{"abuse":["Abuse"],"adverse_reactions":["ADVERSE REACTIONS Hyper-reactive 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, arrhyhmias, and cardiovascular collapse with hypotension. No serious side effects have been reported with the use of guaifenesin."],"carcinogenesis_and_mutagenesis_and_impairment_of_fertility":["Carcinogenesis, Mutagenesis, Impairment of Fertility No data are available on the long-term potential of the components of this product for carcinogenesis, mutagenesis, or impairment of fertility in animals or humans."],"clinical_pharmacology":["CLINICAL PHARMACOLOGY Pseudoephedrine hydrochloride is an orally active sympathomimetic amine and exerts a decongestant action on the nasal mucosa. It does this by vasoconstriction which results in reduction of tissue hyperemia, edema, nasal congestion, and an increase in nasal airway patency. The vasoconstrictive action of pseudoephedrine is similar to that of ephedrine. In the usual dose it has minimal vasopressor effects. Pseudoephedrine is rapidly and almost completely absorbed from the gastrointestinal tract. It has a plasma half-life of 6 to 8 hours. Acidic urine is associated with faster elimination of the drug. The drug is distributed to body tissues and fluids, including the fetal tissue, breast milk and the central nervous system (CNS). Approximately 50% to 75% of the administered dose is excreted unchanged in the urine; the remainder is apparently metabolized in the liver to inactive compounds by N-dernethylation, parahydroxylation and oxidative deamination. 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 ciliary action in removing acculumulated 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 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. Sympathomimetic amines are contraindicated in patients with severe hypertension, severe coronary artery diseases, severe convulsions or cardiovascular collapse with accompanying hypotension and patients currently on monoamine oxidase inhibitor (MAOI) therapy and for 14 days after stopping MAOI therapy."],"controlled_substance":["Controlled Substance"],"dependence":["Dependence"],"description":["DESCRIPTION Each scored, white, dye-free Respa-1st tablet provides 58 mg pseudoephedrine hydrochloride and 600 mg guaifenesin in a sustained-release formulation intended for oral adminis1ration. Inactive ingredients: Partially hydrogenated cottonseed oil, hydroxypropyl methylcellulose, stearic acid, magnesium stearate and silicon dioxide. Pseudoephedrine hydrochloride is a nasal decongestant. Chemically, it is benzenemethanol, α [1-methylamino)ethyl]-,[S-(R*,R*)]-, hydrochloride. Guaifenesin is an expectorant. Chemically, it is 3-(2-methoxyphenoxy)-1, 2-propanedol."],"dosage_and_administration":["DOSAGE AND ADMINISTRATION Adults and children over 12 years of age: One or two tablets every 12 hours not to exceed 4 tablets in 24 hours. Children 6 to 12 years: 1 tablet every 12 hours not to exceed 2 tablets in 24 hours. Not recommended for children under 6 years of age."],"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 may produce an increase in urinary 5-hydroxy-indoleacetic 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 this drug should be discontinued 48 hours prior to the collection of urine specimens for such test."],"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. Beta-adrenergic blockers and MAO inhibitors may potentiate the pressor effect of pseudoephedrine. 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 pseudoephedrine. 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-hydroxy-indoleacetic 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 this drug should be discontinued 48 hours prior to the collection of urine specimens for such test.","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. Beta-adrenergic blockers and MAO inhibitors may potentiate the pressor effect of pseudoephedrine. 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 pseudoephedrine."],"effective_time":"20110322","general_precautions":["General Use with caution in patients with diabetes, hypertension, cardiovascular disease and hyper-reactivity to ephedrine. Before prescribing medication to suppress of modify cough, it is important to ascertain that the underlying cause of cough is ldentified, that modification of cough does not increase the risk of clinical or physiologic complications, and that appropriate therapy for the primary disease is instituted."],"geriatric_use":["Geriatric Use The elderly (60 years 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."],"how_supplied":["HOW SUPPLIED Bottles of 100 tablets (NDC 60575-08719). Scored, white, dye-free uncoated tablets are embossed with \"RESPA 087\". Store at controlled room temperature between 20° -25°C (68° - 77°F). Dispense in tight, light-resistant containers with a child-resistant closure."],"id":"ed91386c-1fa7-4121-9ab9-051e66baf9ac","indications_and_usage":["INDICATIONS AND USAGE RESPA-1st Tablets are indicated for the temporary relief of nasal congestion and cough associated with respiratory tract infections and related conditions such as sinusitis, pharyngitis, bronchitis, and asthma, when these conditions are complicated by tenacious mucus plugs and congestion. The product is effective in productive as well as non-productive cough but is of particular value in dry, non-productive cough which tends to injure the mucous membrane of the aier passages."],"information_for_patients":["Information for Patients Do not crush or chew this product prior to swallowing. Patients should be instructed to cheek with physician if symptoms do not improve within 5 days or if fever is present."],"labor_and_delivery":["Labor and Delivery"],"laboratory_tests":["Laboratory Tests"],"nonteratogenic_effects":["Nonteratogenic Effects"],"nursing_mothers":["Nursing Mothers Pseudoephedrine is excreted in breast milk. Use of this product by nursing mothers is not recommended because of the higher than usual risk to infants from sympathomimetic amines."],"openfda":{},"overdosage":["OVERDOSAGE Since Respa-1st Tablets contain two pharmacologically different compounds, treatment of overdosage should be based upon the symptomatology of the patient as it relates to the individual ingredients. Treatment of acute overdosage would probably be based upon treating the patient for pseudoephedrine toxicity which may manifest itself as excessive CNS stimulation resulting in excitement, tremor, restlessness and insomnia. Other effects may include tachycardia, hypertension, pallor, mydriasis, hyperglycemia, and urinary retention. Severe overdosage may cause tachypnea or hyperpnea, hallucinations, convulsions, or delirium, but in some individuals there may be CNS depression with somnolence, stupor or respiratory depression. Arrhythmia (including ventricular fibrillation) may lead to hypotension and circulatory collapse. Severe hypokalemia can occur, probably due to a compartmental shift rather than a depletion of potassium. No organ damage or significant metabolic derangement is associated with pseudoephedrine overdosage. Overdosage with guaifenesin is unlikely to produce toxic effects since its toxicity is much lower than that of pseudoephedrine. The LD50 of pseudoephedrine (single oral dose) has been reported to be 726 mg/kg in the mouse, 2206 mglkg in the rat and 1177 mg/kg in the rabbit. The toxic and lethal concentrations in human biologic fluids are not known. Urinary excretion increases with acidification and decreases with alkalinization of the urine. There are few published reports of toxicity due to pseudoephedrine and no case of fatal overdosage has been reported. Guaifenesin, when administered by stomach tube to test animals in doses up to 5 grams/kg, produced no signs of toxicity. Since the action of sustained release products may continue for as long as 12 hours, treatment of overdosage should be directed toward reducing further absorption and supporting the patient for at least that length of time. Gastric emptying (Syrup of Ipecac) and/or lavage is recommended as soon as possible after ingestion, even if the patient has vomited spontaneously. Either isotonic or half-isotonic saline may be used for lavage. Administration of an activated charcoal slurry is beneficial after lavage and/or emesis if less than 4 hours have passed since ingestion. Saline cathartics, such as Milk of Magnesia, are useful for hastening the evacuation of unreleased medication. Adrenergic receptor blocking agents are antidotes to pseudoephedrine. In practice, the most useful is the betablocker propranolol which is indicated when there are signs of cardiac toxicity. Theoretically, pseudoephedrine is dialyzable but procedures have not been clinically established."],"package_label_principal_display_panel":["PACKAGE/LABEL PRINCIPAL DISPLAY PANEL CONTAINER LABEL 6487 CL"],"pediatric_use":["Pediatric Use This product is not recommended for use in children under 6 years of age."],"precautions":["PRECAUTIONS General Use with caution in patients with diabetes, hypertension, cardiovascular disease and hyper-reactivity to ephedrine. Before prescribing medication to suppress of modify cough, it is important to ascertain that the underlying cause of cough is ldentified, that modification of cough does not increase the risk of clinical or physiologic complications, and that appropriate therapy for the primary disease is instituted. Information for Patients Do not crush or chew this product prior to swallowing. Patients should be instructed to cheek with physician if symptoms do not improve within 5 days or if fever is present. 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. Beta-adrenergic blockers and MAO inhibitors may potentiate the pressor effect of pseudoephedrine. 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 pseudoephedrine. 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-hydroxy-indoleacetic 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 this drug should be discontinued 48 hours prior to the collection of urine specimens for such test. Carcinogenesis, Mutagenesis, Impairment of Fertility No data are available on the long-term potential of the components of this product for carcinogenesis, mutagenesis, or impairment of fertility in animals or humans. Pregnancy Category C: Animal reproduction studies have not been conducted with the components of this product. It is also not known whether these drugs can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Accordingly, this product should be given to a pregnant woman only if clearly needed. Teratogenic Effects Nonteratogenic Effects Labor and Delivery Nursing Mothers Pseudoephedrine is excreted in breast milk. Use of this product by nursing mothers is not recommended because of the higher than usual risk to infants from sympathomimetic amines. Pediatric Use This product is not recommended for use in children under 6 years of age. Geriatric Use The elderly (60 years 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."],"pregnancy":["Pregnancy Category C: Animal reproduction studies have not been conducted with the components of this product. It is also not known whether these drugs can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Accordingly, this product should be given to a pregnant woman only if clearly needed. Teratogenic Effects Nonteratogenic Effects"],"set_id":"ed91386c-1fa7-4121-9ab9-051e66baf9ac","spl_product_data_elements":["RESPA 1st PSEUDOEPHEDRINE and GUAIFENESIN GUAIFENESIN GUAIFENESIN PSEUDOEPHEDRINE HYDROCHLORIDE PSEUDOEPHEDRINE HYDROGENATED COTTONSEED OIL HYPROMELLOSE 2208 (100 MPA.S) MAGNESIUM STEARATE SILICON DIOXIDE STEARIC ACID RESPA;087"],"teratogenic_effects":["Teratogenic Effects"],"version":"1","warnings":["WARNINGS Sympathommetic amines should be used with caution in patients with hypertension, diabetes mellitus, ischemic 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."]}