{"active_ingredient":["Active ingredients (in each 1 mL) Dextromethorphan HBr, 5 mg Guaifenesin, 50 mg Phenylephrine HCl, 2.5 mg"],"dosage_and_administration":["Directions • do not use more than 6 doses in any 24-hour period. • repeat every 4 hours. • measure with the dosage device provided. Do not use with any other device. • Children 2 to under 6 years of age: 1 mL. • Children under 2 years of age: consult a doctor."],"effective_time":"20251204","id":"ab452649-56eb-4ca6-8e30-03cfd2bcdb2e","inactive_ingredient":["Inactive ingredients citric acid, flavor, glycerin, methylparaben, polyethylene glycol, propylene glycol, propylparaben, purified water, sodium citrate, sorbitol, sucralose."],"indications_and_usage":["Uses • helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes and make coughs more productive • temporarily relieves: • nasal congestion due to hay fever or other upper respiratory allergies (allergic rhinitis) • cough due to minor throat and bronchial irritation as may occur with the common cold"],"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":["Desgen Pediatric"],"generic_name":["DEXTROMETHORPHAN HBR, GUIAFENESIN, PHENYLEPHRINE HCL"],"is_original_packager":[true],"manufacturer_name":["Kramer Novis"],"nui":["N0000193956","N0000008867","N0000009560"],"package_ndc":["52083-641-01"],"pharm_class_epc":["Expectorant [EPC]"],"pharm_class_pe":["Decreased Respiratory Secretion Viscosity [PE]","Increased Respiratory Secretions [PE]"],"product_ndc":["52083-641"],"product_type":["HUMAN OTC DRUG"],"route":["ORAL"],"rxcui":["1095503"],"spl_id":["ab452649-56eb-4ca6-8e30-03cfd2bcdb2e"],"spl_set_id":["12425c1b-8bdc-446b-83dd-95e05a4d9b8c"],"substance_name":["DEXTROMETHORPHAN HYDROBROMIDE","GUAIFENESIN","PHENYLEPHRINE HYDROCHLORIDE"],"unii":["9D2RTI9KYH","495W7451VQ","04JA59TNSJ"],"upc":["0352083641015"]},"package_label_principal_display_panel":["Packaging Desgen"],"purpose":["Purposes Cough Suppressant Expectorant Nasal Decongestant"],"questions":["Questions or comments? call weekdays from 8 am to 4 pm AST at 1.787.767.2072"],"set_id":"12425c1b-8bdc-446b-83dd-95e05a4d9b8c","spl_product_data_elements":["Desgen Pediatric Dextromethorphan Hbr, Guiafenesin, Phenylephrine HCl DEXTROMETHORPHAN HYDROBROMIDE DEXTROMETHORPHAN GUAIFENESIN GUAIFENESIN PHENYLEPHRINE HYDROCHLORIDE PHENYLEPHRINE CITRIC ACID MONOHYDRATE GLYCERIN METHYLPARABEN POLYETHYLENE GLYCOL, UNSPECIFIED PROPYLENE GLYCOL PROPYLPARABEN WATER SODIUM CITRATE, UNSPECIFIED FORM SORBITOL SUCRALOSE"],"spl_unclassified_section":["Drug Facts","Cough Suppressant Expectorant Nasal Decongestant Sugar, Alcohol & Dye Free Kramer Novis Pharmaceuticals within reach of patients Manufactured in the USA for Kramer Novis, San Juan, PR 00917. www.kramernovis.com"],"storage_and_handling":["Other information • Tamper Evident Feature: Do not use if cap seal is torn, broken or missing. For your protection, this bottle has an imprinted seal around the neck. • Store at controlled room temperature 15-30°C (59-86°F). • Avoid excessive heat and humidity."],"version":"5","warnings":["Warnings Do not use in a child who is 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 child's prescription drug contains a MAOI, ask a doctor or pharmacist before giving this product. Ask a doctor before use if the child has • heart disease • thyroid disease • high blood pressure • diabetes • cough that occurs with too much phlegm (mucus) • cough that lasts or is chronic such as occurs with asthma. When using this product, do not use more than directed. Stop use and ask a doctor if • your child gets 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. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away."]}