{ "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": "2026-06-09", "results": { "skip": 0, "limit": 1, "total": 6 } }, "results": [ { "spl_product_data_elements": [ "Sanatos Daytime Acetaminophen, Dextromethorphan, Phenylephrine FD&C RED NO. 40 FD&C YELLOW NO. 6 GELATIN GLYCERIN POLYETHYLENE GLYCOL 400 POVIDONE K30 PROPYLENE GLYCOL WATER SORBITOL ACETAMINOPHEN ACETAMINOPHEN DEXTROMETHORPHAN HYDROBROMIDE DEXTROMETHORPHAN PHENYLEPHRINE HYDROCHLORIDE PHENYLEPHRINE SORBITAN CF01" ], "spl_unclassified_section": [ "Drug Facts .", "Dist by/ por: PHARMADEL LLC New Castle, DE 19720 www.pharmadel.com" ], "active_ingredient": [ "Active ingredients and Purposes . Active ingredients (in each softgel) Purposes Acetaminophen 325 mg .................... Pain reliever/ fever reducer Dextromethorphan HBr 10 mg ......... Cough suppressant Phenylephrine HCl 5 mg .................. Nasal decongestant" ], "active_ingredient_table": [ "
Active ingredients (in each softgel)Purposes
Acetaminophen 325 mg ....................Pain reliever/ fever reducer
Dextromethorphan HBr 10 mg .........Cough suppressant
Phenylephrine HCl 5 mg ..................Nasal decongestant
" ], "purpose": [ "Active ingredients (in each softgel) Purposes Acetaminophen 325 mg .................... Pain reliever/ fever reducer Dextromethorphan HBr 10 mg ......... Cough suppressant Phenylephrine HCl 5 mg .................. Nasal decongestant" ], "purpose_table": [ "
Active ingredients (in each softgel)Purposes
Acetaminophen 325 mg ....................Pain reliever/ fever reducer
Dextromethorphan HBr 10 mg .........Cough suppressant
Phenylephrine HCl 5 mg ..................Nasal decongestant
" ], "indications_and_usage": [ "Uses Temporarily relieves cough-cold symptoms cough due to minor throat and bronchial irritation headache minor aches and pains nasal congestion sinus congestion and pressure stuffy nose temporarily reduces fever" ], "warnings": [ "Warnings Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take more than 8 softgels in 24 hours , which is the maximum daily with other drugs containing acetaminophen 3 or more alcoholic drinks daily 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. 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 heart disease high blood pressure thyroid disease diabetes a cough that is accompanied by excessive phlegm (mucus) a persistent or chronic cough as occurs with smoking, asthma or emphysema difficulty urinating due to enlargement of the prostate gland When using this product do not exceed recommended dosage Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin Stop use and ask a doctor if nervousness, dizziness, or sleeplessness occur pain, cough or nasal congestions 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 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 accidental overdose, get medical help or contact a Poison Control Center right away. Prompt 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 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_doctor": [ "Ask a doctor before use if you have liver disease heart disease high blood pressure thyroid disease diabetes a cough that is accompanied by excessive phlegm (mucus) a persistent or chronic cough as occurs with smoking, asthma or emphysema difficulty urinating due to enlargement of the prostate gland" ], "when_using": [ "When using this product do not exceed recommended dosage" ], "ask_doctor_or_pharmacist": [ "Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin" ], "stop_use": [ "Stop use and ask a doctor if nervousness, dizziness, or sleeplessness occur pain, cough or nasal congestions 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 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 accidental overdose, get medical help or contact a Poison Control Center right away. Prompt 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 do not exceed 4 doses in a 24 hour period Age Dose adults and children 12 years and older 2 softgels every 4 hours, do not exceed 6 doses in a 24 hour period children 4 to under 12 years consult a doctor children under 4 years do not use" ], "dosage_and_administration_table": [ "
AgeDose
adults and children 12 years and older2 softgels every 4 hours, do not exceed 6 doses in a 24 hour period
children 4 to under 12 yearsconsult a doctor
children under 4 yearsdo not use
" ], "other_safety_information": [ "Other information store between 68-77°F (20-25°C) avoid excessive heat do not use if blister pack unit is punctured or torn" ], "inactive_ingredient": [ "Inactive ingredients FD&C red #40, FD&C yellow #6, gelatin, glycerol, polyethylene glycol 400, povidone k30, propylene glycol, sorbitol sorbitan solution, water" ], "questions": [ "Questions or comments? +1-866-359-3478 (M-F) 9 AM - 5 PM EST or www.pharmadel.com" ], "package_label_principal_display_panel": [ "Principal Display Panel Sanatos Day SG PDP" ], "set_id": "3bddcd5a-7776-49ff-e063-6294a90a5dd1", "id": "4d7ad592-5b3c-e731-e063-6394a90a11e0", "effective_time": "20260320", "version": "2", "openfda": { "application_number": [ "M012" ], "brand_name": [ "Sanatos Daytime" ], "generic_name": [ "ACETAMINOPHEN, DEXTROMETHORPHAN, PHENYLEPHRINE" ], "manufacturer_name": [ "Pharmadel LLC" ], "product_ndc": [ "55758-508" ], "product_type": [ "HUMAN OTC DRUG" ], "route": [ "ORAL" ], "substance_name": [ "ACETAMINOPHEN", "DEXTROMETHORPHAN HYDROBROMIDE", "PHENYLEPHRINE HYDROCHLORIDE" ], "rxcui": [ "1086997" ], "spl_id": [ "4d7ad592-5b3c-e731-e063-6394a90a11e0" ], "spl_set_id": [ "3bddcd5a-7776-49ff-e063-6294a90a5dd1" ], "package_ndc": [ "55758-508-08" ], "is_original_packager": [ true ], "unii": [ "362O9ITL9D", "9D2RTI9KYH", "04JA59TNSJ" ] } } ] }