{"active_ingredient":["Active ingredients( in each softgel) Acetaminophen 325 mg Dextromethorphan HBr 10 mg Doxylamine succinate 6.25 mg Phenylephrine HCl 5 mg"],"ask_doctor":["Ask a doctor before use if you have • liver disease • heart disease • high blood pressure • thyroid disease • diabetes • 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."],"dosage_and_administration":["Directions take only as directed do not exceed 8 softgels 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"],"effective_time":"20240925","id":"22ef568c-f6b3-924e-e063-6394a90a2d16","inactive_ingredient":["FD&C blue #1, gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, purified water, shellac, sorbitol sorbitan solution, titanium dioxide"],"indications_and_usage":["temporarily relieves common cold/flu symptoms: nasal congestion sinus congestion & pressure cough due to minor throat & bronchial irritation cough to help you sleep minor aches & pains headache fever sore throat runny nose & sneezing reduces swelling of nasal passages temporarily restores freer breathing through the nose promotes nasal and/or sinus drainage"],"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 (1-800-222-1222). Quick 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":["COLD AND FLU NIGHTTIME SEVERE"],"generic_name":["ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL"],"is_original_packager":[true],"manufacturer_name":["TARGET CORP"],"package_ndc":["11673-983-08","11673-983-24"],"product_ndc":["11673-983"],"product_type":["HUMAN OTC DRUG"],"route":["ORAL"],"rxcui":["1297288"],"spl_id":["22ef568c-f6b3-924e-e063-6394a90a2d16"],"spl_set_id":["9de9c34e-a0ca-cdf9-e053-2a95a90a93d3"],"substance_name":["PHENYLEPHRINE HYDROCHLORIDE","ACETAMINOPHEN","DEXTROMETHORPHAN HYDROBROMIDE","DOXYLAMINE SUCCINATE"],"unii":["04JA59TNSJ","362O9ITL9D","9D2RTI9KYH","V9BI9B5YI2"]},"package_label_principal_display_panel":["626T-NYSev Cold and Flu-24ct_IFC"],"pregnancy_or_breast_feeding":["If pregnant or breast-feeding, ask a health professional before use."],"purpose":["Purpose Pain reliever/fever reducer Cough suppressant Antihistamine Nasal decongestant"],"questions":["Questions or comments? Call 1-800-910-6874"],"set_id":"9de9c34e-a0ca-cdf9-e053-2a95a90a93d3","spl_product_data_elements":["COLD AND FLU NIGHTTIME SEVERE ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL POVIDONE SHELLAC SORBITOL TITANIUM DIOXIDE WATER PHENYLEPHRINE HYDROCHLORIDE PHENYLEPHRINE ACETAMINOPHEN ACETAMINOPHEN DEXTROMETHORPHAN HYDROBROMIDE DEXTROMETHORPHAN PROPYLENE GLYCOL POLYETHYLENE GLYCOL, UNSPECIFIED DOXYLAMINE SUCCINATE DOXYLAMINE GELATIN GLYCERIN FD&C BLUE NO. 1 72"],"spl_unclassified_section":["Drug Facts"],"stop_use":["Stop use and ask a doctor if • you get nervous, dizzy or sleepless • pain, nasal congestion 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 • do not exceed 25°C"],"version":"4","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 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."],"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, and tranquilizers may increase drowsiness"]}