{"active_ingredient":["Active ingredients (in each 5 mL teaspoonful) Dextromethorphan HBr 5 mg Guaifenesin 75 mg Phenylephrine HCl 2.5 mg"],"dosage_and_administration":["Directions • do not exceed 6 doses in any 24-hour period • mL = milliliter, tsp = teaspoon children 6 to under 12 years of age 10 mL (2 tsp) every 4 hours children 2 to under 6 years of age 5 mL (1 tsp) every 4 hours children under 2 years of age consult a doctor"],"dosage_and_administration_table":["
children 6 to under 12 years of age 10 mL (2 tsp) every 4 hours
children 2 to under 6 years of age 5 mL (1 tsp) every 4 hours
children under 2 years of age consult a doctor
"],"effective_time":"20260115","id":"e0485b3d-5021-4c2e-aa88-b10bcc2511a5","inactive_ingredient":["Inactive ingredients citric acid, flavor, glycerin, methylparaben, propylene glycol, propylparaben, purified water, sodium citrate, sucralose"],"indications_and_usage":["Uses • helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive • temporarily relieves: • nasal congestion due to the common cold • cough due to minor throat and bronchial irritation associated with a cold or inhaled irritants"],"keep_out_of_reach_of_children":["Keep out of reach of children . In case of accidental overdose, seek professional assistance or contact a poison control center immediately."],"openfda":{"application_number":["M012"],"brand_name":["ACTINEL DM Pediatric"],"generic_name":["DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE"],"is_original_packager":[true],"manufacturer_name":["ACTIPHARMA, LLC"],"nui":["N0000193956","N0000008867","N0000009560"],"package_ndc":["63102-130-16"],"pharm_class_epc":["Expectorant [EPC]"],"pharm_class_pe":["Decreased Respiratory Secretion Viscosity [PE]","Increased Respiratory Secretions [PE]"],"product_ndc":["63102-130"],"product_type":["HUMAN OTC DRUG"],"route":["ORAL"],"rxcui":["1119541"],"spl_id":["e0485b3d-5021-4c2e-aa88-b10bcc2511a5"],"spl_set_id":["f85d8586-423f-48a3-9bb2-bbc5984c7cd3"],"substance_name":["DEXTROMETHORPHAN HYDROBROMIDE","GUAIFENESIN","PHENYLEPHRINE HYDROCHLORIDE"],"unii":["9D2RTI9KYH","495W7451VQ","04JA59TNSJ"]},"package_label_principal_display_panel":["Packaging ACTINEL​ DM Pediatric"],"purpose":["Purposes Cough suppressant Expectorant Nasal decongestant"],"questions":["Questions or comments? 1.787.608.0882 ​ You may also report serious side effects to this phone number. Call weekdays from 8AM to 4PM AST"],"set_id":"f85d8586-423f-48a3-9bb2-bbc5984c7cd3","spl_product_data_elements":["ACTINEL DM Pediatric Dextromethorphan Hydrobromide, Guaifenesin, Phenylephrine Hydrochloride DEXTROMETHORPHAN HYDROBROMIDE DEXTROMETHORPHAN GUAIFENESIN GUAIFENESIN PHENYLEPHRINE HYDROCHLORIDE PHENYLEPHRINE CITRIC ACID MONOHYDRATE GLYCERIN METHYLPARABEN PROPYLENE GLYCOL PROPYLPARABEN WATER SODIUM CITRATE, UNSPECIFIED FORM SUCRALOSE Strawberry Banana"],"spl_unclassified_section":["Drug Facts","Alcohol, Dye & Sugar FREE Contains the same active ingredients as Tusnel ​® ​ DM Pediatric* ActiPharma COMMITTED TO HEALTH AND WELL-BEING WWW.ACTIPHARMA.NET Manufactured for Actipharma San Juan, PR 00917. Manufactured in USA with imported ingredients ​ * Tusnel® DM Pediatric is a registered trademark of Llorens Pharmaceutical. This product is not manufactured, distributed or marketed by Llorens Pharmaceutical."],"storage_and_handling":["Other information • tamper evident feature: Do not use if inner seal is torn, cut, or opened • store at controlled room temperature 15°- 30°C (59° - 86°F) • avoid excessive heat or humidity."],"version":"1","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 an MAOI, ask a doctor or pharmacist before giving this product. Ask a doctor before use if your child has • heart disease • high blood pressure • thyroid disease • diabetes • cough accompanied by excessive phlegm (mucus) • persistent or chronic cough such 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 improve within 7 days or are accompanied by fever • cough persists for more than 1 week, tends to recur, or is accompanied by fever, rash, or a persistent headache. These could be signs of a serious condition. Keep out of reach of children . In case of accidental overdose, seek professional assistance or contact a poison control center immediately."]}