{"active_ingredient":["Active Ingredients (In each 5 mL teaspoon) Dextromethorphan HBr 5 mg Guaifenesin 75 mg Phenylephrine HCl 2.5 mg"],"dosage_and_administration":["Directions: Do not take more than 6 doses in any 24-hour period. Adults & Children 12 years of age and older Take 4 teaspoons (20 mL) every 4 hours, as needed. Children 6 to under 12 years of age Take 2 teaspoons (10 mL) every 4 hours, as needed. Children 2 to under 6 Take one pre-measured single dose package (1 teaspoon or 5 mL) every 4 hours, as needed. Children under 2 years Do not use."],"dosage_and_administration_table":["<table width=\"100%\"><caption/><tbody><tr><td styleCode=\"Lrule Rrule Toprule Botrule\"> Adults &amp; Children 12 years of age and older</td><td styleCode=\"Lrule Rrule Toprule Botrule\"> Take 4 teaspoons (20 mL) every 4 hours, as needed.</td></tr><tr><td styleCode=\"Lrule Rrule Toprule Botrule\"> Children 6 to under 12 years of age</td><td styleCode=\"Lrule Rrule Toprule Botrule\"> Take 2 teaspoons (10 mL) every 4 hours, as needed.</td></tr><tr><td styleCode=\"Lrule Rrule Toprule Botrule\"> Children 2 to under 6</td><td styleCode=\"Lrule Rrule Toprule Botrule\"> Take one pre-measured single dose package (1 teaspoon or 5 mL) every 4 hours, as needed.</td></tr><tr><td styleCode=\"Lrule Rrule Toprule Botrule\"> Children under 2 years</td><td styleCode=\"Lrule Rrule Toprule Botrule\"> Do not use.</td></tr></tbody></table>"],"effective_time":"20251112","id":"e67f6230-a612-4351-b907-a759020a3bda","inactive_ingredient":["Inactive Ingredients: Citric acid, Flavor, Glycerin, Methylparaben, Propylene glycol, Propylparaben, Purified water, Sodium citrate and 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 and cough due to minor throat and bronchial irritation."],"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":["TUSSI PRES PEDIATRIC"],"generic_name":["GUAIFENESIN, PHENYLEPHRINE HCL,DEXTROMETHORPHAN HYDROBROMIDE"],"is_original_packager":[true],"manufacturer_name":["KRAMER NOVIS"],"nui":["N0000193956","N0000008867","N0000009560"],"package_ndc":["52083-232-01","52083-232-04","52083-232-16","52083-232-05"],"pharm_class_epc":["Expectorant [EPC]"],"pharm_class_pe":["Decreased Respiratory Secretion Viscosity [PE]","Increased Respiratory Secretions [PE]"],"product_ndc":["52083-232"],"product_type":["HUMAN OTC DRUG"],"route":["ORAL"],"rxcui":["1119541"],"spl_id":["e67f6230-a612-4351-b907-a759020a3bda"],"spl_set_id":["b01a45df-3cea-4729-80c1-7f35b7f707f0"],"substance_name":["GUAIFENESIN","PHENYLEPHRINE HYDROCHLORIDE","DEXTROMETHORPHAN HYDROBROMIDE"],"unii":["495W7451VQ","04JA59TNSJ","9D2RTI9KYH"],"upc":["0352083232169"]},"package_label_principal_display_panel":["Packaging TUSSIPRESPEDIATRIC"],"purpose":["Purpose Antitussive (Anti-Cough) Expectorant Nasal Decongestant"],"set_id":"b01a45df-3cea-4729-80c1-7f35b7f707f0","spl_product_data_elements":["TUSSI PRES PEDIATRIC GUAIFENESIN, PHENYLEPHRINE HCL,DEXTROMETHORPHAN HYDROBROMIDE GUAIFENESIN GUAIFENESIN PHENYLEPHRINE HYDROCHLORIDE PHENYLEPHRINE DEXTROMETHORPHAN HYDROBROMIDE DEXTROMETHORPHAN CITRIC ACID MONOHYDRATE GLYCERIN METHYLPARABEN PROPYLENE GLYCOL PROPYLPARABEN WATER SODIUM CITRATE, UNSPECIFIED FORM SUCRALOSE CITRUS ORANGE"],"spl_unclassified_section":["Drug Facts","COUGH SUPPRESSANT, EXPECTORANT, NASAL DECONGESTANT SUGAR, ALCOHOL, SACCHARIN, SORBITOL & DYE FREE ORANGE FLAVOR Manufactured in the USA for: Kramer Novis, San Juan, PR 00917. 1 (787) 767-2072 www.kramernovis.com"],"storage_and_handling":["Other Information: • Tamper Evident. Do not use if packet is torn, cut or opened. • Store at controlled room temperature 15° to 30°C (59° to 86°F). • Avoid excessive heat or humidity."],"version":"6","warnings":["Warnings: Do not use: • in a child under 2 years of age. • 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 an MAOI, ask a doctor or pharmacist before taking this product. Ask a doctor before use if your child has: • heart disease • high blood pressure • thyroid disease • diabetes • trouble urinating due to an enlarged prostate gland • cough that occurs with too much phlegm (mucus), or cough that lasts or is chronic such as occurs with asthma, chronic bronchitis or emphysema. Do not use more than the recommended dose. 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. 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."]}