{"active_ingredient":["Active ingredients (in each 5 mL tsp) Dextromethorphan HBr 20 mg Guaifenesin 400 mg Phenylephrine HCl 10 mg"],"dosage_and_administration":["Directions take every 4 hours, or as directed by a doctor. AGE DOSE adults and children 12 years of age and over take 5mL (1tsp). Do not exceed 6 doses in 24 hours Children under 12 years of age ask a doctor"],"dosage_and_administration_table":["
AGEDOSE
adults and children 12 yearsof age and over take 5mL (1tsp). Do notexceed 6 doses in 24 hours
Children under 12 years of age ask a doctor
"],"effective_time":"20240628","id":"a0ce93a6-b45b-4f6f-a9b6-4be407871774","inactive_ingredient":["Inactive ingredients artificial and natural flavors, citric acid, glycerin, menthol, methylparaben, polyethylene glycol, propylparaben, purified water, sodium citrate, 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 DM"],"generic_name":["DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL"],"is_original_packager":[true],"manufacturer_name":["ACTIPHARMA, LLC"],"nui":["N0000193956","N0000008867","N0000009560"],"package_ndc":["63102-104-16"],"pharm_class_epc":["Expectorant [EPC]"],"pharm_class_pe":["Decreased Respiratory Secretion Viscosity [PE]","Increased Respiratory Secretions [PE]"],"product_ndc":["63102-104"],"product_type":["HUMAN OTC DRUG"],"route":["ORAL"],"rxcui":["1091331"],"spl_id":["a0ce93a6-b45b-4f6f-a9b6-4be407871774"],"spl_set_id":["16660d82-524b-42ca-8581-48237caa13b2"],"substance_name":["DEXTROMETHORPHAN HYDROBROMIDE","GUAIFENESIN","PHENYLEPHRINE HYDROCHLORIDE"],"unii":["9D2RTI9KYH","495W7451VQ","04JA59TNSJ"]},"package_label_principal_display_panel":["Packaging ACTINEL DM"],"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":"16660d82-524b-42ca-8581-48237caa13b2","spl_product_data_elements":["ACTINEL DM Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl DEXTROMETHORPHAN HYDROBROMIDE DEXTROMETHORPHAN GUAIFENESIN GUAIFENESIN PHENYLEPHRINE HYDROCHLORIDE PHENYLEPHRINE CITRIC ACID MONOHYDRATE GLYCERIN MENTHOL, UNSPECIFIED FORM METHYLPARABEN POLYETHYLENE GLYCOL 400 PROPYLPARABEN WATER SODIUM CITRATE, UNSPECIFIED FORM SUCRALOSE"],"spl_unclassified_section":["Drug Facts","Contains the same active ingredients as Tusnel ® DM * • Alcohol FREE • Dye FREE • Sugar FREE • Great Flavor Manufactured in USA with imported ingredients for ActiPharma. San Juan, PR 00917. www.actipharma.net. * Tusnel® DM 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 safety seal is torn, broken or missing. • store at controlled room temperature 15 ° - 30 ° C (59 ° - 86 ° F). • avoid excessive heat or humidity."],"version":"2","warnings":["Warnings Do not use if you are now 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 prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product. Ask a doctor before use if you have • heart disease • high blood pressure • thyroid disease • diabetes • difficulty in urination due to enlargement of the prostate gland • cough accompanied by excessive phlegm (mucus) • persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis or emphysema. Ask a doctor or pharmacist before use if you are taking any other oral nasal decongestant or stimulant. When using this produ ct do not exceed recommended dosage. Stop use and ask a doctor if • nervousness, dizziness, or sleeplessness occur • 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. A persistent cough may be a sign 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."]}