{"active_ingredient":["Active ingredients (in each 20 mL) Dextromethorphan HBr, USP 20 mg Guaifenesin, USP 200 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 child's prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product."],"dosage_and_administration":["Directions ▪ do not take more than 6 doses in any 24-hour period ▪ measure only with dosing cup provided ▪ keep dosing cup with product ▪ mL = milliliter Age Dose children under 4 years do not use children 4 to under 6 years 5 mL every 4 hours children 6 to under 12 years 10 mL every 4 hours adults and children 12 years and older 20 mL every 4 hours"],"dosage_and_administration_table":["<table cellpadding=\"0pt\" cellspacing=\"0pt\" width=\"100%\"><col width=\"49%\"/><col width=\"49%\"/><tbody><tr><td align=\"center\" styleCode=\"Rrule Botrule Lrule Toprule \" valign=\"middle\"><paragraph> <content styleCode=\"bold\">Age</content></paragraph></td><td align=\"center\" styleCode=\"Rrule Botrule Toprule \" valign=\"middle\"><paragraph><content styleCode=\"bold\">Dose</content></paragraph></td></tr><tr><td align=\"center\" styleCode=\"Rrule Lrule Botrule \" valign=\"middle\"><paragraph>children under 4 years</paragraph></td><td align=\"center\" styleCode=\"Rrule Botrule \" valign=\"middle\"><paragraph>do not use</paragraph></td></tr><tr><td align=\"center\" styleCode=\"Rrule Lrule Botrule \" valign=\"middle\"><paragraph>children 4 to under 6 years</paragraph></td><td align=\"center\" styleCode=\"Rrule Botrule \" valign=\"middle\"><paragraph>5 mL every 4 hours</paragraph></td></tr><tr><td align=\"center\" styleCode=\"Rrule Lrule Botrule \" valign=\"middle\"><paragraph>children 6 to under 12 years</paragraph></td><td align=\"center\" styleCode=\"Rrule Botrule \" valign=\"middle\"><paragraph>10 mL every 4 hours</paragraph></td></tr><tr><td align=\"center\" styleCode=\"Rrule Botrule Lrule \" valign=\"top\"><paragraph>adults and children 12 years and older</paragraph></td><td align=\"center\" styleCode=\"Rrule Botrule \" valign=\"middle\"><paragraph>20 mL every 4 hours</paragraph></td></tr></tbody></table>"],"effective_time":"20260909","id":"c410d669-35bc-4ceb-a613-c9b2a34b5aa0","inactive_ingredient":["Inactive ingredients anhydrous citric acid, carboxymethylcellulose sodium, edetate disodium, glycerin, flavor, propylene glycol, purified water, sodium benzoate, sodium citrate, sorbitol solution, sucralose, xanthan gum."],"indications_and_usage":["Uses ▪ temporarily relieves cough due to minor throat and bronchial irritation as may occur with a cold ▪ helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes"],"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 at 1-800-222-1222."],"openfda":{"application_number":["M012"],"brand_name":["DRx Choice Children daytime Cough and Chest Congestion"],"generic_name":["DEXTROMETHORPHAN HBR AND GUAIFENESIN"],"is_original_packager":[true],"manufacturer_name":["RARITAN PHARMACEUTICALS"],"nui":["N0000193956","N0000008867","N0000009560"],"package_ndc":["68163-747-04"],"pharm_class_epc":["Expectorant [EPC]"],"pharm_class_pe":["Decreased Respiratory Secretion Viscosity [PE]","Increased Respiratory Secretions [PE]"],"product_ndc":["68163-747"],"product_type":["HUMAN OTC DRUG"],"route":["ORAL"],"rxcui":["1790650"],"spl_id":["c410d669-35bc-4ceb-a613-c9b2a34b5aa0"],"spl_set_id":["25fff2a6-ecb1-4117-bd11-e5ec3e3d09a9"],"substance_name":["DEXTROMETHORPHAN HYDROBROMIDE","GUAIFENESIN"],"unii":["9D2RTI9KYH","495W7451VQ"]},"package_label_principal_display_panel":["PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 4 FL OZ (118 mL Bottle) Compare to the active ingredients in Children's Robitussin ® Cough & Chest Congestion DM * NDC 68163-747-04 DRx Choice® Children's daytime cough & chest congestion Dextromethorphan HBr (Cough Suppressant) Guaifenesin ( Expectorant) Relieves: Chest congestion, mucus & cough Sugar Free Dye Free No Added Alcohol For Ages 4 & Over Grape Flavor Naturally & Artificially Flavored 4 FL OZ (118 mL) TAMPER-EVIDENT: DO NOT USE IF PRINTED INNER SEAL UNDER CAP IS TORN OR MISSING IMPORTANT: KEEP THIS CARTON FOR FUTURE REFERENCE ON FULL LABELING * This product is not manufactured or distributed by Pfizer, owner of the registered trademarks Children’s Robitussin ® Cough & Chest Congestion DM. Manufactured by: Raritan Pharmaceuticals 8 Joanna Court, East Brunswick, NJ, 08816 DRx Choice Children's daytime Cough & Chest Congestion"],"package_label_principal_display_panel_table":["<table styleCode=\"Noautorules\" width=\"100%\"><col width=\"100%\"/><tbody><tr><td styleCode=\"Rrule Botrule Lrule Toprule \" valign=\"top\"><paragraph>TAMPER-EVIDENT: DO NOT USE IF PRINTED INNER SEAL UNDER CAP IS TORN OR MISSING</paragraph></td></tr></tbody></table>","<table styleCode=\"Noautorules\" width=\"100%\"><col width=\"100%\"/><tbody><tr><td styleCode=\"Rrule Botrule Lrule Toprule \" valign=\"top\"><paragraph>IMPORTANT: KEEP THIS CARTON FOR FUTURE REFERENCE ON FULL LABELING</paragraph></td></tr></tbody></table>"],"pregnancy_or_breast_feeding":["If pregnant or breast-feeding, ask a health professional before use."],"purpose":["Purposes Cough suppressant Expectorant"],"questions":["Questions or Comments 1-866-467-2748"],"set_id":"25fff2a6-ecb1-4117-bd11-e5ec3e3d09a9","spl_product_data_elements":["DRx Choice Children daytime Cough and Chest Congestion Dextromethorphan HBr and Guaifenesin DEXTROMETHORPHAN HYDROBROMIDE DEXTROMETHORPHAN GUAIFENESIN GUAIFENESIN ANHYDROUS CITRIC ACID CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED EDETATE DISODIUM GLYCERIN PROPYLENE GLYCOL WATER SODIUM BENZOATE SODIUM CITRATE, UNSPECIFIED FORM SORBITOL SUCRALOSE XANTHAN GUM"],"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."],"storage_and_handling":["Other information ▪ each 20 ml contains: sodium 10 mg ▪ store at room temperature. Do not refrigerate."],"version":"4","warnings":["Warnings"]}