVERSE REACTIONS Hyperreactive individuals may display ephedrine-like reactions such as tachycardia, palpitations, headache, dizziness or nausea. Sympathomimetlcs 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 are available on the long··term potential for carcinogenesis, mutagenesis, or impairment of fertility in animals or humans."],"clinical_pharmacology":["CLINICAL PHARMACOLOGY Phenylephrine hydrochloride is a sympathomimetic amine which acts predominantly by a direct action on alpha (α) adrenergic receptors. In therapeutic doses, the drug has no significant stimulant effect on the beta (ß) 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. Guaifanesin is an expectorant which increases respiratory tract fluid secretions 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 bronch. 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 ß-(2-methoxyphenoxy) lactic acid."],"contraindications":["CONTRAINDICATIONS This product 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. Phenylephrine is contraindicated in patients on monoamine oxidase inhibitor (MAO/) therapy and for 14 days after stopping MAOI therapy (see \"Drug Interactions\" section)."],"controlled_substance":["Controlled Substance"],"dependence":["Dependence"],"description":["DESCRIPTION Each Phenylephrine Hydrochloride and Guaifenesin sustained-release tablet contains 30 mg of phenylephrine hydrochloride and 1200 mg of guaifenesin. Inactive Ingredients: hydroxypropyl methylcellulose, povidone, silicon dioxide, magnesium stearate and hydroxypropyl cellulose. Phenylephrine hydrochloride is an orally effective nasal decongestant. Chemically, it is (S)-3-hydroxy-α-[(methyl-amino) methyl]benzene-methanol hydrochloride. Guaifenesin is an expectorant. Chemically, it is 3-(2-methoxyphenoxy)-1,2-propanediol."],"dosage_and_administration":["DOSAGE AND ADMINISTRATION Adults and adolescents (12 years of age and older): one 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 one tablet in 24 hours. Children under 6 years of age: Phenylephrine Hydrochloride and Guaifenesin Sustained-Release Tablets are not recommended for use in children under 6 years of age. Do not crush or chew tablets"],"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, 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-hydroxyindoleacetlc 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 Guaifenesin interferes with the colorimetric determination of 5·hydroxyindoleacetic acid (5-HIAA) and vanillylmandelic acid (VMA). 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. 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-hydroxyindoleacetlc 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":"20110318","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 sympathomimetlcs. OVerdosage of sympathomtmetics in this age group may cause hallucinations, convulsiOns, CNS depression, and death. Demonstrate safe use of a ahol1-acting sympathOmimetic amine before use of a sustained-action 1ormuiatiOn In gerillltric patients.."],"how_supplied":["HOW SUPPLIED Phenylephrine Hydrochloride and Gualfenesin Sustained-Release Tablets are supplied as a white, scored, dye-free, oval shaped caplet embossed with 'Prasco' on one side and '328' on the other in bottles of 100. NDC 66993-328-02. Dispense in a tight, light-resistant container with a child-resistant closure as defined in the USP/NF. Store at room temperature 15° -30°C (59° to 86°F) (see USP)."],"id":"1eb76419-e4ef-4e4c-892a-8b4a5fea67ea","indications_and_usage":["INDICATIONS AND USAGE This product 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 mucous and/or mucous plugs and congestion. This product is effective in a product as well as a non-productive 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; not doubling doses. This medication should be stored in a tight, light-resistant container at temperatures between 15 o -30 o C(59 o -86 o 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 this product by nursing mothers is not recommended because of the higher than usual risk for infants from sympathomimetic amines."],"openfda":{},"overdosage":["OVERDOSAGE This product is comprised of pharmacologica11y different components (phenylephrine and gualfenesin). 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 indlvldual components follows; Signs and symptoms: Overdosage with sympathomimetic amines can cause cardiac arrhythmias, cerebral hemorrhage.and pulmonary edema. It can also cause pelpitation, tremor, dizziness, vomiting, fear labored breathing, headache, dryness of mouth, pallor, weakness, panic, anxiety, confusion, hallucinations, and delirium. 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 5gm/kg, produced no signs of toxicity. 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 activate charcoal and a saline cathartic."],"package_label_principal_display_panel":["PACKAGE/LABEL PRINCIPAL DISPLAY PANEL CONTAINER LABEL 6978 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 a sustained 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; not doubling doses. This medication should be stored in a tight, light-resistant container at temperatures between 15 o -30 o C(59 o -86 o 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 Guaifenesin interferes with the colorimetric determination of 5·hydroxyindoleacetic acid (5-HIAA) and vanillylmandelic acid (VMA). 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. 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-hydroxyindoleacetlc 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 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 this product. It is also not known whether this product can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. This product should be used in 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 this product 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 a sustained 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 sympathomimetlcs. OVerdosage of sympathomtmetics in this age group may cause hallucinations, convulsiOns, CNS depression, and death. Demonstrate safe use of a ahol1-acting sympathOmimetic amine before use of a sustained-action 1ormuiatiOn In gerillltric patients.."],"pregnancy":["Pregnancy Category C. Animal reproduction studies have not been conducted with this product. It is also not known whether this product can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. This product should be used in pregnant woman only if clearly needed. Teratogenic Effects Nonteratogenic Effects"],"set_id":"1eb76419-e4ef-4e4c-892a-8b4a5fea67ea","spl_product_data_elements":["GUAIFENESIN AND PHYENYLEPHRINE HYDROCHLORIDE GUAIFENESIN AND PHYENYLEPHRINE GUAIFENESIN GUAIFENESIN PHENYLEPHRINE HYDROCHLORIDE PHENYLEPHRINE POVIDONE K90 HYPROMELLOSE 2208 (15000 MPA.S) SILICON DIOXIDE MAGNESIUM STEARATE PRA;SCO"],"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 cardiovascular collapse 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."]}