{"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"],"dosage_and_administration_table":["
adults & children 12 yrs & over2 softgels with water every 4 hrs
children 4 to under 12 yrsask a doctor
children under 4 yrsdo not use
"],"effective_time":"20260326","id":"4de87a4e-2502-5f49-e063-6394a90a377e","inactive_ingredient":["Inactive ingredients FD&C blue #1, gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, purified water, shellac, sorbitol sorbitan solution, titanium dioxide"],"indications_and_usage":["Uses 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":["NIGHTTIME SEVERE COLD AND FLU"],"generic_name":["ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL"],"is_original_packager":[true],"manufacturer_name":["CVS HEALTH CORP"],"package_ndc":["51316-526-24"],"product_ndc":["51316-526"],"product_type":["HUMAN OTC DRUG"],"route":["ORAL"],"rxcui":["1297288"],"spl_id":["4de87a4e-2502-5f49-e063-6394a90a377e"],"spl_set_id":["2baa0861-dbef-7910-e063-6394a90a117e"],"substance_name":["PHENYLEPHRINE HYDROCHLORIDE","ACETAMINOPHEN","DEXTROMETHORPHAN HYDROBROMIDE","DOXYLAMINE SUCCINATE"],"unii":["04JA59TNSJ","362O9ITL9D","9D2RTI9KYH","V9BI9B5YI2"]},"package_label_principal_display_panel":["CVS 626T Nighttime Cold & Flu CVS 626T 24ct"],"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 1-877-290-4008"],"set_id":"2baa0861-dbef-7910-e063-6394a90a117e","spl_product_data_elements":["NIGHTTIME SEVERE COLD AND FLU ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL SORBITAN POVIDONE SHELLAC SORBITOL TITANIUM DIOXIDE WATER PROPYLENE GLYCOL POLYETHYLENE GLYCOL, UNSPECIFIED GELATIN GLYCERIN FD&C BLUE NO. 1 PHENYLEPHRINE HYDROCHLORIDE PHENYLEPHRINE ACETAMINOPHEN ACETAMINOPHEN DEXTROMETHORPHAN HYDROBROMIDE DEXTROMETHORPHAN DOXYLAMINE SUCCINATE DOXYLAMINE 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":"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 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"]}