{"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=\"50%\"><tbody><tr><td styleCode=\"Botrule Rrule\"> adults and children 12 years and older</td><td> take 2 softgels every 6 to 8 hours, as needed </td></tr><tr><td> children under 12 years</td><td styleCode=\"Lrule Toprule\"> do not use</td></tr></tbody></table>"],"effective_time":"20260525","id":"b2a18e9c-b6b7-4edd-9e5b-4b07e0ef203b","inactive_ingredient":["Inactive ingredients FD&C Blue No. 1, FD&C Red No. 40, gelatin, glycerin, polyethylene glycol 400, propyl gallate, propylene glycol, purified water, Polyvinylpyrrolidone, 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":["Cough Suppressant Adult"],"generic_name":["DEXTROMETHORPHAN HYDROBROMIDE"],"is_original_packager":[true],"manufacturer_name":["Rugby Laboratories"],"package_ndc":["0536-1480-34"],"product_ndc":["0536-1480"],"product_type":["HUMAN OTC DRUG"],"route":["ORAL"],"rxcui":["1090487"],"spl_id":["b2a18e9c-b6b7-4edd-9e5b-4b07e0ef203b"],"spl_set_id":["47b713bd-4c1e-f44a-e063-6294a90a63d3"],"substance_name":["DEXTROMETHORPHAN HYDROBROMIDE"],"unii":["9D2RTI9KYH"],"upc":["0305361480349"]},"package_label_principal_display_panel":["Packaging Cough Suppressant"],"purpose":["Purpose Cough Suppressant"],"questions":["Questions or comments? Call 1-888-577-8033 Monday-Friday 8AM-4PM EST"],"set_id":"47b713bd-4c1e-f44a-e063-6294a90a63d3","spl_product_data_elements":["Cough Suppressant Adult Dextromethorphan Hydrobromide DEXTROMETHORPHAN HYDROBROMIDE DEXTROMETHORPHAN FD&C BLUE NO. 1 FD&C RED NO. 40 GELATIN, UNSPECIFIED GLYCERIN POLYETHYLENE GLYCOL 400 PROPYL GALLATE PROPYLENE GLYCOL WATER POVIDONE K30 SORBITOL SORBITAN T"],"spl_unclassified_section":["Drug Facts","Rugby ® NDC 0536-1480-34 compare to the active ingredient in Robitussin ® CoughGels ®* adult cough suppressant dextromethorphan HBr USP 15 mg cough suppressant relieves: • cough for up to 8 hours 20 softgels TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING *This product is not manufactured or distributed by Pfizer Consumer Healthcare, owner of the registered trademark Robitussin ® CoughGels ® . Rev. 02/26 R-173 Re-order No.371275 Distributed by: RUGBY ® LABORATORIES, Indianapolis, IN 46268 (800) 616-2471 www.major-rugby.com Product of India REV.00-012026 LB0536148034"],"storage_and_handling":["Other information • store below 25°C (77°F) • avoid excessive heat above 40°C(104°F) • protect from light"],"version":"3","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 MAΟΙ drug. If you do not know if your prescription drug contains an MAΟΙ, 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 could 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."]}