{"active_ingredient":["Active ingredients (in each softgel) Acetaminophen 325mg Dextromethorphan HBr 15mg 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 last 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 the blood thinning drug warfarin taking sedative or tranquilizers."],"do_not_use":["Do not use: 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. with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist"],"dosage_and_administration":["Directions ■ take only as directed- see OVERDOSE WARNING ■ do not exceed 8 softgels per 24 hrs. ■ take softgels with water Adults and children age 12 yrs and over 2 softgels every 6 hrs. Children 4 to under 12 yrs ask a doctor Children under 4 yrs do not use"],"dosage_and_administration_table":["<table width=\"100%\"><caption/><tbody><tr><td> Adults and children age 12 yrs and over</td><td>2 softgels every 6 hrs. </td></tr><tr><td> Children 4 to under 12 yrs </td><td> ask a doctor</td></tr><tr><td> Children under 4 yrs</td><td> do not use</td></tr></tbody></table>"],"effective_time":"20250520","id":"926db391-146a-4f73-9f00-48ebde363099","inactive_ingredient":["Inactive ingredients Polyethylene Glycol400, Propylene Glycol, Povidone (PVP K-30),Purified water, Gelatin, Glycerin, Sorbitol Sorbitan solution, FD & C Blue No. 1, D &C Yellow No.10"],"indications_and_usage":["Uses: temporarily relieves these common cold/flu symptoms: ■ minor aches & pains ■ headache ■ sore throat ■ fever ■ Runny nose and sneezing ■ cough due to minor throat & bronchial irritation"],"keep_out_of_reach_of_children":["Keep out of reach of children."],"openfda":{"application_number":["M012"],"brand_name":["Nuvicare NightTime Cold and Flu Softgel"],"generic_name":["ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE"],"is_original_packager":[true],"manufacturer_name":["NUVICARE LLC"],"package_ndc":["84324-019-01"],"product_ndc":["84324-019"],"product_type":["HUMAN OTC DRUG"],"route":["ORAL"],"rxcui":["1094549"],"spl_id":["926db391-146a-4f73-9f00-48ebde363099"],"spl_set_id":["37a88914-6234-4191-86f5-103c396c52af"],"substance_name":["ACETAMINOPHEN","DEXTROMETHORPHAN HYDROBROMIDE","DOXYLAMINE SUCCINATE"],"unii":["362O9ITL9D","9D2RTI9KYH","V9BI9B5YI2"],"upc":["0384324000183"]},"overdosage":["Overdose warning: In case of overdose, get medical help or contact a Poison Control Center right away. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms. (1-800-222-1222)"],"package_label_principal_display_panel":["PP0130-01 NC(nosymbol)-Nighttime Cold+Flu Soft Gels-10ct"],"pregnancy_or_breast_feeding":["If pregnant or breast-feeding, ask a health professional before use."],"purpose":["Purpose Acetaminophen 325mg.....................Pain reliever/fever reducer Dextromethorphan HBr 15mg..................... Cough suppressant Doxylamine succinate 6.25 mg ............................. Antihistamine"],"questions":["Questions or Comments? Call 1-718-337-8733 or email: support@nuvicare.com"],"set_id":"37a88914-6234-4191-86f5-103c396c52af","spl_product_data_elements":["Nuvicare NightTime Cold and Flu Softgel ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, Doxylamine succinate ACETAMINOPHEN ACETAMINOPHEN DEXTROMETHORPHAN HYDROBROMIDE DEXTROMETHORPHAN DOXYLAMINE SUCCINATE DOXYLAMINE POLYETHYLENE GLYCOL 400 PROPYLENE GLYCOL POVIDONE Gelatin Sorbitol GLYCERIN FD&C BLUE NO. 1 D&C YELLOW NO. 10 Oblong SD15"],"spl_unclassified_section":["Drug Facts","Distributed by: Nuvicare LLC, Brooklyn, NY 11211, USA"],"stop_use":["Stop use and ask a doctor if pain or cough get worse or lasts more than 7 days new symptoms occur fever gets worse or lasts more than 3 days redness or swelling is present 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 between 15-30°C (59 to 86 °F) ■ avoid excessive heat"],"version":"1","warnings":["Warning 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 everyday while using this product. Allergy Alert: acetamenophen may cause severe skin recations. Symptoms may include: ■ skin reddening ■ blisters ■ rash. if a skin reactions 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 exceed recommeded dosage. excitability may occur, especially in children marked drowsiness may occur avoid alcoholic drinks alcohol, sedative and tranquilizers may increase drowsiness be careful when driving a motor vehicle or operating machinery"]}