{"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 width=\"40%\"> <col width=\"31%\"/> <col width=\"9%\"/> <tbody> <tr> <td colspan=\"2\" styleCode=\"Toprule \" valign=\"top\"> <paragraph>Each 5 mL (1 teaspoonful) contains:</paragraph> </td> </tr> <tr> <td valign=\"top\"> <paragraph>Guaifenesin</paragraph> </td> <td valign=\"top\"> <paragraph>100 mg</paragraph> </td> </tr> <tr> <td styleCode=\"Botrule \" valign=\"top\"> <paragraph>Dextromethorphan Hydrobromide</paragraph> </td> <td styleCode=\"Botrule \" valign=\"top\"> <paragraph>10 mg</paragraph> </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 (½ teaspoonful) every 4 hours children under 2 years ask a doctor"],"dosage_and_administration_table":["<table width=\"75%\"> <col width=\"37%\"/> <col width=\"38%\"/> <thead> <tr> <th align=\"left\" styleCode=\"Rrule Botrule Lrule Toprule \" valign=\"top\"> <content styleCode=\"bold\">age</content> </th> <th align=\"left\" styleCode=\"Rrule Botrule Toprule \" valign=\"top\"> <content styleCode=\"bold\">dose</content> </th> </tr> </thead> <tbody> <tr> <td styleCode=\"Rrule Lrule Toprule Botrule \" valign=\"top\"> <paragraph>adults and children 12 years and over</paragraph> </td> <td styleCode=\"Rrule Toprule Botrule \" valign=\"top\"> <paragraph>10 mL (2 teaspoonfuls) every 4 hours</paragraph> </td> </tr> <tr> <td styleCode=\"Rrule Lrule Botrule \" valign=\"top\"> <paragraph>children 6 years to under 12 years</paragraph> </td> <td styleCode=\"Rrule Botrule \" valign=\"top\"> <paragraph>5 mL (1 teaspoonful) every 4 hours</paragraph> </td> </tr> <tr> <td styleCode=\"Rrule Lrule Botrule \" valign=\"top\"> <paragraph>children 2 years to under 6 years</paragraph> </td> <td styleCode=\"Rrule Botrule \" valign=\"top\"> <paragraph>2.5 mL (&#xBD; teaspoonful) every 4 hours</paragraph> </td> </tr> <tr> <td styleCode=\"Rrule Botrule Lrule \" valign=\"top\"> <paragraph>children under 2 years</paragraph> </td> <td styleCode=\"Rrule Botrule \" valign=\"top\"> <paragraph>ask a doctor</paragraph> </td> </tr> </tbody> </table>"],"effective_time":"20180702","id":"8eb2a6ca-68cf-4485-ad36-c29502ee7025","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":["Principal Display Panel Guaifenesin Syrup and Dextromethorphan 200 mg/20 mg per 10 mL 5 Unit Dose Cups 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":"50d43743-40a3-49f7-8eb7-c8e1f7ff0e70","spl_product_data_elements":["Guaifenesin and Dextromethorphan Guaifenesin and Dextromethorphan GUAIFENESIN GUAIFENESIN DEXTROMETHORPHAN DEXTROMETHORPHAN DEXTROMETHORPHAN HYDROBROMIDE CITRIC ACID MONOHYDRATE 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: NDC 0121-0638-04 (4 fl oz bottle), NDC 0121-0638-08 (8 fl oz bottle), NDC 0121-0638-16 (16 fl oz bottle), NDC 0121-0638-05 (unit dose cups of 5 mL, 10 × 10's), and NDC 0121-0638-10 (unit dose cups of 10 mL, 10 × 10's)."],"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. R 06/06 Pharmaceutical Associates, Inc. Greenville, SC 29605"],"version":"3","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."]}