{"active_ingredient":["Active ingredients (in each capsule) Acetaminophen 325 mg Dextromethorphan hydrobromide 10 mg Doxylamine succinate 6.25 mg Phenylephrine hydrochloride 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 excessive phlegm (mucus) ● persistent or chronic cough such as occurs with smoking, asthma, or emphysema ● a breathing problem such as emphysema or chronic bronchitis ● difficulty in urination due to enlargement of the prostate gland"],"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 Directions · do not take more than the recommended dose · adults and children 12 years and over: take 2 capsules with water every 4 hours. Do not exceed 10 capsules in 24 hours or as directed by a doctor. · children under 12 years: do not use"],"effective_time":"20260508","id":"5150ff85-85ba-9cd9-e063-6294a90a1144","inactive_ingredient":["Inactive ingredients D&C yellow No. 10, FD&C blue No. 1, gelatin, glycerin, polyethylene glycol, potassium aluminum silicate, povidone, propylene glycol, purified water, shellac, sodium hydroxide, sorbitol sorbitan solution, titanium dioxide"],"indications_and_usage":["Uses Uses · temporarily relieves these symptoms due to a cold or flu: · minor aches and pains · headache · cough · sore throat · runny nose · sneezing · sinus congestion and pressure · nasal congestion · temporarily reduces fever"],"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. 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":["ALKA SELTZER COLD Cold Flu and Congestion Severe Night Fast Gels"],"generic_name":["ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDE"],"is_original_packager":[true],"manufacturer_name":["Bayer HealthCare LLC."],"package_ndc":["0280-8282-24"],"product_ndc":["0280-8282"],"product_type":["HUMAN OTC DRUG"],"route":["ORAL"],"rxcui":["1297288"],"spl_id":["5150ff85-85ba-9cd9-e063-6294a90a1144"],"spl_set_id":["5150ff85-85bb-9cd9-e063-6294a90a1144"],"substance_name":["PHENYLEPHRINE HYDROCHLORIDE","ACETAMINOPHEN","DEXTROMETHORPHAN HYDROBROMIDE","DOXYLAMINE SUCCINATE"],"unii":["04JA59TNSJ","362O9ITL9D","9D2RTI9KYH","V9BI9B5YI2"],"upc":["0016500576822"]},"other_safety_information":["Other information Other information ● store at room temperature. Avoid excessive heat above 40°C (104°F)."],"package_label_principal_display_panel":["PDP"],"pregnancy_or_breast_feeding":["If pregnant or breast-feeding, ask a health professional before use."],"purpose":["Purposes Pain reliever/fever reducer Cough suppressant Antihistamine Nasal decongestant"],"questions":["Questions or comments? Questions or comments? 1-800-986-0369 (Mon-Fri 8AM - 8PM EST)"],"set_id":"5150ff85-85bb-9cd9-e063-6294a90a1144","spl_product_data_elements":["ALKA SELTZER COLD Cold Flu and Congestion Severe Night Fast Gels acetaminophen, dextromethorphan hydrobromide, doxylamine succinate, phenylephrine hydrochloride D&C YELLOW NO. 10 GELATIN POVIDONE PROPYLENE GLYCOL PHENYLEPHRINE HYDROCHLORIDE PHENYLEPHRINE SORBITOL SHELLAC SODIUM HYDROXIDE SORBITAN TITANIUM DIOXIDE WATER GLYCERIN POLYETHYLENE GLYCOL, UNSPECIFIED FD&C BLUE NO. 1 ACETAMINOPHEN ACETAMINOPHEN DEXTROMETHORPHAN HYDROBROMIDE DEXTROMETHORPHAN DOXYLAMINE SUCCINATE DOXYLAMINE ASP;N"],"spl_unclassified_section":["Drug Facts"],"stop_use":["Stop use and ask a doctor if 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":"1","warnings":["Warnings Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take · more than 10 capsules 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 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 followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly. Do not use to sedate children."],"when_using":["When using this product ● do not exceed recommended dosage ● may cause marked drowsiness ● alcohol, sedatives, and tranquilizers may increase the drowsiness effect ● avoid alcoholic drinks ● be careful when driving a motor vehicle or operating machinery ● excitability may occur, especially in children"]}