{"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 heart disease high blood pressure thyroid disease diabetes cough with excessive phlegm (mucus) a breathing problem such as emphysema or chronic bronchitis glaucoma difficulty in urination due to enlargement of the prostate gland persistent or chronic cough such as occurs with smoking, asthma, or emphysema"],"ask_doctor_or_pharmacist":["Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin taking sedatives or tranquilizers"],"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 if you have ever had an allergic reaction to this product or any of its ingredients in children under 12 years of age"],"dosage_and_administration":["Directions do not take more than the recommended dose adults & children 12 yrs & over: take 2 softgels with water every 4 hrs. Do not exceed 10 softgels in 24 hours or as directed by a doctor children under 12 yrs: do not use"],"effective_time":"20260826","id":"59fbe7e7-a706-d6a7-e063-6394a90a472e","inactive_ingredient":["Inactive ingredients anhydrous citric acid, FD&C Blue No. 1, FD&C Yellow No. 10, gelatin, glycerin, isopropyl alcohol, mica, N-butyl alcohol, polyethylene glycol-400, propylene glycol, povidone (PVP K30), purified water, shellac, sorbitol solution, titanium dioxide"],"indications_and_usage":["Uses temporarily relieves these symptoms due to a cold or flu: minor aches and pains headache cough nasal and sinus congestion sore throat temporarily reduces 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":["83059-0074-1"],"product_ndc":["83059-0074"],"product_type":["HUMAN OTC DRUG"],"route":["ORAL"],"rxcui":["1297288"],"spl_id":["59fbe7e7-a706-d6a7-e063-6394a90a472e"],"spl_set_id":["70c5517d-be4e-4317-b4f4-df660c71c699"],"substance_name":["ACETAMINOPHEN","DEXTROMETHORPHAN HYDROBROMIDE","DOXYLAMINE SUCCINATE","PHENYLEPHRINE HYDROCHLORIDE"],"unii":["362O9ITL9D","9D2RTI9KYH","V9BI9B5YI2","04JA59TNSJ"],"upc":["0383059000178"]},"other_safety_information":["Other information • store between 20-25°C (68-77°F). Avoid high humidity and excessive heat."],"package_label_principal_display_panel":["PRINCIPAL DISPLAY PANEL mini softgels Nighttime Severe 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"],"set_id":"70c5517d-be4e-4317-b4f4-df660c71c699","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 ANHYDROUS CITRIC ACID FD&C BLUE NO. 1 D&C YELLOW NO. 10 GELATIN GLYCERIN ISOPROPYL ALCOHOL MICA N-BUTYL ALCOHOL POLYETHYLENE GLYCOL 400 PROPYLENE GLYCOL POVIDONE K30 SHELLAC SORBITOL SOLUTION TITANIUM DIOXIDE WATER SNM"],"spl_unclassified_section":["Drug Facts","Distributed by: Shield Pharmaceuticals Corp. Ronkonkoma, NY 11779"],"stop_use":["Stop use and ask a doctor if pain, cough, or nasal congestion 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 nervousness, dizziness, or sleeplessness occurs"],"version":"2","warnings":["Warnings Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take more than 4000 mg of acetaminophen in 24 hours with other drugs containing acetaminophen 3 or more alcoholic drinks daily while using this product Allergy alert: Acetaminophen may cause severe skin or severe allergic reactions. Symptoms may include: skin reddening blisters rash hives facial swelling asthma (wheezing) shock. If a skin or general allergic 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 is followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly. Do not use in children or to sedate children."],"when_using":["When using this product do not exceed recommended dosage may cause marked drowsiness avoid alcoholic drinks alcohol, sedatives, and tranquilizers may increase drowsiness be careful when driving a motor vehicle or operating machinery excitability may occur, especially in children"]}