{"abuse":["Abuse"],"adverse_reactions":["ADVERSE REACTIONS Gastrointestinal: nausea and vomiting. Cenetral Nervous System: nervousness, dizziness, sleeplessness, lightheadedness, tremor, hallucin-ations, convulsions, CNS depression, fear, anxiety, headache, increased irritability or excitement. Cardiovascular: palpitations, tachycardia, cardiovascular collapse and death. General: weakness. Respiratory: respiratory difficulties."],"carcinogenesis_and_mutagenesis_and_impairment_of_fertility":["Carcinogenesis, Mutagenesis, Impairment of Fertility"],"clinical_pharmacology":["CLINICAL PHARMACOLOGY Phenylephrine hydrochloride is an a-adrenergic receptor agonist (sympathomimetic) which produces vasoconstriction by stimulating a-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, insipissated 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 Sinuvent PE tablets are contraindicated in patients with a known hyper-sensitivity to any of its ingredients, in nursing mothers, or in patients with severe hypertension, severe coronary artery disease, prostatic hypertrophy, or in patients on MAO inhibitor therapy."],"controlled_substance":["Controlled Substance"],"dependence":["Dependence"],"description":["DESCRIPTION Each Sinuvent PE Tablet Contains: Phenylephrine HCI........................... 15mg Guaifenesin...................................... 600 mg Chemically, phenylephrine hydrochloride is a decongestant having the chemical name, benzenemethanol, 3-hydroxy-a-[(methylamino)methylj-, hydrochloride. Guaifenesin is an expectorant having the chemical name, 1,2-propanediol, 3-(2-methoxyphenoxy)"],"dosage_and_administration":["DOSAGE AND ADMINISTRATION Adults and adolescents 12 years of age and older: Two tablets twice daily (every 12 hours). Children 6 to 12 years: One tablet twice daily (every 12 hours). Children under6 years ofage: As recommended by a physician. Tablets may be broken in half for ease of administration. Geriatirc patients maybe 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 has been reported to interfere with clinical lab-oratory determinations of urinary 5-hydroxyindoleacetic acid (S-HIAA) and urinary vanillylmandelic acid (VMA)."],"drug_interactions":["Interactions Drug Interactions Monoamine oxidase (MAO) inhibitors and beta-adrenergic blockers increase the effects of sympathomimetic amines. Sympathomimetic amines may reduce the antihypertensive effects of methyldopa, guanethidine, mecamylamine, resperine and veratrum alkaloids. Drug/Laboratory Test Interactions Guaifenesin has been reported to interfere with clinical lab-oratory determinations of urinary 5-hydroxyindoleacetic acid (S-HIAA) and urinary vanillylmandelic acid (VMA).","Drug Interactions Monoamine oxidase (MAO) inhibitors and beta-adrenergic blockers increase the effects of sympathomimetic amines. Sympathomimetic amines may reduce the antihypertensive effects of methyldopa, guanethidine, mecamylamine, resperine and veratrum alkaloids."],"effective_time":"20110323","general_precautions":["General Hypertensive patients should use Sinuvent 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 sympathomimetics. Overdose may cause hallucinations, convulsions, CNS depression and death. Demonstrate safe use of a short-acting sympathomimeticbeforeuse of a sustained action formulation in elderly patients."],"how_supplied":["HOW SUPPLIED Sinuvent PE tablets are available as light green, scored, capsule-shaped tablets with the logo\"WE\" scored \"35~plain bottom. In bottles of 100. NDC 59196-035-01. Sample boxes of 8. NDC 59196-035-02. KEEP THIS AND ALL MEDICATION OUT OF THE REACH OF CHILDREN. IN CASE OF ACCIDENTAL OVER-DOSE, SEEK PROFESSIONAL ASSISTANCE OR CONTACT A POISON CONTROL CENTER IMMEDIATELY. Dispense in a tight, light-resistant container as defined in the USP/NF. Store at 15° -30° C (59° -86° F)."],"id":"0bfb8e68-5a65-4994-bbf0-d3d926371ce9","indications_and_usage":["INDICATIONS AND USAGE Sinuvent 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 Sinuvent PE tablets are contraindicated in the nursing mother because of the higher than usual risks to infants from sympathomimetic agents."],"openfda":{},"overdosage":["OVERDOSAGE Symptons: Overdosage may cause hallucinations, convulsions, CNS 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 a saline cathartic. Since the effects of Sinuvent 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 6450 CL"],"pediatric_use":["Pediatric Use Safety and effectiveness of Sinuvent PE tablets in pediatric patients below the age of 6 have not been established."],"precautions":["PRECAUTIONS General Hypertensive patients should use Sinuvent 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 Monoamine oxidase (MAO) inhibitors and beta-adrenergic blockers increase the effects of sympathomimetic amines. Sympathomimetic amines may reduce the antihypertensive effects of methyldopa, guanethidine, mecamylamine, resperine and veratrum alkaloids. Drug/Laboratory Test Interactions Guaifenesin has been reported to interfere with clinical lab-oratory determinations of urinary 5-hydroxyindoleacetic acid (S-HIAA) and urinary vanillylmandelic acid (VMA). Carcinogenesis, Mutagenesis, Impairment of Fertility Pregnancy Category C: Animal reproduction studies have not been conducted with Sinuvent PE tablets. It is also not known whether Sinuvent PE tablets can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Sinuvent PE tablets should be given to a pregnant woman only if clearly needed. Teratogenic Effects Nonteratogenic Effects Labor and Delivery Nursing Mothers Sinuvent 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 Sinuvent 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 sympathomimetics. Overdose may cause hallucinations, convulsions, CNS depression and death. Demonstrate safe use of a short-acting sympathomimeticbeforeuse of a sustained action formulation in elderly patients."],"pregnancy":["Pregnancy Category C: Animal reproduction studies have not been conducted with Sinuvent PE tablets. It is also not known whether Sinuvent PE tablets can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Sinuvent PE tablets should be given to a pregnant woman only if clearly needed. Teratogenic Effects Nonteratogenic Effects"],"set_id":"0bfb8e68-5a65-4994-bbf0-d3d926371ce9","spl_product_data_elements":["SINUVENT PE PHENYLEPHRINE and GUAIFENESIN GUAIFENESIN GUAIFENESIN PHENYLEPHRINE HYDROCHLORIDE PHENYLEPHRINE CROSPOVIDONE FD&C BLUE NO. 1 D&C YELLOW NO. 10 SILICON DIOXIDE HYPROMELLOSE 2910 (5 MPA.S) MAGNESIUM STEARATE WE;35"],"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, hyper-thyroidism, or prostatic hypertrophy."]}