{"active_ingredient":["Active ingredients (in each 5 mL tsp) Dextromethorphan HBr 10 mg Guaifenesin 187 mg Pseudoephedrine HCl 30 mg"],"dosage_and_administration":["Directions do not exceed more than 6 doses in any 24-hour period. AGE DOSE Adults and children 12 years of age and over Take 2 teaspoonfuls (10 mL) every 4 hours Children 6 to under 12 years of age Take 1 teaspoonful (5 mL) every 4 hours Children under 6 years of age Ask physician"],"dosage_and_administration_table":["
AGE DOSE
Adults and children 12 years of age and over Take 2 teaspoonfuls (10 mL) every 4 hours
Children 6 to under 12 years of age Take 1 teaspoonful (5 mL) every 4 hours
Children under 6 years of age Ask physician
"],"effective_time":"20250717","id":"109b340a-cf73-4886-87d5-edf2702f6a2c","inactive_ingredient":["Inactive ingredients citric acid, grape flavor, methylparaben, monoammonium glycyrrhizinate, 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 a cold or inhaled irritants • helps loosen phlegm and thin bronchial secretions to make coughs more productive • temporarily relieves nasal congestion"],"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":["ACTISPEC PSE"],"generic_name":["DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PSEUDOEPHEDRINE HYDROCHLORIDE"],"is_original_packager":[true],"manufacturer_name":["ACTIPHARMA, LLC"],"nui":["N0000193956","N0000008867","N0000009560"],"package_ndc":["63102-120-16"],"pharm_class_epc":["Expectorant [EPC]"],"pharm_class_pe":["Decreased Respiratory Secretion Viscosity [PE]","Increased Respiratory Secretions [PE]"],"product_ndc":["63102-120"],"product_type":["HUMAN OTC DRUG"],"route":["ORAL"],"rxcui":["1435143"],"spl_id":["109b340a-cf73-4886-87d5-edf2702f6a2c"],"spl_set_id":["5def1555-87f4-41d5-8a5c-be560aa8f1e2"],"substance_name":["DEXTROMETHORPHAN HYDROBROMIDE","GUAIFENESIN","PSEUDOEPHEDRINE HYDROCHLORIDE"],"unii":["9D2RTI9KYH","495W7451VQ","6V9V2RYJ8N"]},"package_label_principal_display_panel":["Packaging ACTISPEC PSE"],"purpose":["Purpose Cough Suppressant Expectorant Nasal Decongestant"],"questions":["Questions or comments? call weekdays from 8 AM to 4PM AST at 1.787.608.0882."],"set_id":"5def1555-87f4-41d5-8a5c-be560aa8f1e2","spl_product_data_elements":["ACTISPEC PSE Dextromethorphan Hydrobromide, Guaifenesin, Pseudoephedrine Hydrochloride DEXTROMETHORPHAN HYDROBROMIDE DEXTROMETHORPHAN GUAIFENESIN GUAIFENESIN PSEUDOEPHEDRINE HYDROCHLORIDE PSEUDOEPHEDRINE CITRIC ACID MONOHYDRATE METHYLPARABEN AMMONIUM GLYCYRRHIZATE POTASSIUM CITRATE PROPYLENE GLYCOL PROPYLPARABEN WATER SORBITOL SUCRALOSE"],"spl_unclassified_section":["Drug Facts","Contains the same active ingredients as Trispec ® PSE * Alcohol FREE Dye FREE Sugar FREE Grape Flavor Manufactured in USA with imported ingredients for ActiPharma LLC. San Juan, PR 00917. www.actipharma.net. Rev. 04/25 * Trispec ® PSE is a registered trademark of Deliz Pharmaceutical Corp. This product is not manufactured, distributed or marketed by Deliz 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":"1","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 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 • 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. These could be signs of a serious condition. If pregnant or breast-feeding , ask a health professional before use."]}