{ "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": [ "DRx Choice Long Acting Cough Dextromethorphan HBr DEXTROMETHORPHAN HYDROBROMIDE DEXTROMETHORPHAN ANHYDROUS CITRIC ACID EDETATE DISODIUM FD&C RED NO. 40 POTASSIUM CITRATE PROPYLENE GLYCOL WATER SODIUM BENZOATE SORBITOL SUCRALOSE XANTHAN GUM" ], "active_ingredient": [ "Active ingredient (in each 10 mL) Dextromethorphan HBr, USP 30 mg" ], "purpose": [ "Purpose Cough suppressant" ], "indications_and_usage": [ "Uses temporarily relieves cough due to minor throat and bronchial irritation as may occur with a cold" ], "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, 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. 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 at 1-800-222-1222." ], "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 ▪ cough that occurs with too much phlegm (mucus) ▪ cough that lasts or is chronic such as occurs with smoking, asthma, or emphysema" ], "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." ], "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 at 1-800-222-1222." ], "dosage_and_administration": [ "Directions ▪ do not take more than 4 doses in a 24-hour period ▪ measure only with dosing cup provided ▪ keep dosing cup with product ▪ mL = milliliter ▪ this adult product is not intended for use in children under 12 years of age age dose adults and children 12 years and over 10 mL every 6 to 8 hours children under 12 years do not use" ], "dosage_and_administration_table": [ "
agedose
adults and children 12 years and over10 mL every 6 to 8 hours
children under 12 years do not use
" ], "spl_unclassified_section": [ "Other information ▪ each 10 ml contains : sodium 3 mg ▪ store at room temperature" ], "inactive_ingredient": [ "Inactive ingredients anhydrous citric acid, disodium edetate, FD&C red 40, flavor, potassium citrate, propylene glycol, purified water, sodium benzoate, sorbitol solution, sucralose, xanthan gum" ], "questions": [ "Questions or comments? 1-866-467-2748" ], "package_label_principal_display_panel": [ "Principal Display Panel *Compare to the active ingredient in Adult Robitussin ® Long-Acting Cough * NDC 68163-742-04 DRx Choice long-acting cough Dextromethorphan HBr (Cough Suppressant) Relieves: Cough 8 HOURS RELIEF No Added Alcohol Sugar-Free For Ages 12 & Over 4 FL OZ (118mL) *This product is not manufactured or distributed by Pfizer, owner of the registered trademark Adult Robitussin® Long-Acting Cough. TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL ON THE BOTTLE IS BROKEN OR MISSING. IMPORTANT: Keep this carton for future reference for full labelling. Manufactured by: Raritan Pharmaceuticals 8 Joanna Court, East Brunswick, NJ 08816 DRx Choice Long-Acting Cough 4 FL OZ" ], "set_id": "875b40bd-7955-4048-abbf-7f43d9ea3ac5", "id": "817658b8-a331-4903-9a11-5c8715affe8e", "effective_time": "20260909", "version": "4", "openfda": { "application_number": [ "M012" ], "brand_name": [ "DRx Choice Long Acting Cough" ], "generic_name": [ "DEXTROMETHORPHAN HBR" ], "manufacturer_name": [ "RARITAN PHARMACEUTICALS" ], "product_ndc": [ "68163-742" ], "product_type": [ "HUMAN OTC DRUG" ], "route": [ "ORAL" ], "substance_name": [ "DEXTROMETHORPHAN HYDROBROMIDE" ], "rxcui": [ "1090496" ], "spl_id": [ "817658b8-a331-4903-9a11-5c8715affe8e" ], "spl_set_id": [ "875b40bd-7955-4048-abbf-7f43d9ea3ac5" ], "package_ndc": [ "68163-742-04" ], "is_original_packager": [ true ], "unii": [ "9D2RTI9KYH" ] } } ] }