{"active_ingredient":["Active ingredients (in each 20 mL) Dextromethorphan HBr, USP 20 mg Guaifenesin, USP 200 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"],"do_not_use":["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."],"dosage_and_administration":["Directions • do not take more than 6 doses in any 24-hour period • measure only with dosing cup provided • keep dosing cup with product • mL = milliliter • this adult product is not intended for use in children under 12 years of age age dose adults and children 12 years and over 20 mL every 4 hours children under 12 years do not use"],"dosage_and_administration_table":["
agedose
adults and children 12 years and over20 mL every 4 hours
children under 12 yearsdo not use
"],"effective_time":"20260826","id":"ec855832-654a-4cc0-b8a0-3e6fa0f3fab4","inactive_ingredient":["Inactive ingredients anhydrous citric acid, FD&C red no. 40, flavor, glycerin, propylene glycol, purified water, sodium benzoate, sodium citrate, sorbitol solution, sucralose, xanthan gum"],"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 drain bronchial tubes"],"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 (1-800-222-1222)."],"openfda":{"application_number":["part341"],"brand_name":["robafen dm"],"generic_name":["DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN"],"manufacturer_name":["Preferred Pharmaceuticals Inc."],"nui":["N0000193956","N0000008867","N0000009560"],"original_packager_product_ndc":["0904-7223"],"package_ndc":["68788-8268-1"],"pharm_class_epc":["Expectorant [EPC]"],"pharm_class_pe":["Decreased Respiratory Secretion Viscosity [PE]","Increased Respiratory Secretions [PE]"],"product_ndc":["68788-8268"],"product_type":["HUMAN OTC DRUG"],"route":["ORAL"],"rxcui":["1790650"],"spl_id":["ec855832-654a-4cc0-b8a0-3e6fa0f3fab4"],"spl_set_id":["5b2fd5ce-56ab-491a-81b9-44e35a5d2316"],"substance_name":["DEXTROMETHORPHAN HYDROBROMIDE","GUAIFENESIN"],"unii":["9D2RTI9KYH","495W7451VQ"]},"other_safety_information":["Other information • each 20 mL contains: sodium 14 mg • store at 20-25°C (68-77°F). Do not refrigerate."],"package_label_principal_display_panel":["Package/Label Principal Display Panel MAJOR ® Relabeled By: Preferred Pharmaceuticals Inc. Compare to Robitussin ® Cough + Chest Congestion DM active ingredients Robafen ® DM Cough and Chest Congestion Dextromethorphan HBr, USP 20 mg Guaifenesin, USP 200 mg Cough Suppressant Expectorant Controls Cough Relieves Chest Congestion Thins and Loosens Mucus SEE NEW DOSING Raspberry Flavor Non-Drowsy For Adults Ages 12 and Over 4 FL. OZ. (118 mL) Robafen DM Cough Chest Congestion"],"pregnancy_or_breast_feeding":["If pregnant or breast-feeding, ask a health professional before use."],"purpose":["Purposes Cough suppressant Expectorant"],"questions":["Questions or comments? 1-800-616-2471"],"set_id":"5b2fd5ce-56ab-491a-81b9-44e35a5d2316","spl_product_data_elements":["robafen dm dextromethorphan hydrobromide, guaifenesin DEXTROMETHORPHAN HYDROBROMIDE DEXTROMETHORPHAN GUAIFENESIN GUAIFENESIN ANHYDROUS CITRIC ACID FD&C RED NO. 40 GLYCERIN PROPYLENE GLYCOL WATER SODIUM BENZOATE SODIUM CITRATE, UNSPECIFIED FORM SORBITOL SUCRALOSE XANTHAN GUM"],"stop_use":["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. A persistent cough may be a sign of a serious condition."],"version":"5","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 for more than 7 days, comes back, or is accompanied by fever, rash, or persistent headache. A persistent cough may be a sign 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 (1-800-222-1222)."]}