{"active_ingredient":["Drug Facts Active Ingredients (in each 5 mL teaspoonful) Guaifenesin, USP 100 mg Dextromethorphan Hydrobromide, USP 10 mg"],"dosage_and_administration":["Directions take every 4 hours as needed, or as directed by a doctor do not take more than 6 doses in 24 hours do not exceed recommended dose adults and children 12 years and over 2 teaspoonfuls (10 mL) children under 12 years do not use"],"dosage_and_administration_table":["<table width=\"100%\"><caption/><tbody><tr><td> adults and children 12 years and over</td><td> 2 teaspoonfuls (10 mL)</td></tr><tr><td> children under 12 years</td><td> do not use</td></tr></tbody></table>"],"effective_time":"20251208","id":"e0d8faa2-7ca9-49c9-bae0-138fea576c68","inactive_ingredient":["Inactive Ingredients Cherry flavor, citric acid, FD&C Red #40, glycerin, menthol, propylene glycol, sodium benzoate, sodium citrate dihydrate, sodium saccharin, sorbitol, sucralose, water."],"indications_and_usage":["Uses helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive 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. In case of overdose, get medical help or contact a Poison Control Center right away."],"openfda":{"application_number":["M012"],"brand_name":["Mucolyte DM"],"generic_name":["GUAIFENESIN, DEXTROMETHORPHAN HBR"],"is_original_packager":[true],"manufacturer_name":["Rising Pharma Holdings, Inc."],"nui":["N0000193956","N0000008867","N0000009560"],"package_ndc":["57237-360-12","57237-360-16"],"pharm_class_epc":["Expectorant [EPC]"],"pharm_class_pe":["Decreased Respiratory Secretion Viscosity [PE]","Increased Respiratory Secretions [PE]"],"product_ndc":["57237-360"],"product_type":["HUMAN OTC DRUG"],"route":["ORAL"],"rxcui":["996520"],"spl_id":["e0d8faa2-7ca9-49c9-bae0-138fea576c68"],"spl_set_id":["c913d27d-bc00-4ace-9a5f-c55522e1cd1d"],"substance_name":["GUAIFENESIN","DEXTROMETHORPHAN HYDROBROMIDE"],"unii":["495W7451VQ","9D2RTI9KYH"],"upc":["0357237360163"]},"other_safety_information":["Other Information store at 20°-25°C (68°-77°F) protect from freezing protect from light do not refrigerate TAMPER-EVIDENT: Do not use if foil seal over bottle is torn, broken or missing Pharmacist: Preserve and dispense in tight, light-resistant container with a child resistant cap as defined in the USP","*This product is neither manufactured nor distributed by the owner of the registered trademark Robitussin ® -DM MUCOLYTE-DM TM is a trademark owned by Rising Pharma Holdings, Inc. Distributed by: Rising Pharma Holdings, Inc. East Brunswick, NJ 08816"],"package_label_principal_display_panel":["mucolyte-DM"],"pregnancy_or_breast_feeding":["If pregnant or breast-feeding, ask a health professional before use."],"purpose":["Purposes Expectorant Cough Suppressant"],"questions":["Questions or comments Call 1-844-474-7464"],"set_id":"c913d27d-bc00-4ace-9a5f-c55522e1cd1d","spl_product_data_elements":["Mucolyte DM Guaifenesin, Dextromethorphan HBr CITRIC ACID FD&C RED NO. 40 GLYCERIN MENTHOL PROPYLENE GLYCOL SODIUM BENZOATE SODIUM CITRATE, UNSPECIFIED FORM SODIUM SACCHARIN SORBITOL SUCRALOSE WATER GUAIFENESIN GUAIFENESIN DEXTROMETHORPHAN HYDROBROMIDE DEXTROMETHORPHAN"],"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. Do not use if you have ever had an allergic reaction to any of the ingredients in 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 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."]}