{"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":["<table styleCode=\"Noautorules\" width=\"40%\"> <col align=\"left\" valign=\"top\" width=\"80%\"/> <col align=\"right\" valign=\"top\" width=\"20%\"/> <tbody> <tr> <td align=\"left\" colspan=\"2\">Each 5 mL (1 teaspoonful) contains:</td> </tr> <tr> <td>Guaifenesin</td> <td>100 mg</td> </tr> <tr> <td>Dextromethorphan Hydrobromide</td> <td>10 mg</td> </tr> </tbody> </table>"],"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":["<table width=\"75%\"> <col align=\"center\" valign=\"top\" width=\"50%\"/> <col align=\"center\" valign=\"top\" width=\"50%\"/> <thead> <tr styleCode=\"First Last\"> <th align=\"center\" styleCode=\"Lrule Rrule\">age</th> <th align=\"center\" styleCode=\"Rrule\">dose</th> </tr> </thead> <tbody> <tr styleCode=\"Botrule First\"> <td align=\"center\" styleCode=\"Lrule Rrule\">adults and children  12 years and over </td> <td align=\"center\" styleCode=\"Rrule\">10 mL (2 teaspoonfuls)  every 4 hours </td> </tr> <tr styleCode=\"Botrule\"> <td align=\"center\" styleCode=\"Lrule Rrule\">children 6 years to  under 12 years </td> <td align=\"center\" styleCode=\"Rrule\">5 mL (1 teaspoonful)  every 4 hours </td> </tr> <tr styleCode=\"Botrule\"> <td align=\"center\" styleCode=\"Lrule Rrule\">children 2 years to  under 6 years </td> <td align=\"center\" styleCode=\"Rrule\">2.5 mL (1/2 teaspoonful)  every 4 hours </td> </tr> <tr> <td align=\"center\" styleCode=\"Lrule Rrule\">children under 2 years</td> <td align=\"center\" styleCode=\"Rrule\">ask a doctor</td> </tr> </tbody> </table>"],"effective_time":"20180621","how_supplied":["Product: 50090-3492 NDC: 50090-3492-0 10 mL in a CUP, UNIT-DOSE / 100 in a CASE"],"id":"487a929f-b905-42e5-8ded-cde745bfa370","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":{},"package_label_principal_display_panel":["GUAIFENESIN and DEXTROMETHORPHAN Label Image"],"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":"765e1568-2531-4731-a5e9-d1eea324cf16","spl_product_data_elements":["GUAIFENESIN DM GUAIFENESIN and DEXTROMETHORPHAN SODIUM BENZOATE SODIUM CITRATE, UNSPECIFIED FORM SACCHARIN SODIUM SUCROSE GUAIFENESIN GUAIFENESIN DEXTROMETHORPHAN DEXTROMETHORPHAN DEXTROMETHORPHAN HYDROBROMIDE CITRIC ACID MONOHYDRATE FD&C RED NO. 40 GLYCERIN MENTHOL, UNSPECIFIED FORM 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":"9","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."]}