{"active_ingredient":["Active ingredients (in each tablet) Dextromethorphan HBr 10 mg Guaifenesin 200 mg Pseudoephedrine HCl, 30 mg"],"dosage_and_administration":["Directions Do not exceed recommended dosage. Adults and children 12 years of age and over 2 tablets every 4 hours, not to exceed 8 tablets in 24 hours or as directed by a doctor Children 6 to under 12 years of age 1 tablets every 4 hours, not to exceed 4 tablets in 24 hours or as directed by a doctor Children 2 under 6 years of age ½ tablets every 4 hours, not to exceed 2 tablets in 24 hours or as directed by a doctor Children under 2 years of age Consult physician"],"dosage_and_administration_table":["<table width=\"50%\"><caption/><tbody><tr><td styleCode=\"Botrule Rrule\"><paragraph>Adults and children</paragraph><paragraph>12 years of age and over</paragraph></td><td styleCode=\"Botrule Lrule\"><paragraph> 2 tablets every 4 hours,</paragraph><paragraph> not to exceed 8 tablets</paragraph><paragraph> in 24 hours or as</paragraph><paragraph> directed by a doctor</paragraph></td></tr><tr><td styleCode=\"Botrule Rrule\"><paragraph> Children 6 to under</paragraph><paragraph> 12 years of age</paragraph></td><td styleCode=\"Botrule Lrule\"><paragraph> 1 tablets every 4 hours,</paragraph><paragraph> not to exceed 4 tablets</paragraph><paragraph> in 24 hours or as</paragraph><paragraph> directed by a doctor</paragraph></td></tr><tr><td styleCode=\"Botrule Rrule\"><paragraph>Children 2 under 6 years</paragraph><paragraph>of age</paragraph></td><td styleCode=\"Botrule Lrule\"><paragraph> &#xBD; tablets every 4 hours,</paragraph><paragraph> not to exceed 2 tablets</paragraph><paragraph> in 24 hours or as</paragraph><paragraph> directed by a doctor</paragraph></td></tr><tr><td styleCode=\"Botrule Rrule\"><paragraph>Children under 2</paragraph><paragraph>years of age</paragraph></td><td styleCode=\"Botrule Lrule\"> Consult physician</td></tr></tbody></table>"],"effective_time":"20240104","id":"f5bc8478-e93d-4d5b-b744-5b0c49843d35","inactive_ingredient":["Inactive ingredients: Magnesium Stearate, microcrystalline cellulose, sodium starch glycolate"],"indications_and_usage":["Uses • temporarily relieves cough due to minor throat and bronchial irritation occurring with a cold or inhaled irritants • helps loosen phlegm and thin bronchial secretions to make coughs more productive • temporarily relieves nasal congestion"],"keep_out_of_reach_of_children":["Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away."],"openfda":{},"package_label_principal_display_panel":["Packaging ds 1"],"purpose":["Purpose Antitussive Expectorant Nasal Decongestant"],"set_id":"74a2937d-12d5-4c0b-b237-074b4d7c30b1","spl_product_data_elements":["DESGEN DM Tabs DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PSEUDOEPHEDRINE HYDROCHLORIDE DEXTROMETHORPHAN HYDROBROMIDE DEXTROMETHORPHAN GUAIFENESIN GUAIFENESIN PSEUDOEPHEDRINE HYDROCHLORIDE PSEUDOEPHEDRINE MAGNESIUM STEARATE MICROCRYSTALLINE CELLULOSE SODIUM STARCH GLYCOLATE TYPE A POTATO KN648"],"spl_unclassified_section":["Drug Facts","New Formulation Contains the same active ingredients as Despec ® DM Tablets* • ANTITUSSIVE • EXPECTORANT • NASAL DECONGESTANT Manufactured in the USA for Kramer Novis. San Juan, PR 00917. www.kramernovis.com / (787) 767-2072 * Despec ® DM Tablets is a registered trademark of International Ethical Laboratories. This product is not manufactured, distributed or marketed by International Ethical Laboratories."],"storage_and_handling":["Other information Store at room temperature 59°-86°F (15°-30°C) [see USP Controlled Room Temperature] Tamper evident by foil seal under cap. Do not use if foil seal is broken or missing"],"storage_and_handling_table":["<table width=\"70%\"><caption/><tbody><tr><td styleCode=\"Botrule\"><content styleCode=\"bold\"><content styleCode=\"italics\">Other information</content></content> <list listType=\"unordered\"><item>Store at room temperature 59&#xB0;-86&#xB0;F (15&#xB0;-30&#xB0;C) [see USP Controlled Room Temperature]</item></list></td></tr><tr><td styleCode=\"Toprule\"><paragraph>Tamper evident by foil seal under cap. Do not use if foil seal is broken or missing</paragraph></td></tr></tbody></table>"],"version":"4","warnings":["Warnings Do not use if you are now taking a prescription monoamine 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. Ask a doctor before use if you have • heart disease • high blood pressure • thyroid disease • diabetes • difficulty in urination due to enlarged prostate gland • persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema • cough accompanied by excessive phlegm (mucus) When using this product • do not exceed recommended dosage Stop use and ask a doctor if • cough persists for more than 1 week, tends to recur, or is accompanied by fever, rash, or persistent headache. A persistent cough may be a sign of a serious condition • symptoms do not improve within 7 days or are accompanied by fever • nervousness, dizziness, or sleeplessness occur If pregnant or breastfeeding ask a health professional before use."]}