{"active_ingredient":["Active ingredients (in each Softgel) Acetaminophen 325 mg Dextromethorphan HBr 10 mg Doxylamine succinate 6.25 mg"],"ask_doctor":["Ask a doctor before use if you have liver disease glaucoma cough that occurs with too much phlegm (mucus) a breathing problem or chronic cough that lasts or as occurs with smoking, asthma, chronic bronchitis or emphysema trouble urinating due to enlarged 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. to make a child sleep"],"dosage_and_administration":["Directions take only as directed - see Overdose warning do not exceed 4 doses per 24 hrs adults & children 12 yrs & over 2 softgels with water every 4 hrs children 4 to under 12 yrs ask a doctor children under 4 yrs do not use when using other Nighttime or Daytime products, carefully read each label to ensure correct dosing"],"dosage_and_administration_table":["
adults & children 12 yrs & over 2 softgels with water every 4 hrs
children 4 to under 12 yrs ask a doctor
children under 4 yrs do not use
"],"effective_time":"20250311","id":"300bf27f-7450-7366-e063-6394a90acbcb","inactive_ingredient":["Inactive ingredients D&C yellow #10, FD&C blue #1, gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, purified water, sorbitol special, and white edible ink"],"indications_and_usage":["Uses temporarily relieves common cold/flu symptoms: cough due to minor throat & bronchial irritation sore throat headache minor aches & pains fever runny nose & sneezing"],"keep_out_of_reach_of_children":["Keep out of reach of children."],"openfda":{"application_number":["M012"],"brand_name":["Ultra Concentrated Nighttime COLD AND FLU"],"generic_name":["ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE"],"is_original_packager":[true],"manufacturer_name":["PuraCap Pharmaceutical LLC"],"package_ndc":["51013-668-01"],"product_ndc":["51013-668"],"product_type":["HUMAN OTC DRUG"],"route":["ORAL"],"rxcui":["1426334"],"spl_id":["300bf27f-7450-7366-e063-6394a90acbcb"],"spl_set_id":["300bf27f-744f-7366-e063-6394a90acbcb"],"substance_name":["ACETAMINOPHEN","DEXTROMETHORPHAN HYDROBROMIDE","DOXYLAMINE SUCCINATE"],"unii":["362O9ITL9D","9D2RTI9KYH","V9BI9B5YI2"]},"overdosage":["Overdose warning Taking more than directed can cause serious health problems. In case of overdose, get medical help or contact a Poison Control Center right away. Quick medical attention is critical for adults & for children even if you do not notice any signs or symptoms."],"package_label_principal_display_panel":["PRINCIPAL DISPLAY PANEL Nitetime Cold & Flu 10 SOFTGELS NDC 51013-668-01 * Compare to the active ingredients in VICKS ® NyQuil ® Cold & Flu carton label"],"pregnancy_or_breast_feeding":["If pregnant or breast-feeding, ask a health care professional before use."],"purpose":["Purposes Pain reliever/fever reducer Cough suppressant Antihistamine"],"questions":["Questions or comments? Call toll free: 1-855-215-8180"],"set_id":"300bf27f-744f-7366-e063-6394a90acbcb","spl_product_data_elements":["Ultra Concentrated Nighttime COLD AND FLU acetaminophen, dextromethorphan hydrobromide, doxylamine succinate D&C YELLOW NO. 10 FD&C BLUE NO. 1 GELATIN GLYCERIN POLYETHYLENE GLYCOL, UNSPECIFIED POVIDONE PROPYLENE GLYCOL WATER SORBITOL ACETAMINOPHEN ACETAMINOPHEN DEXTROMETHORPHAN HYDROBROMIDE DEXTROMETHORPHAN DOXYLAMINE SUCCINATE DOXYLAMINE clear oval P10"],"spl_unclassified_section":["Drug Facts"],"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 rash or headache that lasts. These could be signs of a serious condition."],"storage_and_handling":["Other information store at room temperature 15°-30°C (59°-86°F)"],"version":"1","warnings":["Warnings Liver warning This product contains acetaminophen. Severe liver damage may occur if you take more than 4 doses in 24 hrs, which is the maximum daily amount for this product with other drugs containing acetaminophen 3 or more alcoholic drinks daily while using this product Sore throat warning If sore throat is severe, lasts more than 2 days, occurs with or is followed by fever, headache, rash, nausea, or vomiting, see a doctor promptly. 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. to make a child sleep Ask a doctor before use if you have liver disease glaucoma cough that occurs with too much phlegm (mucus) a breathing problem or chronic cough that lasts or as occurs with smoking, asthma, chronic bronchitis or emphysema trouble urinating due to enlarged 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 do not use more than directed excitability may occur, especially in children marked drowsiness may occur avoid alcoholic drinks be careful when driving a motor vehicle or operating machinery alcohol, sedatives & tranquilizers may increase drowsiness 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 rash or headache that lasts. These could be signs of a serious condition. If pregnant or breast-feeding, ask a health care professional before use. Keep out of reach of children. Overdose warning Taking more than directed can cause serious health problems. In case of overdose, get medical help or contact a Poison Control Center right away. Quick medical attention is critical for adults & for children even if you do not notice any signs or symptoms."],"when_using":["When using this product do not use more than directed excitability may occur, especially in children marked drowsiness may occur avoid alcoholic drinks be careful when driving a motor vehicle or operating machinery alcohol, sedatives & tranquilizers may increase drowsiness"]}