{"active_ingredient":["Active Ingredients (in each 5 mL tsp) Dextromethorphan HBr, 5 mg Guaifenesin, 50 mg Pseudoephedrine HCl, 15 mg"],"dosage_and_administration":["Directions • do not take more than 4 doses in any 24-hour period. AGE DOSE Children 6 to under 12 years of age Take 2 teaspoonfuls (10 mL) every 4-6 hours Children 2 to under 6 years of age Take 1 teaspoonfuls (5 mL) every 4-6 hours Children under 2 years of age Ask a doctor"],"dosage_and_administration_table":["
AGEDOSE
Children 6 to under 12 years of ageTake 2 teaspoonfuls (10 mL) every 4-6 hours
Children 2 to under 6 years of age Take 1 teaspoonfuls (5 mL) every 4-6 hours
Children under 2 years of ageAsk a doctor
"],"effective_time":"20250708","id":"eb2ae74b-0abd-4451-a6a3-f2c5b0fbcfbf","inactive_ingredient":["Inactive ingredients Citric Acid, Flavor, Methylparaben, Potassium Citrate, Propylene Glycol, Propylparaben, Purified Water, Sorbitol, 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 overdose, get medical help or contact a Poison Control Center right away."],"openfda":{"application_number":["M012"],"brand_name":["ACTINEL PEDIATRIC"],"generic_name":["DEXTROMETHORPHAN HBR,GUAIFENESIN,PSEUDOEPHEDRINE HCL"],"is_original_packager":[true],"manufacturer_name":["ACTIPHARMA, LLC"],"nui":["N0000193956","N0000008867","N0000009560"],"package_ndc":["63102-102-16"],"pharm_class_epc":["Expectorant [EPC]"],"pharm_class_pe":["Decreased Respiratory Secretion Viscosity [PE]","Increased Respiratory Secretions [PE]"],"product_ndc":["63102-102"],"product_type":["HUMAN OTC DRUG"],"route":["ORAL"],"rxcui":["1098911"],"spl_id":["eb2ae74b-0abd-4451-a6a3-f2c5b0fbcfbf"],"spl_set_id":["6bb92d74-4893-40b8-af58-eb307155e876"],"substance_name":["DEXTROMETHORPHAN HYDROBROMIDE","GUAIFENESIN","PSEUDOEPHEDRINE HYDROCHLORIDE"],"unii":["9D2RTI9KYH","495W7451VQ","6V9V2RYJ8N"],"upc":["0663102102166"]},"package_label_principal_display_panel":["Packaging Pediatric-102"],"purpose":["Purposes Cough Suppressant Expectorant Nasal Decongestant"],"questions":["Questions or comments? call weekdays from 8AM to 4PM AST at 1.787.608.0882"],"set_id":"6bb92d74-4893-40b8-af58-eb307155e876","spl_product_data_elements":["ACTINEL PEDIATRIC Dextromethorphan HBr,Guaifenesin,Pseudoephedrine HCl DEXTROMETHORPHAN HYDROBROMIDE DEXTROMETHORPHAN GUAIFENESIN GUAIFENESIN PSEUDOEPHEDRINE HYDROCHLORIDE PSEUDOEPHEDRINE CITRIC ACID MONOHYDRATE METHYLPARABEN POTASSIUM CITRATE PROPYLENE GLYCOL PROPYLPARABEN WATER SORBITOL SUCRALOSE"],"spl_unclassified_section":["​Drug Facts","Contains the same active ingredients as Tusnel ® Pediatric* SUGAR FREE DYE FREE ALCOHOL FREE SACCHARIN FREE COMMITTED TO HEALTH AND WELL-BEING WWW.ACTIPHARMA.NET Manufactured in USA with imported ingredients for ActiPharma, Inc. San Juan, PR 00917. * Tusnel® Pediatric is a registered trademark of Llorens Pharmaceutical Corp. This product is not manufactured, distributed or marketed by Llorens Pharmaceutical Corp."],"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":"6","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 that occurs with too much phlegm (mucus) • a persistent or chronic cough such as occurs with asthma Ask a doctor or pharmacist before use if your child is taking any other oral nasal decongestant or stimulant. When using this product do not use more than directed. Stop use and ask a doctor if 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."]}