{"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 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 yearsask a doctor
"],"effective_time":"20241111","how_supplied":["HOW SUPPLIED: Guaifenesin Syrup and Dextromethorphan is a red, cherry flavored syrup supplied in the following oral dosage forms: NDC 0121-0638-04: 4 fl oz (118 mL) bottle NDC 0121-0638-08: 8 fl oz (237 mL) bottle NDC 0121-0638-16: 16 fl oz (473 mL) bottle NDC 0121­0638-05: 5 mL unit dose cup NDC 0121-0638-00: Case contains 100 unit dose cups of 5 mL (0121-0638-05) packaged in 10 trays of 10 unit dose cups each. NDC 0121-1276-10: 10 mL unit dose cup NDC 0121-1276-00: Case contains 100 unit dose cups of 10 mL (0121-1276-10) packaged in 10 trays of 10 unit dose cups each."],"id":"c50b4c5c-6f55-4118-a282-e0b490704e49","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"],"is_original_packager":[true],"manufacturer_name":["PAI Holdings, LLC dba PAI Pharma"],"nui":["N0000181821","N0000182149","N0000181819","N0000182147","N0000193956","N0000008867","N0000009560"],"package_ndc":["0121-0638-05","0121-0638-00","0121-0638-04","0121-0638-08","0121-0638-16","0121-1276-10","0121-1276-00"],"pharm_class_epc":["Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC]","Sigma-1 Agonist [EPC]","Expectorant [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":["0121-0638","0121-1276"],"product_type":["HUMAN OTC DRUG"],"route":["ORAL"],"rxcui":["996520"],"spl_id":["c50b4c5c-6f55-4118-a282-e0b490704e49"],"spl_set_id":["ff970fff-d1a3-4322-83b4-34e361431a1c"],"substance_name":["GUAIFENESIN","DEXTROMETHORPHAN"],"unii":["7355X3ROTS","495W7451VQ"],"upc":["0301210638046","0301210638169"]},"package_label_principal_display_panel":["PRINCIPAL DISPLAY PANEL - 5 mL Unit Dose Cup Label Delivers 5 mL NDC 0121-0638-05 GUAIFENESIN SYRUP and DEXTROMETHORPHAN 100 mg/10 mg per 5 mL Package Not Child-Resistant PHARMACEUTICAL ASSOCIATES, INC. GREENVILLE, SC 29605 SEE INSERT 5 mL unit dose cup label","PRINCIPAL DISPLAY PANEL - 118 mL Bottle Label NDC 0121-0638-04 NSN 6505-01-318-1565 Quality ® Value Guaifenesin-DM 100 mg/10 mg per 5 mL EXPECTORANT/COUGH SUPPRESSANT Compare to the active ingredients in *Robitussin ®- DM CONTROLS COUGHS LOOSENS AND RELIEVES CHEST CONGESTION 4 fl oz (118 mL) Pharmaceutical Associates, Inc. Greenville, SC 29605 118 mL bottle label","PRINCIPAL DISPLAY PANEL - 237 mL Bottle Label NDC 0121-0638-08 Quality ® Value Guaifenesin-DM 100 mg/10 mg per 5 mL EXPECTORANT/COUGH SUPPRESSANT Compare to the active ingredients in *Robitussin ®- DM CONTROLS COUGHS LOOSENS AND RELIEVES CHEST CONGESTION 8 fl oz (237 mL) Pharmaceutical Associates, Inc. Greenville, SC 29605 237 mL bottle label","PRINCIPAL DISPLAY PANEL - 473 mL Bottle Label NDC 0121-0638-16 Quality ® Value Guaifenesin-DM 100 mg/10 mg per 5 mL EXPECTORANT/COUGH SUPPRESSANT Compare to the active ingredients in *Robitussin ®- DM CONTROLS COUGHS LOOSENS AND RELIEVES CHEST CONGESTION 16 fl oz (473 mL) Pharmaceutical Associates, Inc. Greenville, SC 29605 473 mL bottle label","PRINCIPAL DISPLAY PANEL - 10 mL Unit Dose Cup Label Delivers 10 mL NDC 0121-1276-10 GUAIFENESIN SYRUP and DEXTROMETHORPHAN 200 mg/20 mg per 10 mL Package Not Child-Resistant PHARMACEUTICAL ASSOCIATES, INC. GREENVILLE, SC 29605 SEE INSERT 10 unit dose cup 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":"ff970fff-d1a3-4322-83b4-34e361431a1c","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 WATER SODIUM BENZOATE SODIUM CITRATE SACCHARIN SODIUM SUCROSE GUAIFENESIN DM GUAIFENESIN and DEXTROMETHORPHAN GUAIFENESIN GUAIFENESIN DEXTROMETHORPHAN DEXTROMETHORPHAN DEXTROMETHORPHAN HYDROBROMIDE SODIUM BENZOATE SODIUM CITRATE SACCHARIN SODIUM SUCROSE ANHYDROUS CITRIC ACID FD&C RED NO. 40 GLYCERIN MENTHOL WATER"],"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).","MANUFACTURED BY Pharmaceutical Associates, Inc. Greenville, SC 29605 www.paipharma.com 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."]}