{"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 Lrule Rrule\">adults and children 12 years and older</td><td styleCode=\"Botrule Rrule\" align=\"right\"> take 2 softgels every 6 to 8 hours, as needed</td></tr><tr><td styleCode=\"Lrule Rrule\">children under 12 years</td><td styleCode=\"Rrule\" align=\"right\"> do not use</td></tr></tbody></table>"],"effective_time":"20241214","id":"4d5e303a-af93-4c41-bced-c1041240fe65","inactive_ingredient":["Inactive ingredients edible white ink, FD&C blue #1, FD&C red #40, gelatin, glycerin, isopropyl alcohol, medium chain triglycerides, polyethylene glycol, povidone, propyl gallate, propylene gycol, 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 (1-800-222-1222). 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":["Dextromethorphan HBr 15 mg Liquid Gels"],"generic_name":["DEXTROMETHORPHAN HBR"],"is_original_packager":[true],"manufacturer_name":["RUGBY LABORATORIES"],"package_ndc":["0536-1334-34"],"product_ndc":["0536-1334"],"product_type":["HUMAN OTC DRUG"],"route":["ORAL"],"rxcui":["1090487"],"spl_id":["4d5e303a-af93-4c41-bced-c1041240fe65"],"spl_set_id":["cf3cc387-6642-43fd-999d-688fdaf65d4f"],"substance_name":["DEXTROMETHORPHAN HYDROBROMIDE"],"unii":["9D2RTI9KYH"]},"package_label_principal_display_panel":["Packaging Dextro1"],"purpose":["Purpose Cough Suppressant"],"questions":["Questions or comments? 1-800-645-2158"],"set_id":"cf3cc387-6642-43fd-999d-688fdaf65d4f","spl_product_data_elements":["Dextromethorphan HBr 15 mg Liquid Gels Dextromethorphan HBr DEXTROMETHORPHAN HYDROBROMIDE DEXTROMETHORPHAN FD&C BLUE NO. 1 FD&C RED NO. 40 GELATIN, UNSPECIFIED GLYCERIN ISOPROPYL ALCOHOL MEDIUM-CHAIN TRIGLYCERIDES POLYETHYLENE GLYCOL, UNSPECIFIED POVIDONE, UNSPECIFIED PROPYL GALLATE PROPYLENE GLYCOL WATER SORBITOL SORBITAN 778"],"spl_unclassified_section":["Drug Facts","Rugby ® Compare to the active ingredient in Robitussin ® CoughGels ® * ADULT Relieves: Cough for up to 8 hours Non-Drowsy TAMPER EVIDENT: DO NOT USE IF IMPRINTED SEAL UNDER CAP IS BROKEN OR MISSING FROM BOTTLE *This product is not manufactured or distributed by Pfizer Consumer Healthcare, owner of the registered trademark Robitussin ® CoughGels ® . Distributed by: RUGBY ® LABORATORIES Livonia, MI 48152 www.rugbylaboratories.com Product of UAE Packaged and Quality Assured in the USA"],"storage_and_handling":["Other information • store at 20°-25°C(68°-77°F) • avoid excessive heat above 40°C(104°F) • protect from light"],"version":"4","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 (1-800-222-1222). Prompt medical attention is critical for adults as well as children even if you do not notice any signs or symptoms."]}