{"active_ingredient":["Active Ingredients and Purposes . Active ingredients (in each softgel) Purposes Acetaminophen 325 mg .............. Pain reliever/ fever reducer Dextromethorphan HBr 15 mg ...... Cough suppressant Doxylamine succinate 6.25 mg ..... Antihistamine"],"active_ingredient_table":["
Active ingredients (in each softgel)Purposes
Acetaminophen 325 mg.............. Pain reliever/ fever reducer
Dextromethorphan HBr 15 mg ......Cough suppressant
Doxylamine succinate 6.25 mg .....Antihistamine
"],"ask_doctor":["Ask a doctor before use if you have liver disease glaucoma a cough that is accompanied by excessive phlegm (mucus) a persistent or chronic cough as occurs with smoking, asthma or emphysema a breathing problem such as emphysema or chronic bronchitis difficulty urinating due to enlargement of the prostate gland"],"ask_doctor_or_pharmacist":["Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers 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 Age Dose adults and children 12 years and older 2 softgels every 6 hours, do not exceed 8 softgels 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 6 hours, do not exceed 8 softgels in a 24 hour period
children 4 to under 12 yearsconsult a doctor
children under 4 yearsdo not use
"],"effective_time":"20260504","id":"5103b658-0839-1ad3-e063-6294a90a7418","inactive_ingredient":["Inactive ingredients D&C yellow #10, FD&C blue #1, gelatin, glycerin, polyethylene glycol 400, povidone k-30, 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 runny nose sneezing itching of the nose or throat itchy, watery eyes due to hay fever 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 Nighttime"],"generic_name":["ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE"],"is_original_packager":[true],"manufacturer_name":["Pharmadel LLC"],"package_ndc":["55758-510-08"],"product_ndc":["55758-510"],"product_type":["HUMAN OTC DRUG"],"route":["ORAL"],"rxcui":["1094549"],"spl_id":["5103b658-0839-1ad3-e063-6294a90a7418"],"spl_set_id":["3dd3ed85-0c0a-8390-e063-6294a90a668e"],"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 excessive heat do not use if blister pack is punctured or torn"],"package_label_principal_display_panel":["Principal Display Panel PDP Sanatos Night"],"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 15 mg ...... Cough suppressant Doxylamine succinate 6.25 mg ..... Antihistamine"],"purpose_table":["
Active ingredients (in each softgel)Purposes
Acetaminophen 325 mg.............. Pain reliever/ fever reducer
Dextromethorphan HBr 15 mg ......Cough suppressant
Doxylamine succinate 6.25 mg .....Antihistamine
"],"questions":["Questions or comments? +1-866-359-3478 (M-F) 9 AM - 5 PM EST or www.pharmadel.com"],"set_id":"3dd3ed85-0c0a-8390-e063-6294a90a668e","spl_product_data_elements":["Sanatos Nighttime Acetaminophen, Dextromethorphan HBr, Doxylamine Succinate SORBITAN FD&C BLUE NO. 1 D&C YELLOW NO. 10 GELATIN GLYCERIN POLYETHYLENE GLYCOL 400 POVIDONE K30 PROPYLENE GLYCOL WATER SORBITOL ACETAMINOPHEN ACETAMINOPHEN DEXTROMETHORPHAN HYDROBROMIDE DEXTROMETHORPHAN DOXYLAMINE SUCCINATE DOXYLAMINE CF02"],"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 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 a rash or a persistent headache that lasts. These could be signs of a serious condition."],"version":"3","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 for this product 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 glaucoma a cough that is accompanied by excessive phlegm (mucus) a persistent or chronic cough as occurs with smoking, asthma or emphysema a breathing problem such as emphysema or chronic bronchitis difficulty urinating due to enlargement of the prostate gland Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers taking the blood thinning drug warfarin When using this product may cause marked drowsiness excitability may occur, especially in children alcohol, sedatives and tranquilizers may increase drowsiness effect avoid alcoholic drinks when taking this product 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 new symptoms occur cough comes back or occurs with a rash or a persistent 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 may cause marked drowsiness excitability may occur, especially in children alcohol, sedatives and tranquilizers may increase drowsiness effect avoid alcoholic drinks when taking this product use caution when driving a motor vehicle or operating machinery"]}