{"active_ingredient":["Active Ingredients (in each 7.5 mL, 1 ½ teaspoon) Dextromethorphan HBr, 15 mg Guaifenesin (Glyceryl Guaiacolate), 150mg"],"dosage_and_administration":["Directions • do not take more than 6 doses in any 24-hour period. • mL = milliliter • tsp = teaspoon age dose Adults and children 12 years of age and over 2 teaspoonfuls (10 mL) every 4 hours Children under 12 years of age Consult a physician"],"dosage_and_administration_table":["
age dose
Adults and children 12 years of age and over 2 teaspoonfuls (10 mL) every 4 hours
Children under 12 years of age Consult a physician
"],"effective_time":"20251112","id":"796f9d98-f855-437f-9bca-bb322fa5b063","inactive_ingredient":["Inactive Ingredients Citric acid, flavor, glycerin, methylparaben, propylene glycol, propylparaben, purified water, sorbitol, sucralose."],"indications_and_usage":["Uses temporarily relieves cough due to minor throat and bronchial irritation as may occur with a cold helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus, drain bronchial tubes, and make coughs more productive"],"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":["Sorbugen"],"generic_name":["DEXTROMETHORPHAN HYDROBROMIDE, GLYCEROL GUAIACOLATE"],"is_original_packager":[true],"manufacturer_name":["Kramer Novis"],"nui":["N0000193956","N0000008867","N0000009560"],"package_ndc":["52083-660-16"],"pharm_class_epc":["Expectorant [EPC]"],"pharm_class_pe":["Decreased Respiratory Secretion Viscosity [PE]","Increased Respiratory Secretions [PE]"],"product_ndc":["52083-660"],"product_type":["HUMAN OTC DRUG"],"route":["ORAL"],"rxcui":["996520"],"spl_id":["796f9d98-f855-437f-9bca-bb322fa5b063"],"spl_set_id":["a8f2a2d7-0360-45a8-9635-c852f4a7d7ba"],"substance_name":["DEXTROMETHORPHAN HYDROBROMIDE","GUAIFENESIN"],"unii":["9D2RTI9KYH","495W7451VQ"],"upc":["0352083660160"]},"package_label_principal_display_panel":["Packaging Sorbugen"],"purpose":["Purposes Antitussive Expectorant"],"questions":["Questions or comments? 1-787-767-2072 You may also report serious side effects to this phone number. Call weekdays from 8AM to 4PM AST"],"set_id":"a8f2a2d7-0360-45a8-9635-c852f4a7d7ba","spl_product_data_elements":["Sorbugen dextromethorphan hydrobromide, glycerol guaiacolate DEXTROMETHORPHAN HYDROBROMIDE DEXTROMETHORPHAN GUAIFENESIN GUAIFENESIN CITRIC ACID MONOHYDRATE GLYCERIN METHYLPARABEN PROPYLENE GLYCOL PROPYLPARABEN WATER SORBITOL SUCRALOSE SWEET GRAPE"],"spl_unclassified_section":["Drug Facts","Contains the same active ingredients as Sorbutuss® NR* Dextromethorphan HBr ANTITUSSIVE Guaifenesin (Glyceryl Guaiacolate) EXPECTORANT Antihistamine & Decongestant Free ​SUGAR, DYE & ALCOHOL FREE GRAPE FLAVOR KramerNovis Pharmaceuticals within reach of patients Manufactured in USA with imported ingredients for Kramer Novis, San Juan, PR 00917. www.kramernovis.com *Sorbutuss® NR is a registered trademark of Teral, Inc. This product is not manufactured, distributed or marketed by Teral, Inc."],"storage_and_handling":["Other information Tamper evident feature: Do not use if printed security seal is torn, broken or missing. Store at controlled room temperature 15-30°C (59-86°F). Avoid excessive heat or humidity."],"version":"7","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 • cough that occurs with too much phlegm (mucus) • cough that lasts or is chronic such as occurs with smoking, asthma, chronic bronchitis or emphysema. When using this product, do not use more than directed. Stop use and ask a doctor if • 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."]}