{"active_ingredient":["DESCRIPTION Each 5 mL (1 teaspoonful) contains: Guaifenesin 100 mg Dextromethorphan Hydrobromide 10 mg Inactive Ingredients: Citric acid, FD&C Red No. 40, flavoring, glycerin, menthol, purified water, sodium benzoate, sodium citrate, sodium saccharin, and sucrose. Sodium Content: 4 mg/5 mL"],"active_ingredient_table":["
Each 5 mL (1 teaspoonful) contains:
Guaifenesin100 mg
Dextromethorphan Hydrobromide10 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: Follow dosage below or use as directed by a physician. • do not take more than 6 doses in any 24-hour period. age dose 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 dose
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":"20260512","id":"fc55eac0-ec3d-4788-aa04-e792c52ff620","inactive_ingredient":["Inactive Ingredients: Citric acid, FD&C Red No. 40, flavoring, glycerin, menthol, purified water, sodium benzoate, sodium citrate, sodium saccharin, and sucrose. Sodium Content: 4 mg/5 mL"],"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"],"manufacturer_name":["Cardinal Health 107, LLC"],"nui":["N0000193956","N0000008867","N0000009560","N0000181821","N0000182149","N0000181819","N0000182147"],"original_packager_product_ndc":["0121-0638"],"package_ndc":["55154-5785-5"],"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":["55154-5785"],"product_type":["HUMAN OTC DRUG"],"route":["ORAL"],"rxcui":["996520"],"spl_id":["fc55eac0-ec3d-4788-aa04-e792c52ff620"],"spl_set_id":["9cfb1abb-98c4-4e90-8dd7-fcffc112f988"],"substance_name":["GUAIFENESIN","DEXTROMETHORPHAN"],"unii":["495W7451VQ","7355X3ROTS"],"upc":["0055154578554"]},"package_label_principal_display_panel":["Principal Display Panel NDC 55154-5785-5 GUAIFENESIN SYRUP AND DEXTROMETHORPHAN 100 mg/10 mg per 5 mL 5 CUPS 100mg/10mg per 5mL bag label"],"pregnancy_or_breast_feeding":["If pregnant or breast-feeding, ask a health professional before use."],"purpose":["Non-Narcotic, Alcohol Free Expectorant/Cough Suppressant"],"set_id":"9cfb1abb-98c4-4e90-8dd7-fcffc112f988","spl_product_data_elements":["GUAIFENESIN DM GUAIFENESIN and DEXTROMETHORPHAN GUAIFENESIN GUAIFENESIN DEXTROMETHORPHAN DEXTROMETHORPHAN DEXTROMETHORPHAN HYDROBROMIDE ANHYDROUS CITRIC ACID FD&C RED NO. 40 GLYCERIN MENTHOL, UNSPECIFIED FORM WATER SODIUM BENZOATE SODIUM CITRATE, UNSPECIFIED FORM SACCHARIN SODIUM SUCROSE"],"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).","HOW SUPPLIED: Guaifenesin Syrup and Dextromethorphan is a red, cherry flavored syrup supplied in the following oral dosage forms: Overbagged with 5 x 5 mL unit dose cups in each bag, NDC 55154-5785-5 WARNING: This Unit Dose package is not child resistant and is Intended for Institutional Use Only. Keep this and all drugs out of the reach of children.","MANUFACTURED BY Pharmaceutical Associates, Inc. Greenville, SC 29605 www.paipharma.com Distributed By: Cardinal Health Dublin, OH 43017 L54670891225 R11/16"],"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."],"storage_and_handling":["STORAGE: Keep tightly closed. Store at controlled room temperature, 20°-25°C (68°-77°F) [See USP]. Protect from light."],"version":"8","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."]}