{ "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": "2026-09-02", "results": { "skip": 0, "limit": 100, "total": 2 } }, "results": [ { "effective_time": "20150416", "purpose": [ "Active ingredients (in each 15 mL) Purpose Acetaminophen 500 mg Pain reliever/Fever reducer Dextromethorphan HBr 15 mg Cough suppressant Doxylamine Succinate 6.25 mg Antihistamine" ], "keep_out_of_reach_of_children": [ "Keep out of reach of children." ], "when_using": [ "When using this product do not use more than directed excitability may occur, especially in children marked drowsiness may occur alcohol, sedatives and tranquilizers may increase drowsiness avoid alcoholic drinks be careful when driving a motor vehicle or operating machinery" ], "questions": [ "Questions? 1-888-963-3382. You may also report side effects to this phone number." ], "pregnancy_or_breast_feeding": [ "If pregnant or breast feeding, ask a health professional before use." ], "storage_and_handling": [ "Other information each 15 mL contains: sodium 23 mg tamper evident: do not use if seal under bottle cap printed \"SEALED for YOUR PROTECTION\" is torn or missing dosing cup provided store between 15-30°C (59-86°F) Keep carton for full directions for use" ], "indications_and_usage": [ "Uses temporarily relieves these common cold and flu symptoms: cough due to minor throat and bronchial irritation runny nose and sneezing minor aches and pains sore throat headache fever the impulse to cough to help you get to sleep" ], "set_id": "11f9df40-5009-4185-a139-9c34f52611ed", "id": "00ca7981-9fde-4dbc-9822-19c7f83a057f", "ask_doctor_or_pharmacist": [ "Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin. you are taking sedatives or tranquilizers." ], "active_ingredient": [ "Active ingredients (in each 15 mL) Purpose Acetaminophen 500 mg Pain reliever/Fever reducer Dextromethorphan HBr 15 mg Cough suppressant Doxylamine Succinate 6.25 mg Antihistamine" ], "inactive_ingredient": [ "Inactive ingredients anhydrous citric acid, anhydrous trisodium citrate, FD&C Blue #1, FD&C Red #40, flavors, glycerin, polyethylene glycol, propylene glycol, purified water, saccharin sodium, sodium benzoate, sugar" ], "warnings": [ "Warnings Liver warning This product contains acetaminophen. Severe liver damage may occur if you take: more than 4 doses in 24 hours, which is the maximum daily amount with other drugs containing acetaminophen 3 or more alcoholic drinks daily while using this product Sore throat warning If sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea or vomiting, consult a doctor promptly. Do not use with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist. 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 liver disease glaucoma trouble urinating due to an enlarged prostate gland a breathing problem such as emphysema or chronic bronchitis persistent or chronic cough such as occurs with smoking, asthma or emphysema cough that occurs with too much phlegm (mucus) a sodium restricted diet Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin. you are taking sedatives or tranquilizers. When using this product do not use more than directed excitability may occur, especially in children marked drowsiness may occur alcohol, sedatives and tranquilizers may increase drowsiness avoid alcoholic drinks be careful when driving a motor vehicle or operating machinery Stop use and ask a doctor if pain or cough gets worse or lasts more than 7 days fever gets worse or lasts more than 3 days redness or swelling is present new symptoms occur cough comes back or occurs with 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. Overdose warning Taking more than the recommended dose (overdose) may cause liver damage. In case of overdose, get medical help or contact a Poison Control Center right away. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms." ], "spl_product_data_elements": [ "Delsym Night Time Cough and Cold Acetaminophen, Dextromethorphan Hydrobromide, and Doxylamine Succinate Acetaminophen Acetaminophen Dextromethorphan Hydrobromide Dextromethorphan Doxylamine Succinate Doxylamine anhydrous citric acid anhydrous trisodium citrate FD&C Blue No. 1 FD&C Red No. 40 glycerin polyethylene glycols propylene glycol water saccharin sodium sodium benzoate sucrose" ], "ask_doctor": [ "Ask a doctor before use if you have liver disease glaucoma trouble urinating due to an enlarged prostate gland a breathing problem such as emphysema or chronic bronchitis persistent or chronic cough such as occurs with smoking, asthma or emphysema cough that occurs with too much phlegm (mucus) a sodium restricted diet" ], "openfda": {}, "version": "3", "dosage_and_administration": [ "Directions do not take more than directed (see Overdose warning ) do not take more than 4 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 mL = milliliter Adults and Children 12 years and older: 30 mL in dosing cup provided every 6 hours. Children under 12 years of age: Do not use." ], "spl_unclassified_section": [ "Drug Facts", "Dist. by: Reckitt Benckiser Inc. Parsippany, NJ 07054-0224" ], "stop_use": [ "Stop use and ask a doctor if pain or cough gets worse or lasts more than 7 days fever gets worse or lasts more than 3 days redness or swelling is present new symptoms occur cough comes back or occurs with rash or persistent headache. These could be signs of a serious condition." ], "do_not_use": [ "Do not use with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist. 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." ], "active_ingredient_table": [ "
Active ingredients (in each 15 mL) Purpose
Acetaminophen 500 mg Pain reliever/Fever reducer
Dextromethorphan HBr 15 mg Cough suppressant
Doxylamine Succinate 6.25 mg Antihistamine
" ], "package_label_principal_display_panel": [ "PRINCIPAL DISPLAY PANEL - 120 mL Carton SEE NEW WARNINGS & INGREDIENTS Delsym ® NIGHT TIME COUGH & COLD Acetaminophen (Pain Reliever / Fever Reducer) Dextromethorphan HBr (Cough Suppressant) Doxylamine succinate (Antihistamine) Cough Runny Nose & Sneezing Sore Throat Body Aches Liquid 120 mL (4 fl oz) for Ages 12+ Principal Display Panel - 120 mL Carton" ], "purpose_table": [ "
Active ingredients (in each 15 mL) Purpose
Acetaminophen 500 mg Pain reliever/Fever reducer
Dextromethorphan HBr 15 mg Cough suppressant
Doxylamine Succinate 6.25 mg Antihistamine
" ] }, { "effective_time": "20150416", "purpose": [ "Active ingredients (in each 5 mL) Purpose Diphenhydramine HCl 12.5 mg Antihistamine/Cough suppressant Phenylephrine HCl 5 mg Nasal decongestant" ], "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." ], "when_using": [ "When using this product do not use more than directed excitability may occur, especially in children marked drowsiness may occur alcohol, sedatives and tranquilizers may increase drowsiness avoid alcoholic drinks be careful when driving a motor vehicle or operating machinery" ], "questions": [ "Questions? 1-888-963-3382 You may also report side effects to this phone number." ], "pregnancy_or_breast_feeding": [ "If pregnant or breast feeding, ask a health professional before use." ], "storage_and_handling": [ "Other information each 5 mL contains: sodium 10 mg tamper evident: do not use if neckband on bottle cap is broken or missing dosing cup provided store between 15-30°C (59-86°F) Keep carton for full directions for use" ], "indications_and_usage": [ "Uses temporarily controls cough due to minor throat and bronchial irritation and relieves nasal congestion as may occur with a cold temporarily relieves the following symptoms due to hay fever or other upper respiratory allergies: sneezing runny nose itchy, watery eyes itchy nose or throat" ], "set_id": "eb4f3a43-52a3-4f6f-8280-fe1ce730de7e", "id": "8f300bcd-9bd7-4a33-a44b-8f84180eb4ae", "ask_doctor_or_pharmacist": [ "Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers." ], "active_ingredient": [ "Active ingredients (in each 5 mL) Purpose Diphenhydramine HCl 12.5 mg Antihistamine/Cough suppressant Phenylephrine HCl 5 mg Nasal decongestant" ], "dosage_and_administration_table": [ "
Age (year) Dose (mL)
adults and children 12 years of age and over 10 mL every 4 hours
children 6 to under 12 years of age 5 mL every 4 hours
children 4 to under 6 years of age do not use unless directed by a doctor
children under 4 years of age do not use
" ], "inactive_ingredient": [ "Inactive ingredients anhydrous citric acid, anhydrous trisodium citrate, carboxymethylcellulose sodium, edetate disodium, FD&C Blue #1, FD&C Red #40, flavors, glycerin, propyl gallate, propylene glycol, purified water, sodium benzoate, sorbitol, sucralose" ], "warnings": [ "Warnings Do not use to make a child sleepy with any other product containing diphenhydramine, even one used on the skin 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 heart disease diabetes high blood pressure thyroid disease glaucoma trouble urinating due to an enlarged prostate gland a breathing problem such as emphysema or chronic bronchitis persistent or chronic cough such as occurs with smoking, asthma or emphysema cough that occurs with too much phlegm (mucus) Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers. When using this product do not use more than directed excitability may occur, especially in children marked drowsiness may occur alcohol, sedatives and tranquilizers may increase drowsiness avoid alcoholic drinks be careful when driving a motor vehicle or operating machinery Stop use and ask a doctor if nervousness, dizziness or sleeplessness occur symptoms do not get better within 7 days or occur with fever cough lasts more than 7 days, comes back, or occurs with 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." ], "spl_product_data_elements": [ "Delsym Childrens Night Time Cough and Cold Diphenhydramine Hydrochloride and Phenylephrine Hydrochloride Diphenhydramine Hydrochloride Diphenhydramine Phenylephrine Hydrochloride Phenylephrine anhydrous citric acid anhydrous trisodium citrate carboxymethylcellulose sodium edetate disodium FD&C Blue No. 1 FD&C Red No. 40 glycerin propyl gallate propylene glycol water sodium benzoate sorbitol sucralose" ], "ask_doctor": [ "Ask a doctor before use if you have heart disease diabetes high blood pressure thyroid disease glaucoma trouble urinating due to an enlarged prostate gland a breathing problem such as emphysema or chronic bronchitis persistent or chronic cough such as occurs with smoking, asthma or emphysema cough that occurs with too much phlegm (mucus)" ], "openfda": {}, "version": "5", "dosage_and_administration": [ "Directions do not take more than directed 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 mL = milliliter Age (year) Dose (mL) adults and children 12 years of age and over 10 mL every 4 hours children 6 to under 12 years of age 5 mL every 4 hours children 4 to under 6 years of age do not use unless directed by a doctor children under 4 years of age do not use" ], "spl_unclassified_section": [ "Drug Facts", "Dist. by: Reckitt Benckiser Inc. Parsippany, NJ 07054-0224" ], "stop_use": [ "Stop use and ask a doctor if nervousness, dizziness or sleeplessness occur symptoms do not get better within 7 days or occur with fever cough lasts more than 7 days, comes back, or occurs with fever, rash or persistent headache. These could be signs of a serious condition." ], "do_not_use": [ "Do not use to make a child sleepy with any other product containing diphenhydramine, even one used on the skin 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." ], "active_ingredient_table": [ "
Active ingredients (in each 5 mL) Purpose
Diphenhydramine HCl 12.5 mg Antihistamine/Cough suppressant
Phenylephrine HCl 5 mg Nasal decongestant
" ], "package_label_principal_display_panel": [ "PRINCIPAL DISPLAY PANEL - 118 mL Carton SEE NEW INGREDIENTS Delsym ® Children's NIGHT TIME COUGH & COLD Diphenhydramine HCl (Cough Suppressant/Antihistamine) Phenylephrine HCl (Nasal Decongestant) ✓ Cough ✓ Runny Nose ✓ Stuffy Nose ✓ Sneezing Grape Flavored Liquid 118 mL (4 fl oz) Principal Display Panel - 118 mL Carton" ], "purpose_table": [ "
Active ingredients (in each 5 mL) Purpose
Diphenhydramine HCl 12.5 mg Antihistamine/Cough suppressant
Phenylephrine HCl 5 mg Nasal decongestant
" ] } ] }