{"active_ingredient":["Active ingredient (in each 10 mL Cup) Guaifenesin 200 mg Dextromethorphan Hydrobromide 20 mg"],"ask_doctor":["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"],"dosage_and_administration":["Directions Follow dosage below or use as directed by a physician. do not take more than 6 doses in any 24-hour period. Age (yr) Dose (mL) adults and children 12 years and over 10 mL (2 teaspoonfuls) every 4 hours children 6 years to under 12 years 5 mL (1 teaspoonful) every 4 hours children 2 years to under 6 years 2.5 mL (1/2 teaspoonful) every 4 hours children under 2 years ask a doctor"],"dosage_and_administration_table":["
Age (yr)Dose (mL)
adults and children 12 years and over10 mL (2 teaspoonfuls) every 4 hours
children 6 years to under 12 years5 mL (1 teaspoonful) every 4 hours
children 2 years to under 6 years2.5 mL (1/2 teaspoonful) every 4 hours
children under 2 yearsask a doctor
"],"effective_time":"20240804","id":"1d74f48d-1aa4-b779-e063-6394a90af176","inactive_ingredient":["Inactive Ingredients citric acid, FD&C Red No. 40, flavoring, glycerin, menthol, purified water, sodium benzoate, sodium citrate, sodium saccharin, and sucrose."],"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":["Guaifenesin DM"],"generic_name":["GUAIFENESIN AND DEXTROMETHORPHAN"],"is_original_packager":[true],"manufacturer_name":["American Health Packaging"],"nui":["N0000193956","N0000008867","N0000009560","N0000181821","N0000182149","N0000181819","N0000182147"],"package_ndc":["60687-828-42","60687-828-48","60687-828-56"],"pharm_class_epc":["Expectorant [EPC]","Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC]","Sigma-1 Agonist [EPC]"],"pharm_class_moa":["Uncompetitive NMDA Receptor Antagonists [MoA]","Sigma-1 Receptor Agonists [MoA]"],"pharm_class_pe":["Decreased Respiratory Secretion Viscosity [PE]","Increased Respiratory Secretions [PE]"],"product_ndc":["60687-828"],"product_type":["HUMAN OTC DRUG"],"route":["ORAL"],"rxcui":["996520"],"spl_id":["1d74f48d-1aa4-b779-e063-6394a90af176"],"spl_set_id":["8632a655-7f5b-450f-95fa-62478a174e9c"],"substance_name":["GUAIFENESIN","DEXTROMETHORPHAN"],"unii":["495W7451VQ","7355X3ROTS"]},"other_safety_information":["Other Information Each 10 mL contains: sodium 8 mg Store at controlled room temperature between 20° to 25°C (68° to 77°F) [see USP]. Protect from light. DO NOT USE IF SEAL IS BROKEN. Guaifenesin Syrup and Dextromethorphan is a red, cherry flavored syrup and is available in the following dosage forms: 5 mL unit-dose cups: 100 cups (10 x 10) NDC 60687-817-17 10 mL unit-dose cups: 100 cups (10 x 10) NDC 60687-828-56"],"package_label_principal_display_panel":["Package/Label Principal Display Panel - Label Case NDC 60687-828-56/Cup NDC 60687-828-42 GUAIFENESIN and DEXTROMETHORPHAN SYRUP Expectorant/Cough Suppressant 200 mg/20 mg per 10 mL Non-Narcotic, Alcohol Free Cherry Flavor Usual Dosage: See attached Drug Facts. Store at 20° to 25°C (68° to 77°F) [See USP] Protect from light. FOR INSTITUTIONAL USE ONLY T0638C100324 R03/24 GUAIFENESIN and DEXTROMETHORPHAN SYRUP Label","Package/Label Principal Display Panel – Cup Lid – 200 mg/20 mg per 10 mL NDC 60687- 828 -42 Guaifenesin and Dextromethorphan Syrup Expectorant/cough Suppressant 200 mg/20 mg per 10 mL Sodium Content: 8 mg/10 mL Delivers 10 mL Protect from light See package Drug Facts insert for full prescribing information and storage For Institutional Use Only. American Health Packaging Columbus, OH 43217 F0638C100224 GUAIFENESIN and DEXTROMETHORPHAN SYRUP Cup Lid"],"pregnancy_or_breast_feeding":["If pregnant or breast-feeding, ask a health professional before use."],"purpose":["Purpose Expectorant Cough Suppressant"],"questions":["Questions or comments? Call 1-800-845-8210"],"set_id":"8632a655-7f5b-450f-95fa-62478a174e9c","spl_product_data_elements":["Guaifenesin DM Guaifenesin and Dextromethorphan ANHYDROUS CITRIC ACID FD&C RED NO. 40 GLYCERIN MENTHOL, UNSPECIFIED FORM WATER SODIUM BENZOATE SODIUM CITRATE, UNSPECIFIED FORM SACCHARIN SODIUM SUCROSE GUAIFENESIN GUAIFENESIN DEXTROMETHORPHAN DEXTROMETHORPHAN DEXTROMETHORPHAN HYDROBROMIDE"],"spl_unclassified_section":["Professional Note: Guaifenesin has been shown to produce a color interference with certain clinical laboratory determinations of 5-hydroxyindoleacetic acid (5-HIAA) and vanillylmandelic acid (VMA). Distributed by: American Health Packaging Columbus, OH 43217 R0324"],"stop_use":["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. you are hypersensitive to any of the ingredients."],"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 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. you are hypersensitive to any of the ingredients. 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."]}