{"active_ingredient":["Active ingredients and Purposes . Purposes Active ingredients(in each softgel) Purpose Acetaminophen 325mg ...........................................................Pain reliever/ fever reducer Dextromethorphan HBr 20mg....................................................Cough suppressant Doxylamine succinate 12.5mg.................................................... Antihistamine"],"ask_doctor":["Ask a doctor before use if you have liver disease glaucoma a persistent or chronic cough such as occurs with smoking, asthma, or emphysema a cough that is accompanied by excessive phlegm (mucus) a breathing problem such as emphysema or chronic bronchitis difficulty in urination 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 taking sedatives or tranquilizers"],"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 if you are taking other cold/flu products, read complete labeling before dosing Age Dose adults and children 12 years and older two (2) softgels every 6 hours, do not exceed 8 softgels in 24 hours children 4 to under 12 years ask a doctor children under 4 years do not use"],"dosage_and_administration_table":["<table border=\"0\" width=\"100%\"><tbody><tr><td>Age</td><td>Dose</td></tr><tr><td>adults and children 12 years and older</td><td> two (2) softgels every 6 hours, do not exceed 8 softgels in 24 hours</td></tr><tr><td>children 4 to under 12 years </td><td>ask a doctor</td></tr><tr><td>children under 4 years</td><td>do not use</td></tr></tbody></table>"],"effective_time":"20260401","id":"4c26c8bf-0144-ddca-e063-6294a90a3552","inactive_ingredient":["Inactive ingredients D&C yellow #10, FD&C blue #1, gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, purified water, sorbitol sorbitan solution, titanium dioxide"],"indications_and_usage":["Uses Temporarily relieves the common cold/flu symptoms associated with minor aches and pains headache sore throat runny nose cough due to minor throat and bronchial irritation sneezing temporarily reduces fever"],"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. 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 Nighttime Relief"],"generic_name":["ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE"],"is_original_packager":[true],"manufacturer_name":["Pharmadel LLC"],"package_ndc":["55758-515-08"],"product_ndc":["55758-515"],"product_type":["HUMAN OTC DRUG"],"route":["ORAL"],"rxcui":["2739790"],"spl_id":["4c26c8bf-0144-ddca-e063-6294a90a3552"],"spl_set_id":["4c26c8bf-0143-ddca-e063-6294a90a3552"],"substance_name":["ACETAMINOPHEN","DEXTROMETHORPHAN HYDROBROMIDE","DOXYLAMINE SUCCINATE"],"unii":["362O9ITL9D","9D2RTI9KYH","V9BI9B5YI2"]},"other_safety_information":["Other information store between 68-77°F (20-25°C) avoid excess heat"],"package_label_principal_display_panel":["Principal Display Panel PDP SANATOS NIGHTTIME SG"],"pregnancy_or_breast_feeding":["If pregnant or breast-feeding, ask a health professional before use."],"purpose":["Purposes Active ingredients(in each softgel) Purpose Acetaminophen 325mg ...........................................................Pain reliever/ fever reducer Dextromethorphan HBr 20mg....................................................Cough suppressant Doxylamine succinate 12.5mg.................................................... Antihistamine"],"questions":["Questions? +1-866-359-3478 (M-F) 9AM – 5PM EST or www.pharmadel.com"],"set_id":"4c26c8bf-0143-ddca-e063-6294a90a3552","spl_product_data_elements":["Sanatos Nighttime Relief Acetaminophen, Dextromethorphan HBr, Doxylamine succinate D&C YELLOW NO. 10 FD&C BLUE NO. 1 GELATIN, UNSPECIFIED GLYCERIN POLYETHYLENE GLYCOL, UNSPECIFIED POVIDONE, UNSPECIFIED PROPYLENE GLYCOL WATER SORBITOL SOLUTION SORBITAN ACETAMINOPHEN ACETAMINOPHEN DEXTROMETHORPHAN HYDROBROMIDE DEXTROMETHORPHAN DOXYLAMINE SUCCINATE DOXYLAMINE TITANIUM DIOXIDE clear 603"],"spl_unclassified_section":["Drug Facts .","Dist. by/ por: Pharmadel LLC New Castle, DE 19947 +1-866-359-3478 †This product is not manufactured or distributed by Procter & Gamble, owner of the registered trademark Vicks® Nyquil® Liquicap"],"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 any new symptoms occur cough comes back or occurs with rash or headache that lasts. These could be signs of a serious condition."],"version":"1","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 amount with other drugs containing acetaminophen 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 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 a persistent or chronic cough such as occurs with smoking, asthma, or emphysema a cough that is accompanied by excessive phlegm (mucus) a breathing problem such as emphysema or chronic bronchitis difficulty in urination due to enlargement of the prostate gland Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin taking sedatives or tranquilizers When using this product excitability may occur, especially in children marked drowsiness may occur alcoholic, sedatives, and tranquillizers may increase drowsiness avoid alcoholic beverages use caution 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 any 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 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 excitability may occur, especially in children marked drowsiness may occur alcoholic, sedatives, and tranquillizers may increase drowsiness avoid alcoholic beverages use caution when driving a motor vehicle or operating machinery"]}