{ "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": "2026-06-03", "results": { "skip": 0, "limit": 1, "total": 48 } }, "results": [ { "spl_product_data_elements": [ "Sanatos Multi Symptom Daytime Acetaminophen, Dextromethorphan HBr, Phenylephrine HCI DEXTROMETHORPHAN HYDROBROMIDE DEXTROMETHORPHAN ANHYDROUS CITRIC ACID WATER PHENYLEPHRINE HYDROCHLORIDE PHENYLEPHRINE FD&C YELLOW NO. 6 FOOD YELLOW 3 FREE ACID GLYCERIN SUCROSE ACETAMINOPHEN ACETAMINOPHEN PROPYLENE GLYCOL SODIUM BENZOATE SACCHARIN SODIUM SACCHARIN" ], "spl_unclassified_section": [ "Drug Facts", "Distributed by: Pharmadel LLC Seaford, DE 19973 www.sanatos.com" ], "active_ingredient": [ "Active Ingredients & Purposes Active ingredients (in each 15 mL, 1 tablespoon) Purposes Acetaminophen 325 mg Pain reliever/fever reducer Dextromethorphan HBr 10 mg Cough suppressant Phenylephrine HCI 5 mg Nasal decongestant" ], "active_ingredient_table": [ "
Active ingredients (in each 15 mL, 1 tablespoon)Purposes
Acetaminophen 325 mg Pain reliever/fever reducer
Dextromethorphan HBr 10 mgCough suppressant
Phenylephrine HCI 5 mgNasal decongestant
" ], "purpose": [ "Active ingredients (in each 15 mL, 1 tablespoon) Purposes Acetaminophen 325 mg Pain reliever/fever reducer Dextromethorphan HBr 10 mg Cough suppressant Phenylephrine HCI 5 mg Nasal decongestant" ], "purpose_table": [ "
Active ingredients (in each 15 mL, 1 tablespoon)Purposes
Acetaminophen 325 mg Pain reliever/fever reducer
Dextromethorphan HBr 10 mgCough suppressant
Phenylephrine HCI 5 mgNasal decongestant
" ], "indications_and_usage": [ "Uses temporarily relieves common cold/flu symptoms: minor aches & pains headache sore throat fever nasal congestion cough due to minor throat and bronchial irritation" ], "warnings": [ "Warnings Liver warning: This product contains acetaminophen. Severe liver damage may occur if adults take more than 4,000 mg if acetaminophen in 24 hours child take more than 5 doses in 24 hours taken with other drugs containing acetaminophen adult has 3 or more alcoholic drinks every day while using this product Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include: Skin reddening Blisters Rash If a skin reaction occurs, stop use and seek medical help right away. 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 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. with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist. Ask a doctor before use if you have liver disease heart disease thyroid disease diabetes high blood pressure trouble urinating due to enlarged prostate gland persistent or chronic cough such as occurs with smoking, asthma, or emphysema cough that occurs with too much phlegm (mucus) When using this product do not use more than directed (see overdose warning) avoid alcoholic drinks Stop use and ask a doctor if you get nervos, dizzy or sleepless new symptoms occur fever gets worse or lasts more than 3 days pain or cough gets worse or lasts more than 5 days (children) or 7 days (adults) redness or swelling is present cough comes back or occurs with 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 this and all drugs out of reach of children. Overdose warning: 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." ], "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. with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist." ], "ask_doctor": [ "Ask a doctor before use if you have liver disease heart disease thyroid disease diabetes high blood pressure trouble urinating due to enlarged prostate gland persistent or chronic cough such as occurs with smoking, asthma, or emphysema cough that occurs with too much phlegm (mucus)" ], "when_using": [ "When using this product do not use more than directed (see overdose warning) avoid alcoholic drinks" ], "stop_use": [ "Stop use and ask a doctor if you get nervos, dizzy or sleepless new symptoms occur fever gets worse or lasts more than 3 days pain or cough gets worse or lasts more than 5 days (children) or 7 days (adults) redness or swelling is present cough comes back or occurs with 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 this and all drugs out of reach of children." ], "overdosage": [ "Overdose warning: 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." ], "dosage_and_administration": [ "Directions take only as recommended (see overdose warning) use a dosage cup or tablespoon (TBSP) do not exceed 4 doses per 24 hrs age dose adults & children 12 years & over 30 mL (2 TBSP) every 4 hours children 6 years to under 12 years 15 mL (1 b TBSP) every 4 hours children 4 years to under 6 years ask a doctor children under 4 years do not use when using daytime and nighttime products, carefully read each label to ensure correct dosing." ], "dosage_and_administration_table": [ "
agedose
adults & children 12 years & over30 mL (2 TBSP) every 4 hours
children 6 years to under 12 years15 mL (1 b TBSP) every 4 hours
children 4 years to under 6 yearsask a doctor
children under 4 yearsdo not use
" ], "other_safety_information": [ "Other information sodium content per tablespoon: 10 mg store at room temperature TAMPER EVIDENT: Do not use if imprinted band is missing or broken." ], "inactive_ingredient": [ "Inactive ingredients citric acid, FD&C yellow #6, flavor, glycerin, propylene glycol, purfied water, saccarhin sodium, sodium benzoate, sucrose" ], "questions": [ "Questions? call 1-866-359-3478" ], "package_label_principal_display_panel": [ "Principal Display Panel PDPAPTASantaos Day" ], "set_id": "0ab11691-5b29-55fc-e063-6394a90aa328", "id": "0ab11691-5b2a-55fc-e063-6394a90aa328", "effective_time": "20231117", "version": "1", "openfda": { "application_number": [ "M013" ], "brand_name": [ "Sanatos Multi Symptom Daytime" ], "generic_name": [ "ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCI" ], "manufacturer_name": [ "Pharmadel LLC" ], "product_ndc": [ "55758-055" ], "product_type": [ "HUMAN OTC DRUG" ], "route": [ "ORAL" ], "substance_name": [ "ACETAMINOPHEN", "DEXTROMETHORPHAN HYDROBROMIDE", "PHENYLEPHRINE HYDROCHLORIDE" ], "rxcui": [ "1113705" ], "spl_id": [ "0ab11691-5b2a-55fc-e063-6394a90aa328" ], "spl_set_id": [ "0ab11691-5b29-55fc-e063-6394a90aa328" ], "package_ndc": [ "55758-055-06", "55758-055-25" ], "is_original_packager": [ true ], "unii": [ "362O9ITL9D", "9D2RTI9KYH", "04JA59TNSJ" ] } } ] }