{"active_ingredient":["Active Ingredients (in each 5 mL tsp) Dextromethorphan HBr, 15 mg Guaifenesin, 200 mg Pseudoephedrine HCl, 30 mg"],"dosage_and_administration":["Directions • do not take more than 4 doses in any 24-hour period. AGE DOSE Adults and children 12 years of age and over Take 2 teaspoonfuls (10 mL) every 6 hours Children under 12 years of age do not use"],"dosage_and_administration_table":["
AGEDOSE
Adults and children 12 years of age and over Take 2 teaspoonfuls (10 mL) every 6 hours
Children under 12 years of age do not use
"],"effective_time":"20250708","id":"11f69bba-6b7f-4876-a8ba-123264408164","inactive_ingredient":["Inactive ingredients Citric Acid, Flavor, Methylparaben, Potassium Citrate, Propylene Glycol, Propylparaben, Purified Water, Sorbitol, Sucralose"],"indications_and_usage":["​Uses • temporarily relieves cough due to minor throat and bronchial irritation associated with the common cold • helps control the cough reflex that causes coughing • helps loosen phlegm (mucus) and thin bronchial secretions to make cough more productive • temporarily relieves nasal congestion due to the common cold, hay fever, or other upper respiratory allergies (allergic rhinitis)."],"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"],"generic_name":["DEXTROMETHORPHAN HBR,GUAIFENESIN,PSEUDOEPHEDRINE HCL"],"is_original_packager":[true],"manufacturer_name":["ACTIPHARMA, LLC"],"nui":["N0000193956","N0000008867","N0000009560"],"package_ndc":["63102-101-16"],"pharm_class_epc":["Expectorant [EPC]"],"pharm_class_pe":["Decreased Respiratory Secretion Viscosity [PE]","Increased Respiratory Secretions [PE]"],"product_ndc":["63102-101"],"product_type":["HUMAN OTC DRUG"],"route":["ORAL"],"rxcui":["1098227"],"spl_id":["11f69bba-6b7f-4876-a8ba-123264408164"],"spl_set_id":["db0cb6ae-0a4d-4232-805a-f3f3a058261f"],"substance_name":["DEXTROMETHORPHAN HYDROBROMIDE","GUAIFENESIN","PSEUDOEPHEDRINE HYDROCHLORIDE"],"unii":["9D2RTI9KYH","495W7451VQ","6V9V2RYJ8N"]},"package_label_principal_display_panel":["Packaging ACTINEL-101"],"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":"db0cb6ae-0a4d-4232-805a-f3f3a058261f","spl_product_data_elements":["ACTINEL 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","NEW FORMULA Contains the same active ingredients as Tusne l ®* 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® 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 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 • trouble urinating due to an enlarged prostate gland • cough that occurs with too much phlegm (mucus) • cough that lasts or is chronic 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 product do not use more than directed. Stop use and ask a doctor if • you get 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."]}