{"active_ingredient":["DESCRIPTION Each 5 mL (1 teaspoonful) contains: Guaifenesin 100 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 dose adults and children 12 years and over 10 to 20 mL (2 to 4 teaspoonfuls) every 4 hours children 6 years to under 12 years 5 to 10 mL (1 to 2 teaspoonfuls) every 4 hours children 2 to under 6 years of age 2.5 to 5 mL (½ to 1 teaspoonful) every 4 hours children under 2 years of age consult a physician"],"dosage_and_administration_table":["
age dose
adults and children 12 years and over10 to 20 mL (2 to 4 teaspoonfuls) every 4 hours
children 6 years to under 12 years5 to 10 mL (1 to 2 teaspoonfuls) every 4 hours
children 2 to under 6 years of age2.5 to 5 mL (½ to 1 teaspoonful) every 4 hours
children under 2 years of ageconsult a physician
"],"effective_time":"20220614","how_supplied":["Guaifenesin Oral Solution USP is a red, raspberry flavored solution supplied in the following oral dosage forms: NDC 0121-0744-04: 4 fl oz (120 mL) bottle NDC 0121-0744-08: 8 fl oz (237 mL) bottle NDC 0121-0744-16: 16 fl oz (473 mL) bottle NDC 0121-1744-05: 5 mL unit dose cup NDC 0121-1744-00: Case contains 100 unit dose cups of 5 mL (0121-1744-05) packaged in 10 trays of 10 unit dose cups each. NDC 0121-1488-10: 10 mL unit dose cup NDC 0121-1488-00: Case contains 100 unit dose cups of 10 mL (0121-1488-10) packaged in 10 trays of 10 unit dose cups each. NDC 0121-2232-15: 15 mL unit dose cup NDC 0121-2232-00: Case contains 100 unit dose cups of 15 mL (0121-2232-15) packaged in 10 trays of 10 unit dose cups each."],"id":"25a970c7-0016-4f22-9e94-1e20e1319e3e","inactive_ingredient":["Inactive Ingredients Acesulfame K, citric acid, FD&C Green No. 3, FD&C Red No. 40, flavoring, hydroxyethylcellulose, purified water, sodium benzoate and sodium citrate. Sodium Content: 4 mg/5 mL"],"indications_and_usage":["USES Helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive."],"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"],"generic_name":["GUAIFENESIN"],"is_original_packager":[true],"manufacturer_name":["PAI Holdings, LLC dba PAI Pharma"],"nui":["N0000193956","N0000008867","N0000009560"],"package_ndc":["0121-0744-04","0121-0744-08","0121-0744-16","0121-1744-05","0121-1744-00","0121-1488-10","0121-1488-00","0121-2232-15","0121-2232-00"],"pharm_class_epc":["Expectorant [EPC]"],"pharm_class_pe":["Decreased Respiratory Secretion Viscosity [PE]","Increased Respiratory Secretions [PE]"],"product_ndc":["0121-0744","0121-1744","0121-1488","0121-2232"],"product_type":["HUMAN OTC DRUG"],"route":["ORAL"],"rxcui":["310604"],"spl_id":["25a970c7-0016-4f22-9e94-1e20e1319e3e"],"spl_set_id":["c2e53fb5-2798-47c8-9285-d1077d46e629"],"substance_name":["GUAIFENESIN"],"unii":["495W7451VQ"]},"package_label_principal_display_panel":["PRINCIPAL DISPLAY PANEL - 473 mL Bottle Label NDC 0121-0744-16 Quality ® Value Guaifenesin Oral Solution USP 100 mg/5 mL EXPECTORANT Compare to the active ingredient in *Robitussin® SUGAR FREE/ALCOHOL FREE LOOSENS AND RELIEVES CHEST CONGESTION 16 fl oz (473 mL) Pharmaceutical Associates, Inc. Greenville, SC 29605 PRINCIPAL DISPLAY PANEL - 473 mL Bottle Label","PRINCIPAL DISPLAY PANEL - 5 mL Cup Label Delivers 5 mL NDC 0121-1744-05 G UAIFENESIN O RAL S OLUTION USP 100 mg/5 mL Sugar Free/Alcohol Free EXPECTORANT Package Not Child-Resistant PHARMACEUTICAL ASSOCIATES, INC. GREENVILLE, SC 29605 SEE INSERT PRINCIPAL DISPLAY PANEL - 5 mL Cup Label","PRINCIPAL DISPLAY PANEL - 10 mL Cup Label Delivers 10 mL NDC 0121-1488-10 G UAIFENESIN O RAL S OLUTION USP 200 mg/10 mL Sugar Free/Alcohol Free EXPECTORANT Package Not Child-Resistant PHARMACEUTICAL ASSOCIATES, INC. GREENVILLE, SC 29605 SEE INSERT PRINCIPAL DISPLAY PANEL - 10 mL Cup Label","PRINCIPAL DISPLAY PANEL - 15 mL Cup Label Delivers 15 mL NDC 0121-2232-15 G UAIFENESIN O RAL S OLUTION USP 300 mg/15 mL Sugar Free/Alcohol Free EXPECTORANT Package Not Child-Resistant PHARMACEUTICAL ASSOCIATES, INC. GREENVILLE, SC 29605 SEE INSERT PRINCIPAL DISPLAY PANEL - 15 mL Cup Label"],"pregnancy_or_breast_feeding":["If pregnant or breast-feeding, ask a health professional before use."],"purpose":["Expectorant SUGAR FREE / ALCOHOL FREE"],"set_id":"c2e53fb5-2798-47c8-9285-d1077d46e629","spl_product_data_elements":["GUAIFENESIN GUAIFENESIN GUAIFENESIN GUAIFENESIN ACESULFAME POTASSIUM FD&C GREEN NO. 3 FD&C RED NO. 40 HYDROXYETHYL CELLULOSE, UNSPECIFIED WATER SODIUM BENZOATE SODIUM CITRATE, UNSPECIFIED FORM ANHYDROUS CITRIC ACID GUAIFENESIN GUAIFENESIN GUAIFENESIN GUAIFENESIN ACESULFAME POTASSIUM FD&C GREEN NO. 3 FD&C RED NO. 40 HYDROXYETHYL CELLULOSE, UNSPECIFIED WATER SODIUM BENZOATE SODIUM CITRATE, UNSPECIFIED FORM ANHYDROUS CITRIC ACID GUAIFENESIN GUAIFENESIN GUAIFENESIN GUAIFENESIN ANHYDROUS CITRIC ACID ACESULFAME POTASSIUM FD&C GREEN NO. 3 FD&C RED NO. 40 HYDROXYETHYL CELLULOSE, UNSPECIFIED WATER SODIUM BENZOATE SODIUM CITRATE, UNSPECIFIED FORM GUAIFENESIN GUAIFENESIN GUAIFENESIN GUAIFENESIN ANHYDROUS CITRIC ACID ACESULFAME POTASSIUM FD&C GREEN NO. 3 FD&C RED NO. 40 HYDROXYETHYL CELLULOSE, UNSPECIFIED WATER SODIUM BENZOATE SODIUM CITRATE, UNSPECIFIED FORM"],"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)."],"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":"9","warnings":["WARNINGS 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."]}