{"active_ingredient":["Active ingredient (in each softgel) Dextromethorphan HBr, USP 15 mg"],"dosage_and_administration":["Directions • do not take more than 8 softgels in any 24-hour period • this adult product is not intended for use in children under 12 years of age adults and children 12 years and older take 2 softgels every 6 to 8 hours, as needed children under 12 years do not use"],"dosage_and_administration_table":["<table width=\"40%\"><tbody><tr><td styleCode=\"Botrule Rrule\"> adults and children  12 years and older</td><td styleCode=\"Botrule\"> take 2 softgels every   6 to 8 hours,   as needed</td></tr><tr><td styleCode=\"Rrule\"> children under  12 years</td><td> do not use</td></tr></tbody></table>"],"effective_time":"20240816","id":"b9864639-8295-437e-bcba-e7cc9fce1a30","inactive_ingredient":["Inactive ingredients edible white ink, FD&C blue no.1, FD&C red no. 40, gelatin (bovine), glycerin, isopropyl alcohol, medium chain triglycerides, polyethylene glycol, povidone, propyl gallate, propylene glycol, purified water, sorbitol sorbitan solution"],"indications_and_usage":["Use temporarily relieves cough due to minor throat and bronchial irritation as may occur with a cold."],"keep_out_of_reach_of_children":["Keep out of reach of children. Overdose warning: In case of overdose, get medical help or contact a Poison Control Center right away. Prompt medical attention is critical for adults as well as children even if you do not notice any signs or symptoms."],"openfda":{"application_number":["M012"],"brand_name":["QUALITY CHOICE Long Acting Cough Softgel"],"generic_name":["DEXTROMETHORPHAN HYDROBROMIDE"],"is_original_packager":[true],"manufacturer_name":["Chain Drug Marketing Association, Inc."],"package_ndc":["83324-303-20"],"product_ndc":["83324-303"],"product_type":["HUMAN OTC DRUG"],"route":["ORAL"],"rxcui":["1090487"],"spl_id":["b9864639-8295-437e-bcba-e7cc9fce1a30"],"spl_set_id":["f1ea7dfc-c605-45a1-ad1d-6e636a8a7b1c"],"substance_name":["DEXTROMETHORPHAN HYDROBROMIDE"],"unii":["9D2RTI9KYH"],"upc":["0635515996120"]},"package_label_principal_display_panel":["Packaging Adult cough Softgels"],"purpose":["Purpose Cough Suppressant"],"questions":["Questions or comments? 1-888-577-8033 Monday - Friday 8am - 4pm EST"],"set_id":"f1ea7dfc-c605-45a1-ad1d-6e636a8a7b1c","spl_product_data_elements":["QUALITY CHOICE Long Acting Cough Softgel Dextromethorphan hydrobromide DEXTROMETHORPHAN HYDROBROMIDE DEXTROMETHORPHAN FD&C BLUE NO. 1 FD&C RED NO. 40 GELATIN TYPE B BOVINE (230 BLOOM) GLYCERIN ISOPROPYL ALCOHOL MEDIUM-CHAIN TRIGLYCERIDES POLYETHYLENE GLYCOL, UNSPECIFIED POVIDONE, UNSPECIFIED PROPYL GALLATE PROPYLENE GLYCOL WATER SORBITOL SORBITAN 778"],"spl_unclassified_section":["Drug Facts","Compare to the Active Ingredient in Robitussin ® CoughGels ® * Adult Relieves cough for up to 8 Hours READ AND KEEP OUTER CARTON FOR COMPLETE PRODUCT WARNINGS AND INFORMATION TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING QC 100% SATISFACTION GUARANTEED ® Distributed by CDMA, Inc. Novi, MI 48375 www.qualitychoice.com Questions: 800-935-2362 PRODUCT OF UNITED ARAB EMIRATES *This product is not manufactured or distributed by Pfizer Consumer Healthcare, owner of the registered trademark Robitussin ® CoughGels ® ."],"storage_and_handling":["Other information • store at room temperature between 20°-25°C (68°-77°F) • avoid excessive heat above 40°C (104°F) • protect from light, heat and moisture"],"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 • a cough that occurs with too much phlegm (mucus) • a cough that lasts or is chronic as occurs with smoking, asthma, or emphysema Stop use and ask a doctor if cough lasts for more than 7 days, comes back, or is accompanied by fever, rash, or persistent headache. These can be signs of a serious condition. If pregnant or breast-feeding , ask a health professional before use. Keep out of reach of children. Overdose warning: In case of overdose, get medical help or contact a Poison Control Center right away. Prompt medical attention is critical for adults as well as children even if you do not notice any signs or symptoms."]}