{"abuse":["Abuse"],"adverse_reactions":["ADVERSE REACTIONS Hyperreactive individuals may display ephedrine-like reactions such as tachycardia, palpitations. headache. dizziness or nausea. Sympathomimetics 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. Guaitenesin is well tolerated and has a wide margin of safety. Side effects are generally mild and infrequen. Nausea and vomiting are the most frequently occurring side effects."],"carcinogenesis_and_mutagenesis_and_impairment_of_fertility":["Carcinogenesis, Mutagenesis, Impairment of Fertility There are no animal or in vitro studies on the combination product phenylephrine hydrochloride and guaifenesin to evaluate carcinogenesis, mutagenesis, and impairment of fertility."],"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. Guaifenesin 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 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-1H2-methoKypheooxy) lactic-acid."],"contraindications":["CONTRAINDICATIONS Phenylephrine Hydrochloride and Guaifenesin Tablets are contraindicated in individuals with known hypersensitivity to sympathomimetics, severe hypertension or in patients receiving MAO inhibitors."],"controlled_substance":["Controlled Substance"],"dependence":["Dependence"],"description":["DESCRIPTION Each tablet contains: Phenylephrine Hydrochloride................................ 25 mg Guaifenesin.......................................................... 900 mg Phenylephrine HCI and Guaifenesin tablets also contain the following ingredients: hydroxypropyl methylcellulosff, magnesium stearate, povidone, and silicon dioxide. Phenylephrine hydrochloride is an orally effective nasal decongestant. Chemically, it is (S)-3-hydroxy-a-[(methylamino) 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 children 12 years of age and older: 1 tablet every 12 hours. Children 6 to under 12 years of age: 1/2 tablet every 12 hours, not to exceed 1 tablet in 24 hours. Tablets may be broken in half without affecting release of the medication but not crushed or chewed."],"drug_abuse_and_dependence":["DRUG ABUSE AND DEPENDENCE Central nervous system stimulants have been abused. At high doses, subject commonly experienc an elevation of mood, sense of increased energy and alertness, and decreassed 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 tncreases 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 interferes with the colorimetric determination of 5-hydroxyindoleacetic acid (5HIM) 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":["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 interferes with the colorimetric determination of 5-hydroxyindoleacetic acid (5HIM) 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."],"effective_time":"20110318","general_precautions":["General DO NOT CRUSH OR CHEW PHENYLEPHRINE HYDROCHLORIDE AND GUAIFENESIN TABLETS BEFORE INGESTION TO PRESERVE THE LONG-ACTING EFFECT."],"geriatric_use":["Geriatric Use Patients aged 60 and older 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. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range. reflecting the greater frequency of decreased hepatic, renal or cardiac function, and of concomitant disease or drug therapy."],"how_supplied":["HOW SUPPLIED Phenylephrine Hydrochloride and Guaitenesin Tablets are supplied as a white, scored, caplet embossed with \"PRA | SCO\" on one side and \"326\" on the other in bottles of 100. NDC 66993- 326-02. Dispense in a tight, light-resistant container as defined in USP/NF with a child-resistant closure. Store at 20 o to 25 o C (68 o to 77 o F) (See USP Controlled Room Ternperature. WARNING: KEEP THIS AND ALL MEDICATION OUT OF REACH Of CHILDREN. IN CASE OF ACCIDENTAL OVERDOSE, SEEK PROFESSIONAL ASSITANCE OR CONTACT A POISON CENTER IMMEDIATELY."],"id":"b5f8741b-cb52-4889-bd94-07d18d660fab","indications_and_usage":["INDICATIONS AND USAGE Phenylephrine Hydrochloride and Guaifenesin Tablets are indicated for the relief of nasal congestion due to the common cold, hay fever or other upper respiratory allergies and nasal congestion associated with sinusitis. To promote nasal or sinus drainage; for the relief of eustachian tube congestion; for adjunctive therapy in serous otitis media; for the symptomatic relief of respiratory conditions characterized by dry, nonproductive cough and in the presence of tenacious mucous and/or mucous plugs in the respiratory tract."],"information_for_patients":["Information for Patients As with other sympathomimetic drugs, Phenylephrine Hydrochloride and Guaifenesin Tablels should be used with caution in the presence of hypertension, hyperthyroidism, diabetes-, heart disease, peripheral vascular disease, glaucoma and prostatic hypertrophy."],"labor_and_delivery":["Labor and Delivery"],"laboratory_tests":["Laboratory Tests"],"nonteratogenic_effects":["Nonteratogenic Effects"],"nursing_mothers":["Nursing Mothers Small amounts of phenylephrine are excre1ed in mast milk. Use of this product by nursing mothers is not recommended because of the higher than usual risk for infants from sympathomimetic amines. It is not known if guaifenesin is excreted in human milk."],"openfda":{},"overdosage":["OVERDOSAGE Since the effects of Phenylehrine Hydrochloride and Guaifenesin Tablets may last up to 12 hours, treatment of overdosage directed towards supporting the patient and reversing the effects of the drug should be continued for at least that length of time. Saline cathartics may be useful in hastening the evacuation of unreleased medication. Sign. and symptoms: 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. 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. Treatment: Treatment of acute overdosage should 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 ipepac syrup unless the patient is convulslng. comatose or has lost the gag refIex, in which case perform gastric lavage using a large bore tube. If indicated. follow with activated charcoal and saline cathartic"],"package_label_principal_display_panel":["PACKAGE/LABEL PRINCIPAL DISPLAY PANEL CONTAINER LABEL 6977 CL"],"pediatric_use":["Pediatric Use Safely and effectiveness of this product in pediatric patients below the age of 6 years have not been established. This product contains a fixed dose of phenylephrine hydrochloride in an extended release formulation. 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 sympath· omimetic 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."],"precautions":["PRECAUTIONS General DO NOT CRUSH OR CHEW PHENYLEPHRINE HYDROCHLORIDE AND GUAIFENESIN TABLETS BEFORE INGESTION TO PRESERVE THE LONG-ACTING EFFECT. Information for Patients As with other sympathomimetic drugs, Phenylephrine Hydrochloride and Guaifenesin Tablels should be used with caution in the presence of hypertension, hyperthyroidism, diabetes-, heart disease, peripheral vascular disease, glaucoma and prostatic hypertrophy. 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 interferes with the colorimetric determination of 5-hydroxyindoleacetic acid (5HIM) and vanillylmandelic acid (VMA). Administration of the drug should be discontinued 48 hours prior to the collection of urine specimens for such tests. Carcinogenesis, Mutagenesis, Impairment of Fertility There are no animal or in vitro studies on the combination product phenylephrine hydrochloride and guaifenesin to evaluate carcinogenesis, mutagenesis, and impairment of fertility. 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 the potential benefit justifies risk to the fetus. Teratogenic Effects Nonteratogenic Effects Labor and Delivery Nursing Mothers Small amounts of phenylephrine are excre1ed in mast milk. Use of this product by nursing mothers is not recommended because of the higher than usual risk for infants from sympathomimetic amines. It is not known if guaifenesin is excreted in human milk. Pediatric Use Safely and effectiveness of this product in pediatric patients below the age of 6 years have not been established. This product contains a fixed dose of phenylephrine hydrochloride in an extended release formulation. 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 sympath· omimetic 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. Geriatric Use Patients aged 60 and older 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. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range. reflecting the greater frequency of decreased hepatic, renal or cardiac function, and of concomitant disease or drug therapy."],"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 the potential benefit justifies risk to the fetus. Teratogenic Effects Nonteratogenic Effects"],"set_id":"b5f8741b-cb52-4889-bd94-07d18d660fab","spl_product_data_elements":["PHENYLEPHRINE and GUAIFENESIN PHENYLEPHRINE and GUAIFENESIN GUAIFENESIN GUAIFENESIN PHENYLEPHRINE HYDROCHLORIDE PHENYLEPHRINE POVIDONE K30 HYPROMELLOSE 2208 (15000 MPA.S) SILICON DIOXIDE MAGNESIUM STEARATE PRA;SCO"],"teratogenic_effects":["Teratogenic Effects"],"version":"1","warnings":["WARNINGS"]}