{"active_ingredient":["Active ingredients (in each 5 mL, 1 teaspoon) Dextromethorphan HBr, 10 mg Guaifenesin, 200 mg Phenylephrine HCl, 5 mg"],"dosage_and_administration":["​Directions do not take more than 6 doses in any 24-hour period. age dose Adults and Children 12 years of age and over 2 teaspoons (10 mL) every 4 hours Children 6 to under 12 years of age 1 teaspoon (5 mL) every 4 hours Children under 6 years of age do not use"],"dosage_and_administration_table":["
age dose
Adults and Children 12 years of age and over 2 teaspoons (10 mL) every 4 hours
Children 6 to under 12 years of age 1 teaspoon (5 mL) every 4 hours
Children under 6 years of age do not use
"],"effective_time":"20251112","id":"c3363889-6ee4-4e45-9233-712513223055","inactive_ingredient":["Inactive ingredients citric acid, FD&C Red 40, flavor, glycerin, methylparaben, propylene glycol, propylparaben, purified water, sodium citrate, sucralose."],"indications_and_usage":["Uses • helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes • temporarily relieves these symptoms occurring with a cold: • nasal congestion • cough due to minor throat and bronchial irritation"],"keep_out_of_reach_of_children":["Keep out of reach of children. In case of accidental overdose, get medical help or contact a Poison Control Center right away."],"openfda":{"application_number":["M012"],"brand_name":["Presgen"],"generic_name":["GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE, DEXTROMETHORPHAN HYDROBROMIDE"],"is_original_packager":[true],"manufacturer_name":["Kramer Novis"],"nui":["N0000193956","N0000008867","N0000009560"],"package_ndc":["52083-632-16"],"pharm_class_epc":["Expectorant [EPC]"],"pharm_class_pe":["Decreased Respiratory Secretion Viscosity [PE]","Increased Respiratory Secretions [PE]"],"product_ndc":["52083-632"],"product_type":["HUMAN OTC DRUG"],"route":["ORAL"],"rxcui":["1098647"],"spl_id":["c3363889-6ee4-4e45-9233-712513223055"],"spl_set_id":["edad7a86-0d27-4a98-85b2-4b6725904f28"],"substance_name":["DEXTROMETHORPHAN HYDROBROMIDE","GUAIFENESIN","PHENYLEPHRINE HYDROCHLORIDE"],"unii":["9D2RTI9KYH","495W7451VQ","04JA59TNSJ"]},"package_label_principal_display_panel":["Packaging Presgen"],"purpose":["Purpose Cough Suppressant Expectorant Nasal Decongestant"],"questions":["Questions or comments? Call weekdays from 8AM to 4PM AST at ​1.787.767.2072"],"set_id":"edad7a86-0d27-4a98-85b2-4b6725904f28","spl_product_data_elements":["Presgen guaifenesin, phenylephrine hydrochloride, dextromethorphan hydrobromide DEXTROMETHORPHAN HYDROBROMIDE DEXTROMETHORPHAN GUAIFENESIN GUAIFENESIN PHENYLEPHRINE HYDROCHLORIDE PHENYLEPHRINE CITRIC ACID MONOHYDRATE FD&C RED NO. 40 GLYCERIN METHYLPARABEN PROPYLENE GLYCOL PROPYLPARABEN WATER SODIUM CITRATE, UNSPECIFIED FORM SUCRALOSE SOUR CHERRY CHERRY RED"],"spl_unclassified_section":["​Drug Facts","​Compare to Tussi-Pres ® COUGH SUPPRESSANT Dextromethorphan HBr EXPECTORANT Guaifenesin ​ NASAL DECONGESTANT Phenylephrine HCl ​ SUGAR AND ALCOHOL FREE SACCHARIN FREE SORBITOL FREE CHERRY FLAVOR ​ 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 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 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 a 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 • trouble urinating due to enlarged prostate gland • 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 exceed recommended dosage. Stop use and ask a doctor if • you get nervous, dizzy, or sleepless • symptoms do not get better within 7 days or are accompanied by fever • 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 accidental overdose, get medical help or contact a Poison Control Center right away."]}