{"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":["<table border=\"0\" width=\"100%\"><tbody><tr><td><content styleCode=\"bold\"><content styleCode=\"italics\">Active ingredients (in each softgel)</content></content></td><td><content styleCode=\"bold\"><content styleCode=\"italics\">Purposes</content></content></td></tr><tr><td><content styleCode=\"bold\">Acetaminophen 325 mg ....................</content></td><td><content styleCode=\"bold\">Pain reliever/ fever reducer</content></td></tr><tr><td>Dextromethorphan HBr 10 mg .........</td><td><paragraph>Cough suppressant</paragraph></td></tr><tr><td>Phenylephrine HCl 5 mg ..................</td><td><paragraph>Nasal decongestant</paragraph></td></tr></tbody></table>"],"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"],"ask_doctor_or_pharmacist":["Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin"],"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."],"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":["<table border=\"0\" width=\"100%\"><tbody><tr><td><content styleCode=\"bold\">Age</content></td><td><paragraph><content styleCode=\"bold\">Dose</content></paragraph></td></tr><tr><td>adults and children 12 years and older</td><td>2 softgels every 4 hours, <content styleCode=\"bold\">do not exceed 6 doses in a 24 hour period</content></td></tr><tr><td>children 4 to under 12 years</td><td>consult a doctor</td></tr><tr><td>children under 4 years</td><td><content styleCode=\"bold\">do not use</content></td></tr></tbody></table>"],"effective_time":"20260320","id":"4d7ad592-5b3c-e731-e063-6394a90a11e0","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"],"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"],"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."],"openfda":{"application_number":["M012"],"brand_name":["Sanatos Daytime"],"generic_name":["ACETAMINOPHEN, DEXTROMETHORPHAN, PHENYLEPHRINE"],"is_original_packager":[true],"manufacturer_name":["Pharmadel LLC"],"package_ndc":["55758-508-08"],"product_ndc":["55758-508"],"product_type":["HUMAN OTC DRUG"],"route":["ORAL"],"rxcui":["1086997"],"spl_id":["4d7ad592-5b3c-e731-e063-6394a90a11e0"],"spl_set_id":["3bddcd5a-7776-49ff-e063-6294a90a5dd1"],"substance_name":["ACETAMINOPHEN","DEXTROMETHORPHAN HYDROBROMIDE","PHENYLEPHRINE HYDROCHLORIDE"],"unii":["362O9ITL9D","9D2RTI9KYH","04JA59TNSJ"]},"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"],"package_label_principal_display_panel":["Principal Display Panel Sanatos Day SG PDP"],"pregnancy_or_breast_feeding":["If pregnant or breast-feeding, ask a health professional before use."],"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":["<table border=\"0\" width=\"100%\"><tbody><tr><td><content styleCode=\"bold\"><content styleCode=\"italics\">Active ingredients (in each softgel)</content></content></td><td><content styleCode=\"bold\"><content styleCode=\"italics\">Purposes</content></content></td></tr><tr><td><content styleCode=\"bold\">Acetaminophen 325 mg ....................</content></td><td><content styleCode=\"bold\">Pain reliever/ fever reducer</content></td></tr><tr><td>Dextromethorphan HBr 10 mg .........</td><td><paragraph>Cough suppressant</paragraph></td></tr><tr><td>Phenylephrine HCl 5 mg ..................</td><td><paragraph>Nasal decongestant</paragraph></td></tr></tbody></table>"],"questions":["Questions or comments? +1-866-359-3478 (M-F) 9 AM - 5 PM EST or www.pharmadel.com"],"set_id":"3bddcd5a-7776-49ff-e063-6294a90a5dd1","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"],"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."],"version":"2","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."],"when_using":["When using this product do not exceed recommended dosage"]}