{"active_ingredient":["Active ingredient (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 •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":"20260714","id":"5694ef33-3162-41ed-e063-6294a90ac154","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 Severe Cold and Flu Maximum Strength mini softgels"],"generic_name":["ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL"],"is_original_packager":[true],"manufacturer_name":["Shield Pharmaceuticals Corp"],"package_ndc":["83059-0095-1"],"product_ndc":["83059-0095"],"product_type":["HUMAN OTC DRUG"],"route":["ORAL"],"rxcui":["1297288"],"spl_id":["5694ef33-3162-41ed-e063-6294a90ac154"],"spl_set_id":["5fa848ef-35ee-4e05-8ff2-781d034cf6ac"],"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 mini softgels Severe Nighttime Cold & Flu Maximum Strength 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":"5fa848ef-35ee-4e05-8ff2-781d034cf6ac","spl_product_data_elements":["Nighttime Severe Cold and Flu Maximum Strength mini softgels Acetaminophen, Dextromethorphan HBr, Doxylamine succinate, Phenylephrine HCl ACETAMINOPHEN ACETAMINOPHEN DEXTROMETHORPHAN HYDROBROMIDE DEXTROMETHORPHAN DOXYLAMINE SUCCINATE DOXYLAMINE PHENYLEPHRINE HYDROCHLORIDE PHENYLEPHRINE PROPYLPARABEN POVIDONE SORBITOL SOLUTION WATER FD&C BLUE NO. 1 FD&C RED NO. 40 D&C YELLOW NO. 10 GELATIN GLYCERIN ISOPROPYL ALCOHOL MEDIUM-CHAIN TRIGLYCERIDES POLYETHYLENE GLYCOL 400 PROPYLENE GLYCOL SNM"],"spl_unclassified_section":["Drug Facts","Distributed by: Shield Pharmaceuticals Corp. Ronkonkoma, NY 11779"],"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"]}