{"active_ingredient":["DRUG FACTS 10 mg-100 mg/5 mL - Active ingredient per 5 mL (1 unit dose) Dextromethorphan HBr. 10 mg Guaifenesin 100 mg 20 mg-200 mg/10 mL - Active ingredient per 10 mL (1 unit dose) Dextromethorphan HBr. 20 mg Guaifenesin 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 20 mg-200 mg/10 mL age dose Children under 12 years of age Do not use Adults and children over 12 years of age 10 mL (1 unit dose) every 4 hours 10 mg-100 mg/5 mL age dose Children under 6 years of age Do not use Children 6 to under 12 years of age 5 mL (1 unit dose) every 4 hours Adults and children over 12 years of age 10 mL (2 unit dose) every 4 hours"],"dosage_and_administration_table":["
agedose
Children under 12 years of ageDo not use
Adults and children over 12 years of age10 mL (1 unit dose) every 4 hours
","
agedose
Children under 6 years of ageDo not use
Children 6 to under 12 years of age5 mL (1 unit dose) every 4 hours
Adults and children over 12 years of age10 mL (2 unit dose) every 4 hours
"],"effective_time":"20250701","how_supplied":["NDC Information - Each 5 mL of Guaifenesin Syrup and Dextromethorphan contains Guaifenesin 100mg and Dextromethorphan Hydrobromide 10mg and is supplied in the following oral dosage forms: NDC 57237-312-05 unit dose cup 5mL NDC 57237-312-51 (100 x 5 mL) unit-dose cups Each 10 mL of Guaifenesin Syrup and Dextromethorphan contains Guaifenesin 200mg and Dextromethorphan Hydrobromide 20mg and is supplied in the following oral dosage forms: NDC 57237-313-01 unit dose cup 10mL NDC 57237-313-18 (80 x 10 mL) unit-dose cups"],"id":"914d13bb-fbd6-420f-ad2c-1df3828d18c3","inactive_ingredient":["Inactive Ingredients citric acid, FD&C red#40, flavor, menthol, methylparaben, propylene glycol, propylparaben, purified water, sodium citrate, and 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 drain bronchial tubes"],"keep_out_of_reach_of_children":["Keep out of reach of children. In case of accidental overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222)"],"openfda":{},"other_safety_information":["Other Information • store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature] • do not use if lid is torn or broken"],"package_label_principal_display_panel":["PACKAGE LABEL.PRINCIPAL DISPLAY PANEL 10 mg-100 mg/5 mL Lid Label NDC 57237-312-05 Case Label NDC 57237-312-51 20 mg-200 mg/10 mL Lid Label NDC 57237-313-01 Case Label NDC 57237-313-18 Guai-Dextro-lid-label-5ml Guai-Dextro-case-label-5ml Guai-Dextro-lid-label-10ml Guai-Dextro-case-label-10ml"],"pregnancy_or_breast_feeding":["If pregnant or breast-feeding, ask a healthcare professional before use."],"purpose":["Purpose Cough Suppressant Expectorant"],"questions":["Questions or comments? Call 1-844-474-7464 Distributed by: Rising Pharma Holdings, Inc. East Brunswick, NJ 08816 Issued: 04/2023"],"set_id":"e463e60f-d0db-4ee7-9713-ddf25aa38a43","spl_product_data_elements":["Dextromethorphan HBr. and Guaifenesin Dextromethorphan HBr. and Guaifenesin DEXTROMETHORPHAN HYDROBROMIDE DEXTROMETHORPHAN GUAIFENESIN GUAIFENESIN ANHYDROUS CITRIC ACID FD&C RED NO. 4 MENTHOL METHYLPARABEN PROPYLENE GLYCOL PROPYLPARABEN WATER SODIUM CITRATE SUCRALOSE Dextromethorphan HBr. and Guaifenesin Dextromethorphan HBr. and Guaifenesin DEXTROMETHORPHAN HYDROBROMIDE DEXTROMETHORPHAN GUAIFENESIN GUAIFENESIN ANHYDROUS CITRIC ACID FD&C RED NO. 4 MENTHOL METHYLPARABEN PROPYLENE GLYCOL PROPYLPARABEN WATER SODIUM CITRATE SUCRALOSE"],"stop_use":["Stop use and ask a doctor if cough lasts more than 7 days, comes back, or is accompanied by fever, rash, or persistant headache. These could be signs 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 more than 7 days, comes back, or is accompanied by fever, rash, or persistant headache. These could be signs of a serious condition. If pregnant or breast-feeding, ask a healthcare professional before use. Keep out of reach of children. In case of accidental overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222)"]}