{"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":["
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
"],"effective_time":"20251113","id":"7e831d13-64c5-4ee2-a290-d1d93ceec80f","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":["ZYNCOF"],"generic_name":["DEXTROMETHORPHAN HBR AND GUAIFENESIN"],"is_original_packager":[true],"manufacturer_name":["Kramer Novis"],"nui":["N0000193956","N0000008867","N0000009560"],"package_ndc":["52083-400-01","52083-400-04","52083-400-16"],"pharm_class_epc":["Expectorant [EPC]"],"pharm_class_pe":["Decreased Respiratory Secretion Viscosity [PE]","Increased Respiratory Secretions [PE]"],"product_ndc":["52083-400"],"product_type":["HUMAN OTC DRUG"],"route":["ORAL"],"rxcui":["1113368"],"spl_id":["7e831d13-64c5-4ee2-a290-d1d93ceec80f"],"spl_set_id":["cffd6d5f-0cb2-4d38-bdb0-6a21120418cc"],"substance_name":["DEXTROMETHORPHAN HYDROBROMIDE","GUAIFENESIN"],"unii":["9D2RTI9KYH","495W7451VQ"]},"package_label_principal_display_panel":["Packaging 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 (5mL) every 4 hours Children under 12 years of age do not use"],"recent_major_changes_table":["
agedose
Adults and children 12 years of age and over1 teaspoon (5mL) every 4 hours
Children under 12 years of agedo not use
"],"set_id":"cffd6d5f-0cb2-4d38-bdb0-6a21120418cc","spl_product_data_elements":["ZYNCOF Dextromethorphan HBr and Guaifenesin DEXTROMETHORPHAN HYDROBROMIDE DEXTROMETHORPHAN GUAIFENESIN GUAIFENESIN CITRIC ACID MONOHYDRATE EUCALYPTUS OIL GLYCERIN MENTHOL METHYLPARABEN PROPYLENE GLYCOL PROPYLPARABEN WATER SODIUM CITRATE SUCRALOSE GRAPE"],"spl_unclassified_section":["Drug Facts","Kramer Novis Pharmaceuticals within reach of patients NO SUGAR NO ALCOHOL • NO DYE NO SACCHARIN • NO ASPARTAME Specially formulated for patients with High Blood Pressure Decongestant Free COUGH SUPPRESSANT Dextromethorphan HBr ​EXPECTORANT Guaifenesin Grape Flavor 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":"6","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 phelgm (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."]}