{"active_ingredient":["Active ingredient (in each 5 mL) Dextromethorphan polistirex equivalent to 30 mg dextromethorphan hydrobromide"],"ask_doctor":["Ask a doctor before use if you have • chronic cough that lasts as occurs with smoking, asthma, or emphysema • cough that occurs with too much phlegm (mucus)"],"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. Allergy Alert: Contains sodium metabisulfite, a sulfite that may cause allergic-type reactions."],"dosage_and_administration":["Directions • shake bottle well before use • measure only with dosing cup provided • do not use dosing cup with other products • dose as follows or as directed by doctor • mL = milliliter adults and children 12 years of age and over 10 mL every 12 hours, not to exceed 20 mL in 24 hours children 6 to under 12 years of age 5 mL every 12 hours, not to exceed 10 mL in 24 hours children 4 to under 6 years of age 2.5 mL every 12 hours, not to exceed 5 mL in 24 hours children under 4 years of age do not use"],"dosage_and_administration_table":["<table width=\"472.95pt\"><col width=\"40%\"/><col width=\"59%\"/><tbody><tr><td styleCode=\"Rrule Botrule Toprule \" valign=\"top\"><paragraph>adults and children 12 years of age and over</paragraph></td><td styleCode=\"Botrule Lrule Toprule \" valign=\"top\"><paragraph>10 mL every 12 hours, not to exceed 20 mL in 24 hours</paragraph></td></tr><tr><td styleCode=\"Rrule Botrule \" valign=\"top\"><paragraph>children 6 to under 12 years of age</paragraph></td><td styleCode=\"Lrule Toprule Botrule \" valign=\"top\"><paragraph>5 mL every 12 hours, not to exceed 10 mL in 24 hours</paragraph></td></tr><tr><td styleCode=\"Rrule Botrule \" valign=\"top\"><paragraph>children 4 to under 6 years of age</paragraph></td><td styleCode=\"Lrule Toprule Botrule \" valign=\"top\"><paragraph>2.5 mL every 12 hours, not to exceed 5 mL in 24 hours</paragraph></td></tr><tr><td styleCode=\"Rrule Botrule Toprule \" valign=\"top\"><paragraph>children under 4 years of age</paragraph></td><td styleCode=\"Botrule Lrule Toprule \" valign=\"top\"><paragraph>do not use</paragraph></td></tr></tbody></table>"],"effective_time":"20260617","id":"05c19eff-0361-4e64-a0a2-b37551452910","inactive_ingredient":["Inactive ingredients D&C Red #30 aluminum lake, D&C Yellow #10 aluminum lake, glycerin, high fructose corn syrup, methylparaben, natural and artificial orange flavor, polysorbate 80, polyvinyl acetate, povidone, propylparaben, purified water, sodium metabisulfite, sodium polystyrene sulfonate, sucrose, tartaric acid, tragacanth gum, triacetin, xanthan gum"],"indications_and_usage":["Uses temporarily relieves • cough due to minor throat and bronchial irritation as may occur with the common cold or inhaled irritants • the impulse to cough to help you 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 (1-800-222-1222)."],"openfda":{"application_number":["ANDA091135"],"brand_name":["CHILDRENS 12 HR COUGH RELIEF"],"generic_name":["DEXTROMETHORPHAN POLISTIREX"],"is_original_packager":[true],"manufacturer_name":["CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED"],"package_ndc":["51316-429-28","51316-429-21"],"product_ndc":["51316-429"],"product_type":["HUMAN OTC DRUG"],"route":["ORAL"],"rxcui":["1373045"],"spl_id":["05c19eff-0361-4e64-a0a2-b37551452910"],"spl_set_id":["380d7f6d-cdfe-4a22-a6e0-13fe2ae12e6c"],"substance_name":["DEXTROMETHORPHAN HYDROBROMIDE"],"unii":["9D2RTI9KYH"]},"package_label_principal_display_panel":["Package/Label Principal Display Panel CVS ™ Ages 4+ years Orange-Flavored Liquid Children’s 12 HR COUGH RELIEF Dextromethorphan Polistirex Extended-Release Oral Suspension Cough Suppressant Compare to Children’s Delsym ® active ingredient No Added Alcohol | For Children & Adults | DAY OR NIGHT 5 FL OZ (148 mL) dosing cup included Contains sodium metabisulfite, a sulfite that may cause allergic-type reactions. cvs-childrens-12hr-cough-relief-orange-carton-image.jpg"],"pregnancy_or_breast_feeding":["If pregnant or breast-feeding, ask a health professional before use."],"purpose":["Purpose Cough suppressant"],"questions":["Questions or comments? 1-800-719-9260"],"set_id":"380d7f6d-cdfe-4a22-a6e0-13fe2ae12e6c","spl_product_data_elements":["CHILDRENS 12 HR COUGH RELIEF dextromethorphan polistirex DEXTROMETHORPHAN HYDROBROMIDE DEXTROMETHORPHAN D&C RED NO. 30 ALUMINUM LAKE D&C YELLOW NO. 10 ALUMINUM LAKE GLYCERIN HIGH FRUCTOSE CORN SYRUP METHYLPARABEN POLYSORBATE 80 POLYVINYL ACETATE POVIDONE, UNSPECIFIED PROPYLPARABEN WATER SODIUM METABISULFITE SODIUM POLYSTYRENE SULFONATE SUCROSE TARTARIC ACID TRAGACANTH TRIACETIN XANTHAN GUM"],"stop_use":["Stop use and ask a doctor if • side effects occur. You may report side effects to FDA at 1-800-FDA-1088. • cough lasts more than 7 days, cough comes back, or occurs with fever, rash or headache that lasts. These could be signs of a serious condition."],"storage_and_handling":["Other information • each 5 mL contains: sodium 5 mg • store at 20° to 25°C (68° to 77°F) • dosing cup provided"],"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. Allergy Alert: Contains sodium metabisulfite, a sulfite that may cause allergic-type reactions. Ask a doctor before use if you have • chronic cough that lasts as occurs with smoking, asthma, or emphysema • cough that occurs with too much phlegm (mucus) Stop use and ask a doctor if • side effects occur. You may report side effects to FDA at 1-800-FDA-1088. • cough lasts more than 7 days, cough comes back, or occurs with fever, rash or headache that lasts. These could be signs of a serious condition. 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 (1-800-222-1222)."]}