{"active_ingredient":["Active ingredients (in each 5 mL, 1 teaspoon) Dextromethorphan HBr, 20 mg Guaifenesin, 400 mg"],"dosage_and_administration":["​ Directions • do not take more than 6 doses in any 24-hour period. • mL = milliliter age dose Adults and children 12 years of age and over 1 teaspoon (5 mL) every 4 hours Children under 12 years of age do not use"],"dosage_and_administration_table":["<table width=\"70%\"><tbody><tr><td styleCode=\"Botrule Lrule Rrule Toprule\" align=\"center\"> age </td><td styleCode=\"Botrule Lrule Rrule Toprule\" align=\"center\"> dose</td></tr><tr><td styleCode=\"Botrule Lrule Rrule Toprule\" align=\"center\"> Adults and children 12 years of age and over</td><td styleCode=\"Botrule Lrule Rrule Toprule\" align=\"center\"> 1 teaspoon (5 mL) every 4 hours</td></tr><tr><td styleCode=\"Botrule Lrule Rrule Toprule\" align=\"center\"> Children under 12 years of age</td><td styleCode=\"Botrule Lrule Rrule Toprule\" align=\"center\"> do not use</td></tr></tbody></table>"],"effective_time":"20251114","id":"a7c507ab-f326-4890-b26d-d80c59cacf8a","inactive_ingredient":["Inactive ingredients citric acid, eucalyptus oil, flavors, glycerin, menthol, methylparaben, propylene glycol, propylparaben, purified water, sodium citrate, sucralose"],"indications_and_usage":["Uses • temporarily relieves cough due to minor throat and bronchial irritation as may occur with a cold • helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes"],"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":{"application_number":["M012"],"brand_name":["G-ZYNCOF"],"generic_name":["DEXTROMETHORPHAN HBR AND GUAIFENESIN"],"is_original_packager":[true],"manufacturer_name":["Kramer Novis"],"nui":["N0000193956","N0000008867","N0000009560"],"package_ndc":["52083-600-16"],"pharm_class_epc":["Expectorant [EPC]"],"pharm_class_pe":["Decreased Respiratory Secretion Viscosity [PE]","Increased Respiratory Secretions [PE]"],"product_ndc":["52083-600"],"product_type":["HUMAN OTC DRUG"],"route":["ORAL"],"rxcui":["1113368"],"spl_id":["a7c507ab-f326-4890-b26d-d80c59cacf8a"],"spl_set_id":["c1aa7060-0f32-4ea1-8e2e-1aa131bd55fc"],"substance_name":["DEXTROMETHORPHAN HYDROBROMIDE","GUAIFENESIN"],"unii":["9D2RTI9KYH","495W7451VQ"],"upc":["0352083600166"]},"package_label_principal_display_panel":["Packaging G-ZYNCOF"],"purpose":["Purposes Cough suppressant Expectorant"],"questions":["Questions or comments? 1-787-767-2072 You may also report serious side effects to this phone number. Call weekdays from 8AM to 4PM AST"],"recent_major_changes":["Directions: (The following changes were made) • mL=milliliter • A table was included with the dosage instructions according to age: age dose Adults and children 12 years of age and over 1 teaspoon (5 mL) every 4 hours Children under 12 years of age do not use"],"recent_major_changes_table":["<table width=\"80%\"><caption/><tbody><tr><td styleCode=\"Lrule Rrule Toprule Botrule\">age</td><td styleCode=\"Lrule Rrule Toprule Botrule\">dose</td></tr><tr><td styleCode=\"Lrule Rrule Toprule Botrule\">Adults and children 12 years of age and over</td><td styleCode=\"Lrule Rrule Toprule Botrule\">1 teaspoon (5 mL) every 4 hours</td></tr><tr><td styleCode=\"Lrule Rrule Toprule Botrule\">Children under 12 years of age</td><td styleCode=\"Lrule Rrule Toprule Botrule\">do not use</td></tr></tbody></table>"],"set_id":"c1aa7060-0f32-4ea1-8e2e-1aa131bd55fc","spl_product_data_elements":["G-ZYNCOF Dextromethorphan HBr and Guaifenesin DEXTROMETHORPHAN HYDROBROMIDE DEXTROMETHORPHAN GUAIFENESIN GUAIFENESIN CITRIC ACID MONOHYDRATE EUCALYPTUS OIL GLYCERIN MENTHOL, UNSPECIFIED FORM METHYLPARABEN PROPYLENE GLYCOL PROPYLPARABEN WATER SODIUM CITRATE, UNSPECIFIED FORM SUCRALOSE GRAPE"],"spl_unclassified_section":["Drug Facts","Dextromethorphan HBr COUGH SUPPRESSANT Guaifenesin EXPECTORANT SUGAR FREE & ALCOHOL FREE NO DYE - NO SACCHARIN - NO ASPARTAME KramerNovis Pharmaceuticals within reach of patients Manufactured in USA with imported ingredients for Kramer Novis, San Juan, PR 00917 www.kramernovis.com"],"storage_and_handling":["Other information • Tamper evident feature: Do not use if printed security seal is torn, broken or missing • Store at controlled room temperature 15-30°C (59-86°F) • Avoid excessive heat or humidity."],"version":"5","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 • cough that occurs with too much phlegm (mucus) • cough that lasts or is chronic such as occurs with smoking, asthma, chronic bronchitis, or emphysema. When using this product, do not use more than directed. Stop use and ask a doctor if cough lasts more than 7 days, comes back, or is accompanied by fever, rash, or persistent headache. These could be signs of a serious condition. If pregnant or breast-feeding , ask a health professional before use. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away."]}