{"abuse":["Abuse"],"adverse_reactions":["ADVERSE REACTIONS Gastrointestinal: nausea and vomiting. Central Nervous System: nervousness, dizziness, sleeplessness, lightheadedness, tremor, hallucinations, 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 α-adrenegic receptor agonist (sympathomimetic) which produces vasoconstriction by stimulating ß-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. Dextromethorphan is an antitussive agent, which, unlike the isomeric levorphanol, has no analgesic or addictive properties. The drug acts centrally and elevates the threshold for coughing. It is about equal to codeine in depressing the cough reflex. In therapeutic dosages, it does not inhibit ciliary activity. Dextromethorphan is rapidly absorbed from the gastrointestinal tract, metabolized by the liver and excreted primarily in the urine."],"contraindications":["CONTRAINDICATIONS Sinutuss TM DM 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, or in patients on MAO inhibitor therapy."],"controlled_substance":["Controlled Substance"],"dependence":["Dependence"],"description":["DESCRIPTION Each Sinutuss TM DM Tablet contains: Phenylephrine HCI ............................. 15mg Guaifenesin ....................................... 600mg Dextromethorphan HBr ..................... 30mg Inactive ingredients: dibasic calcium phosphate, hypromellose, magnesium stearate, silicon dioxide, and stearic acid. Chemically, phenylephrine hydrochloride is a decongestant having the chemical name, benzenemethanol, 3-hydroxy-u-[(methylamino)methyl]-, hydrochloride. Guaifenesin is an expectorant having the chemical name, 1,2-propanediol, 3-(2-methoxyphenoxy. Dextromethorphan hydrobromide is a salt of the methylether of the dextrorotatory isomer of levorphanol, a narcotic analgesic, and is an antitussive having the chemical name: morphinan,3-methoxy-17methyl-, (9α, 13α, 14α)-, hydrobromide."],"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 under 6 years of age: As recommended by a physician. 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 exceed recommended dosage. 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 laboratory determinations of urinary S-hydroxyinindoleacetic 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, reserpine and veratrum alkaloids. Do not use if you are now taking a prescription monomine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product. Drug/Laboratory Test Interactions Guaifenesin has been reported to interfere with clinical laboratory determinations of urinary S-hydroxyinindoleacetic 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, reserpine and veratrum alkaloids. Do not use if you are now taking a prescription monomine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product."],"effective_time":"20110322","general_precautions":["General Hypertensive patients should use Sinutuss'\" DM 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."],"how_supplied":["HOW SUPPLIED Sinutuss TM DM tablets are available as dye-free, scored, capsule-shaped tablets with the letters \"WE\" scored \"4S'; plain bottom. In bottles of 100 (NDC 59196-045-01). Samples boxes of 8 (NDC 59196-045-02). KEEP THIS AND ALL MEDICATION OUT OF THE REACK OF CHtLOREN. IN CASE OF ACCIDENTAL OVERDOSE, 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":"ceac445d-d6aa-4ab1-b05d-c16763715eef","indications_and_usage":["INDICATIONS AND USAGE Sinutuss TM DM 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 Persistentcoughmayindicateaseriouscondition. Ifcoughpersistsformorethanone 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 Sinutuss TM DM 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, CNS depression, cardiovascular collapse and death. Overdosage with dextromethorphan HBr may produce nausea and vomiting, central nervous system excitement and mental confusion, visual disturbances, and urinary retention. Very high doses may produce respiratory depression. One case of toxic psychosis (hyper-reactivity, marked visual and auditory hallucinations) after a single 300 mg dose of dextromethorphan has been reported. 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 carthartic. Since the effects of Sinutuss TM DM 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 Melissa.s@cb-travel.com 6484 CL"],"pediatric_use":["Pediatric Use Safety and effectiveness of Sinutuss TM DM tablets in pediatric patients below the age of 6 have not been established."],"precautions":["PRECAUTIONS General Hypertensive patients should use Sinutuss'\" DM tablets only with medical advice, as they may experience a change in blood pressure due to added vasoconstriction. Information for Patients Persistentcoughmayindicateaseriouscondition. Ifcoughpersistsformorethanone 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, reserpine and veratrum alkaloids. Do not use if you are now taking a prescription monomine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product. Drug/Laboratory Test Interactions Guaifenesin has been reported to interfere with clinical laboratory determinations of urinary S-hydroxyinindoleacetic acid (S-HIAA) and urinary vanillylmandelic acid (VMA). Carcinogenesis, Mutagenesis, Impairment of Fertility Pregnancy Category C: Animal reproduction studies have not been conducted with Sinutuss TM DM tablets. It is also not known whether Sinutuss TM DM tablets can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Sinutuss TM DM tablets should be given to a pregnant woman only if clearly needed. Teratogenic Effects Nonteratogenic Effects Labor and Delivery Nursing Mothers Sinutuss TM DM 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 Sinutuss TM DM 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."],"pregnancy":["Pregnancy Category C: Animal reproduction studies have not been conducted with Sinutuss TM DM tablets. It is also not known whether Sinutuss TM DM tablets can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Sinutuss TM DM tablets should be given to a pregnant woman only if clearly needed. Teratogenic Effects Nonteratogenic Effects"],"set_id":"ceac445d-d6aa-4ab1-b05d-c16763715eef","spl_product_data_elements":["SINU-TUSS PHENYLEPHRINE, GUAIFENESIN, and DEXTROMETHORPHAN GUAIFENESIN GUAIFENESIN PHENYLEPHRINE HYDROCHLORIDE PHENYLEPHRINE DEXTROMETHORPHAN HYDROBROMIDE DEXTROMETHORPHAN HYPROMELLOSE 2910 (15000 MPA.S) HYPROMELLOSE 2910 (5 MPA.S) DIBASIC CALCIUM PHOSPHATE DIHYDRATE SILICON DIOXIDE STEARIC ACID MAGNESIUM STEARATE WE;45"],"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. Do not exceed recommended dosage. If nervousness, dizziness, or sleeplessness occur, discontinue use and consult a doctor. If symptoms do not improve within 7 days or are accompanied by fever, consult a doctor. Do not take this product if you have heart disease, high blood pressure, thyroid disease, diabetes, or difficulty in urination due to enlargement ofthe prostate gland unless directed by a doctor."]}