{"abuse":["Abuse"],"adverse_reactions":["ADVERSE REACTIONS Sympathomimetics have been associated with certain untoward reactions including fear, anxiety, nervousness, restlessness, tremor, weakness, pallor, respiratory difficulty, dysuria, tachycardia, palpitations, headache, dizziness, nausea, insomnia, hallucinations, convulsions, CNS depression arrhythmias, and cardiovascular collapse with hypotension. Guaifenesin may cause nausea. vomiting, diarrhea, and gastric irritation."],"carcinogenesis_and_mutagenesis_and_impairment_of_fertility":["Carcinogenesis, Mutagenesis, Impairment of Fertility"],"clinical_pharmacology":["CLINICAL PHARMACOLOGY Phenylephrine hydrochloride is an α-adrenergic receptor agonist (Sympathomimetic) which produces vasoconstriction by stimulating \",·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 patency. 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 of these drugs, sinus and bronchial drainage is improved, and dry, nonproductive coughs become more productive and less frequent."],"contraindications":["CONTRAINDICATIONS RESPA ® PE tablets are contraindicated in 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, ventricular tachycardia or in patients on MAO inhibitor therapy."],"controlled_substance":["Controlled Substance"],"dependence":["Dependence"],"description":["DESCRIPTION"],"dosage_and_administration":["DOSAGE AND ADMINISTRATION Adults and children 12 years of age and older: Two tablets twice daily (every 12 hours). Children 5 to 12 years: One tablet twice daily (every 12 hours). Not recommended tor 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 may increase renal clearance for urate and thereby lower serum uric acid levels. Guaifenesin has been reported to interfere with clinical laboratory determinations of urinary 5-hydroxy-indoteacetic acid (S-HIAA) and urinary vanillylmandelic acid (VMA)."],"drug_interactions":["Interactions Drug Interactions Do not prescribe this product for use in patients taking a prescription MAOI (certain drugs for depression, psychiatric or emotional conditions, or Parkinson's disease), or for 14 days after stopping the MAOI drug therapy. Monoamine oxidase (MAO) inhibitors and beta-adrenergic blockers increase the effects of Sympathomimetic amines. Sympathomimetic amines may reduce the antihypertensive effects of methyldopa, guanethidine, mecamyiamine, reserpine and veratrum alkaloids. Drug/Laboratory Test Interactions Guaifenesin may increase renal clearance for urate and thereby lower serum uric acid levels. Guaifenesin has been reported to interfere with clinical laboratory determinations of urinary 5-hydroxy-indoteacetic acid (S-HIAA) and urinary vanillylmandelic acid (VMA).","Drug Interactions Do not prescribe this product for use in patients taking a prescription MAOI (certain drugs for depression, psychiatric or emotional conditions, or Parkinson's disease), or for 14 days after stopping the MAOI drug therapy. Monoamine oxidase (MAO) inhibitors and beta-adrenergic blockers increase the effects of Sympathomimetic amines. Sympathomimetic amines may reduce the antihypertensive effects of methyldopa, guanethidine, mecamyiamine, reserpine and veratrum alkaloids."],"effective_time":"20110322","general_precautions":["General Hypertensive patients should use RESPA ® ·PE tablets 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 Sympathomimetic. 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 RESPA ® PE tablets are available as white, scored, capsule-shaped tablets debossed with \"RESPA 787\" and blank on the scored side. In bottles of 100. NDC 60575-787-19. KEEP THIS AND ALL MEDICATION OUT OF REACH OF CHILDREN. IN CASE OF ACCIDENTAL OVERDOSE, SEEK PROFESSIONAL ASSISTANCE OR CONTACT A POISON CONTROL CENTER IMMEDIATELY. Dispense in a tight, light-restraint container as defined in the USP/NF. Store at controlled room temperature between 20°- 25°C (68° - 77°F)."],"id":"a6d61b83-cfd8-42b0-8920-c6dceae06436","indications_and_usage":["INDICATIONS AND USAGE RESPA ® ·PE Is 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 symptomatic relief of respiratory conditions characterized by dry nonproductive cough and in the presence of tenacious mucus and/or mucous plugs in the respiratory tract."],"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 RESPA ® PE tablets are 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, eNS depression, cardiovascular collapse and death. 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 large-bore tube. If indicated, follow with activated charcoal and saline cathartic. Since the effects of RESPA ® PE tablets 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 6595 CL"],"pediatric_use":["Pediatric Use Safety and effectiveness of RESPA ® PE tablets in pediatric patients below the age of 6 have not been established."],"precautions":["PRECAUTIONS General Hypertensive patients should use RESPA ® ·PE tablets 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 Do not prescribe this product for use in patients taking a prescription MAOI (certain drugs for depression, psychiatric or emotional conditions, or Parkinson's disease), or for 14 days after stopping the MAOI drug therapy. Monoamine oxidase (MAO) inhibitors and beta-adrenergic blockers increase the effects of Sympathomimetic amines. Sympathomimetic amines may reduce the antihypertensive effects of methyldopa, guanethidine, mecamyiamine, reserpine and veratrum alkaloids. Drug/Laboratory Test Interactions Guaifenesin may increase renal clearance for urate and thereby lower serum uric acid levels. Guaifenesin has been reported to interfere with clinical laboratory determinations of urinary 5-hydroxy-indoteacetic acid (S-HIAA) and urinary vanillylmandelic acid (VMA). Carcinogenesis, Mutagenesis, Impairment of Fertility Pregnancy Category C: Animal reproduction studies have not been conducted with RESPA ® PE lablets. It is also not known whether RESPA ® PE tablets can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. RESPA ® PE tablets should be given to a pregnant woman only If clearly needed. Teratogenic Effects Nonteratogenic Effects Labor and Delivery Nursing Mothers RESPA ® PE tablets are contraindicated in the nursing mother because of the higher than usual risks to infants from Sympathomimetic agents. Pediatric Use Safety and effectiveness of RESPA ® PE tablets in pediatric patients below the age of 6 have not been established. Geriatric Use Patients 60 years and older are more likely to experience adverse reactions to Sympathomimetic. 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 RESPA ® PE lablets. It is also not known whether RESPA ® PE tablets can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. RESPA ® PE tablets should be given to a pregnant woman only If clearly needed. Teratogenic Effects Nonteratogenic Effects"],"set_id":"a6d61b83-cfd8-42b0-8920-c6dceae06436","spl_product_data_elements":["RESPA -PE GUAIFENESIN and PHEHYLEPHRINE GUAIFENESIN GUAIFENESIN PHENYLEPHRINE HYDROCHLORIDE PHENYLEPHRINE CROSPOVIDONE SILICON DIOXIDE HYPROMELLOSE 2910 (5 MPA.S) MAGNESIUM STEARATE RESPA;787"],"spl_unclassified_section":["Each dye·free RESPA ® PE tablet contains: Phenylephrine HCI.................................. 18 mg Gualfenesin............................................ 600 mg In a special base to provide a prolonged therapeutic effort. Chemically. phenylephrine hydrochloride is a decongestant having the chemical name, benzenemethanol, 3-hydroxy-α- [(methylamino)methyl]-, hydrochloride (R). Guaifenesin is an expectorant having the chemical name, 1,2 propanediol, 3-(2-methoxyphenoxy)-, (±)."],"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 intraocular pressure, hyperthyroidism. or prostatic hypertrophy. Sympathomimetic amines may produce CNS stimulation and convulsions or cardiovascular collapse with accompanying hypotension. Do not exceed recommended dosage. Hypertensive crises can occur with concurrent use of pseudoephedrine or phenylephrine and MAOI, 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"]}