{"active_ingredient":["Active ingredients (in each 5 mL) Purpose Dextromethorphan HBr 5 mg Cough suppressant Guaifenesin 100 mg Expectorant"],"active_ingredient_table":["<table width=\"70%\"><col width=\"42%\"/><col width=\"28%\"/><tbody><tr><td styleCode=\"Toprule \" valign=\"top\"><paragraph><content styleCode=\"bold\"><content styleCode=\"italics\">Active ingredients (in each 5 mL)</content></content></paragraph></td><td styleCode=\"Toprule \" valign=\"top\"><paragraph><content styleCode=\"bold\"><content styleCode=\"italics\">Purpose</content></content></paragraph></td></tr><tr><td valign=\"top\"><paragraph>Dextromethorphan HBr 5 mg</paragraph></td><td valign=\"top\"><paragraph>Cough suppressant</paragraph></td></tr><tr><td styleCode=\"Botrule \" valign=\"top\"><paragraph>Guaifenesin 100 mg</paragraph></td><td styleCode=\"Botrule \" valign=\"top\"><paragraph>Expectorant</paragraph></td></tr></tbody></table>"],"ask_doctor":["Ask a doctor before use if the child has • cough that occurs with too much phlegm (mucus) • persistent or chronic cough such as occurs with asthma"],"do_not_use":["Do not use in a child who is 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 giving this product."],"dosage_and_administration":["Directions • do not take more than 6 doses in any 24-hour period • measure only with dosing cup provided • do not use dosing cup with other products • dose as follows or as directed by a doctor Age Dose children 6 years to under 12 years 5 mL – 10 mL every 4 hours children 4 years to under 6 years 2.5 mL – 5 mL every 4 hours children under 4 years do not use"],"dosage_and_administration_table":["<table width=\"70%\"><col width=\"36%\"/><col width=\"35%\"/><thead><tr><th align=\"center\" styleCode=\"Rrule Botrule Lrule Toprule \" valign=\"top\"><content styleCode=\"bold\">Age</content></th><th align=\"center\" 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>children 6 years to under 12 years</paragraph></td><td styleCode=\"Rrule Toprule Botrule \" valign=\"top\"><paragraph>5 mL &#x2013; 10 mL every 4 hours</paragraph></td></tr><tr><td styleCode=\"Rrule Lrule Botrule \" valign=\"top\"><paragraph>children 4 years to under 6 years</paragraph></td><td styleCode=\"Rrule Botrule \" valign=\"top\"><paragraph>2.5 mL &#x2013; 5 mL every 4 hours</paragraph></td></tr><tr><td styleCode=\"Rrule Botrule Lrule \" valign=\"top\"><paragraph>children under 4 years</paragraph></td><td styleCode=\"Rrule Botrule \" valign=\"top\"><paragraph>do not use</paragraph></td></tr></tbody></table>"],"effective_time":"20260819","id":"4ce33b05-0044-4e78-9d09-bfe66c3b79e5","inactive_ingredient":["Inactive ingredients anhydrous citric acid, edetate disodium, FD&C red #40, flavors, potassium citrate, propylene glycol, purified water, sodium benzoate, sorbitol, sucralose, xanthan gum"],"indications_and_usage":["Uses • helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive • temporarily relieves: • cough due to minor throat and bronchial irritation as may occur with the common cold or inhaled irritants • the intensity of coughing • the impulse to cough to help your child get to sleep"],"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":["CVS Childrens Cough Relief"],"generic_name":["DEXTROMETHORPHAN HYDROBROMIDE AND GUAIFENESIN"],"is_original_packager":[true],"manufacturer_name":["CVS PHARMACY, INC"],"nui":["N0000193956","N0000008867","N0000009560"],"package_ndc":["69842-577-04"],"pharm_class_epc":["Expectorant [EPC]"],"pharm_class_pe":["Decreased Respiratory Secretion Viscosity [PE]","Increased Respiratory Secretions [PE]"],"product_ndc":["69842-577"],"product_type":["HUMAN OTC DRUG"],"route":["ORAL"],"rxcui":["1020138"],"spl_id":["4ce33b05-0044-4e78-9d09-bfe66c3b79e5"],"spl_set_id":["fe12f3bd-3237-42d1-aec5-c831b9637175"],"substance_name":["DEXTROMETHORPHAN HYDROBROMIDE","GUAIFENESIN"],"unii":["9D2RTI9KYH","495W7451VQ"]},"package_label_principal_display_panel":["PRINCIPAL DISPLAY PANEL - 118 mL Bottle Carton Compare to the Active Ingredients in Children’s Mucinex ® cough NDC 69842-577-04 Children's Cough Relief Dextromethorphan HBr , 5 mg Guaifenesin,100 mg Natural Cherry F lavor Dosage Cup Included Ages 4 + years Controls Cough Relieves Chest Congestion Breaks up Mucus 4 FL OZ (118 mL) *This product is not manufactured or distributed by RB Health (USA), distributor of Children’s Mucinex ® Cough. IMPORTANT: Keep this carton for future reference on full labeling. Children's Mucus and Cough Relief 4 FL OZ Cherry Flavor"],"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> IMPORTANT: Keep this carton for future reference on full labeling.</paragraph></td></tr></tbody></table>"],"purpose":["Active ingredients (in each 5 mL) Purpose Dextromethorphan HBr 5 mg Cough suppressant Guaifenesin 100 mg Expectorant"],"purpose_table":["<table width=\"70%\"><col width=\"42%\"/><col width=\"28%\"/><tbody><tr><td styleCode=\"Toprule \" valign=\"top\"><paragraph><content styleCode=\"bold\"><content styleCode=\"italics\">Active ingredients (in each 5 mL)</content></content></paragraph></td><td styleCode=\"Toprule \" valign=\"top\"><paragraph><content styleCode=\"bold\"><content styleCode=\"italics\">Purpose</content></content></paragraph></td></tr><tr><td valign=\"top\"><paragraph>Dextromethorphan HBr 5 mg</paragraph></td><td valign=\"top\"><paragraph>Cough suppressant</paragraph></td></tr><tr><td styleCode=\"Botrule \" valign=\"top\"><paragraph>Guaifenesin 100 mg</paragraph></td><td styleCode=\"Botrule \" valign=\"top\"><paragraph>Expectorant</paragraph></td></tr></tbody></table>"],"questions":["Questions or comments? 1-866-467-2748"],"set_id":"fe12f3bd-3237-42d1-aec5-c831b9637175","spl_product_data_elements":["CVS Childrens Cough Relief DEXTROMETHORPHAN HYDROBROMIDE AND GUAIFENESIN DEXTROMETHORPHAN HYDROBROMIDE DEXTROMETHORPHAN GUAIFENESIN GUAIFENESIN ANHYDROUS CITRIC ACID EDETATE SODIUM FD&C RED NO. 40 POTASSIUM CITRATE PROPYLENE GLYCOL WATER SODIUM BENZOATE SORBITOL SUCRALOSE XANTHAN GUM"],"spl_unclassified_section":["Drug Facts",""],"stop_use":["Stop use and ask a doctor if cough lasts more than 7 days, comes back, or occurs with fever, rash, or persistent headache. These could be signs of a serious condition."],"storage_and_handling":["Other information • each 5 mL contains : sodium 2 mg • Tamper evident: do not use if printed inner seal under cap is torn or missing • store at room temperature • do not refrigerate"],"version":"6","warnings":["Warnings Do not use in a child who is 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 giving this product. Ask a doctor before use if the child has • cough that occurs with too much phlegm (mucus) • persistent or chronic cough such as occurs with asthma Stop use and ask a doctor if cough lasts more than 7 days, comes back, or occurs with fever, rash, or persistent headache. These could be signs of a serious condition. 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."]}