{ "meta": { "disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.", "terms": "https://open.fda.gov/terms/", "license": "https://open.fda.gov/license/", "last_updated": "2026-10-02", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "spl_product_data_elements": [ "Delsym Dextromethorphan DEXTROMETHORPHAN DEXTROMETHORPHAN DEXTROMETHORPHAN HYDROBROMIDE POLISTIREX CITRIC ACID MONOHYDRATE EDETATE DISODIUM ETHYLCELLULOSE, UNSPECIFIED FD&C YELLOW NO. 6 HIGH FRUCTOSE CORN SYRUP METHYLPARABEN POLYETHYLENE GLYCOL 3350 POLYSORBATE 80 PROPYLENE GLYCOL PROPYLPARABEN WATER SUCROSE TRAGACANTH XANTHAN GUM" ], "spl_unclassified_section": [ "Drug Facts", "Distributed by: RB Health (US) Parsippany, NJ 07054-0224" ], "active_ingredient": [ "Active ingredient (in each 5 mL) Dextromethorphan polistirex equivalent to 30 mg dextromethorphan hydrobromide" ], "purpose": [ "Purpose Cough suppressant" ], "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" ], "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 chronic cough that lasts such as occurs with smoking, asthma, or emphysema cough that occurs with too much phlegm (mucus) Stop use and ask a doctor if cough lasts more than 7 days, 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." ], "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." ], "ask_doctor": [ "Ask a doctor before use if you have chronic cough that lasts such as occurs with smoking, asthma, or emphysema cough that occurs with too much phlegm (mucus)" ], "stop_use": [ "Stop use and ask a doctor if cough lasts more than 7 days, comes back, or occurs with fever, rash, or headache that lasts. These could be signs of a serious condition." ], "pregnancy_or_breast_feeding": [ "If pregnant or breast-feeding, ask a health professional before use." ], "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." ], "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 a doctor 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": [ "
adults and children 12 years of age and over10 mL every 12 hours, not to exceed 20 mL in 24 hours
children 6 to under 12 years of age5 mL every 12 hours, not to exceed 10 mL in 24 hours
children 4 to under 6 years of age2.5 mL every 12 hours, not to exceed 5 mL in 24 hours
children under 4 years of agedo not use
" ], "storage_and_handling": [ "Other information each 5 mL contains: sodium 7 mg store at 20-25°C (68-77°F) dosing cup provided" ], "inactive_ingredient": [ "Inactive ingredients citric acid, edetate disodium, ethylcellulose, FD&C yellow no. 6, flavor, high fructose corn syrup, methylparaben, partially hydrogenated vegetable oil (soybean, cottonseed), polyethylene glycol 3350, polysorbate 80, propylene glycol, propylparaben, purified water, sucrose, tragacanth, xanthan gum" ], "questions": [ "Questions? 1-866-682-4639 You may also report side effects to this phone number." ], "package_label_principal_display_panel": [ "PRINCIPAL DISPLAY PANEL - 148 mL Bottle Carton NDC 63824-175-65 Delsym ® Dextromethorphan Polistirex Extended-Release Suspension (Cough Suppressant) COUGH 12 HOUR COUGH RELIEF Orange Flavored Liquid 148 mL (5 fl oz) Day or Night SULFITE FREE ALCOHOL FREE PRINCIPAL DISPLAY PANEL - 148 mL Bottle Carton" ], "set_id": "e3e1d126-76c2-4776-8ce0-449625b7e6ba", "id": "5b143305-ab62-63e0-e063-6294a90aed7d", "effective_time": "20260909", "version": "15", "openfda": { "application_number": [ "NDA018658" ], "brand_name": [ "Delsym" ], "generic_name": [ "DEXTROMETHORPHAN" ], "manufacturer_name": [ "Reckitt Benckiser LLC" ], "product_ndc": [ "63824-175" ], "product_type": [ "HUMAN OTC DRUG" ], "route": [ "ORAL" ], "substance_name": [ "DEXTROMETHORPHAN" ], "rxcui": [ "1373045", "1373128" ], "spl_id": [ "5b143305-ab62-63e0-e063-6294a90aed7d" ], "spl_set_id": [ "e3e1d126-76c2-4776-8ce0-449625b7e6ba" ], "package_ndc": [ "63824-175-63", "63824-175-65", "63824-175-75", "63824-175-22" ], "is_original_packager": [ true ], "nui": [ "N0000181821", "N0000182149", "N0000181819", "N0000182147" ], "pharm_class_epc": [ "Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC]", "Sigma-1 Agonist [EPC]" ], "pharm_class_moa": [ "Uncompetitive NMDA Receptor Antagonists [MoA]", "Sigma-1 Receptor Agonists [MoA]" ], "unii": [ "7355X3ROTS" ] } } ] }