{"active_ingredient":["Active ingredients (in each 1 mL) 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":"20250326","id":"e99c9cb7-48a2-4115-8c61-4f7a0a9942bf","inactive_ingredient":["Inactive ingredients Citric acid, glycerin, grape flavor, methylparaben, polyethylene glycol, propylene glycol, propylparaben, purified water, sodium citrate, sucralose, sucrose."],"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 the common cold"],"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":["SUPRESS-PE Pediatric"],"generic_name":["GUIAFENESIN, PHENYLEPHRINE HCL"],"is_original_packager":[true],"manufacturer_name":["Kramer Novis"],"nui":["N0000193956","N0000008867","N0000009560"],"package_ndc":["52083-056-01"],"pharm_class_epc":["Expectorant [EPC]"],"pharm_class_pe":["Decreased Respiratory Secretion Viscosity [PE]","Increased Respiratory Secretions [PE]"],"product_ndc":["52083-056"],"product_type":["HUMAN OTC DRUG"],"route":["ORAL"],"rxcui":["824600"],"spl_id":["e99c9cb7-48a2-4115-8c61-4f7a0a9942bf"],"spl_set_id":["a474171d-5c29-4a80-9d37-00613796211a"],"substance_name":["GUAIFENESIN","PHENYLEPHRINE HYDROCHLORIDE"],"unii":["495W7451VQ","04JA59TNSJ"],"upc":["0352083056017"]},"package_label_principal_display_panel":["Packaging SUPRESS-PE"],"purpose":["Purposes Expectorant Nasal decongestant"],"questions":["Questions or comments? call weekdays from 8 am to 4 pm AST at 1.787.767.2072"],"set_id":"a474171d-5c29-4a80-9d37-00613796211a","spl_product_data_elements":["SUPRESS-PE Pediatric Guiafenesin, Phenylephrine HCl GUAIFENESIN GUAIFENESIN PHENYLEPHRINE HYDROCHLORIDE PHENYLEPHRINE CITRIC ACID MONOHYDRATE GLYCERIN METHYLPARABEN POLYETHYLENE GLYCOL, UNSPECIFIED PROPYLENE GLYCOL PROPYLPARABEN WATER SODIUM CITRATE, UNSPECIFIED FORM SUCRALOSE SUCROSE"],"spl_unclassified_section":["Drug Facts","PEDIATRIC DROPS For Relief of: + Chest Congestion/Mucus + Stuffy Nose + Sinus Congestion Sugar, Dye & Alcohol Free Grape Flavor RETAIN CARTON FOR FULL PRESCRIBING INFORMATION 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. • Store at controlled room temperature 15-30°C (59-86°F). • Avoid excessive heat and humidity."],"version":"4","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 exceed recommended dosage. 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 accidental overdose, get medical help or contact a Poison Control Center right away."]}