{"active_ingredient":["Active ingredient (in each softgel) Acetaminophen 325 mg Dextromethorphan HBr 15 mg Doxylamine succinate 6.25 mg Phenylephrine HCl - 5 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."],"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 6 hrs • children 4 to under 12 yrs ask a doctor • children under 4 yrs do not use"],"effective_time":"20251031","id":"4279e8f6-12b1-b3c3-e063-6394a90a54cf","inactive_ingredient":["Inactive ingredients FD&C Blue No. 1, FD&C Red No. 40, FD&C Yellow No. 10, gelatin, glycerin, isopropyl alcohol, MCT Oil, polyethylene glycol-400, propylene glycol, povidone, purified water, silver sheen, sorbitol solution"],"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. In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away. Quick medical attention is critical for adults & for children even if you do not notice any signs or symptoms."],"openfda":{"application_number":["M012"],"brand_name":["Nighttime Cold and Flu Max Softgels"],"generic_name":["ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL"],"is_original_packager":[true],"manufacturer_name":["Topco Associates, LLC"],"package_ndc":["76162-913-24"],"product_ndc":["76162-913"],"product_type":["HUMAN OTC DRUG"],"route":["ORAL"],"spl_id":["4279e8f6-12b1-b3c3-e063-6394a90a54cf"],"spl_set_id":["787bff76-0ee2-4e7e-b908-876e4a3e3bfc"],"substance_name":["ACETAMINOPHEN","DEXTROMETHORPHAN HYDROBROMIDE","DOXYLAMINE SUCCINATE","PHENYLEPHRINE HYDROCHLORIDE"],"unii":["362O9ITL9D","9D2RTI9KYH","V9BI9B5YI2","04JA59TNSJ"]},"other_safety_information":["Other information • store between 20-25°C (68-77°F). Avoid high humidity and excessive heat. Protect from light."],"package_label_principal_display_panel":["PRINCIPAL DISPLAY PANEL Nighttime Cold & Flu Max Softgels Carton Nighttime minis"],"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? 1-800-373-6981 (toll-free)"],"set_id":"787bff76-0ee2-4e7e-b908-876e4a3e3bfc","spl_product_data_elements":["Nighttime Cold and Flu Max Softgels Acetaminophen, Dextromethorphan HBr, Doxylamine succinate, Phenylephrine HCl BUTYLATED HYDROXYANISOLE FD&C BLUE NO. 1 GELATIN GLYCERIN METHYLPARABEN POLYETHYLENE GLYCOL 400 PROPYLENE GLYCOL PROPYLPARABEN POVIDONE SORBITOL WATER ACETAMINOPHEN ACETAMINOPHEN DEXTROMETHORPHAN HYDROBROMIDE DEXTROMETHORPHAN DOXYLAMINE SUCCINATE DOXYLAMINE PHENYLEPHRINE HYDROCHLORIDE PHENYLEPHRINE SD15"],"spl_unclassified_section":["Drug Facts","Distributed by: Topco Associates LLC Itasca, IL 60143"],"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 • new symptoms occur • cough comes back or occurs with rash or headache that lasts. These could be signs of a serious condition."],"version":"4","warnings":["Warnings Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take • more than 8 Softgels 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 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 n 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"]}