{"active_ingredient":["Active ingredients (in each capsule) Acetaminophen 325 mg Dextromethorphan hydrobromide 10 mg Phenylephrine hydrochloride 5 mg","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 ● cough with excessive phlegm (mucus) ● difficulty in urination due to enlargement of the prostate gland ● persistent or chronic cough such as occurs with smoking, asthma, or emphysema","Ask a doctor before use if you have ● liver disease ● heart disease ● high blood pressure ● thyroid disease ● diabetes ● glaucoma ● cough with excessive phlegm (mucus) ● a breathing problem such as emphysema or chronic bronchitis ● 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","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","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":"20251204","id":"45267d3d-4c7e-c05a-e063-6394a90abc41","inactive_ingredient":["Inactive ingredients FD&C yellow #6, FD&C red #40, gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, purified water, shellac, sodium hydroxide, sorbitol sorbitan solution, titanium dioxide","Inactive ingredients FD&C blue #1, D&C yellow #10, gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, purified water, shellac, sodium hydroxide, sorbitol sorbitan solution, titanium dioxide"],"indications_and_usage":["Uses · temporarily relieves these symptoms due to a cold or flu: · nasal congestion · sinus congestion and pressure · headache · minor aches and pains · cough · sore throat · helps clear nasal passages and shrinks swollen membranes · temporarily reduces fever","Uses · temporarily relieves these symptoms due to a cold or flu: · nasal congestion · sinus congestion and pressure · headache · minor aches and pains · cough · sore throat · runny nose · sneezing · helps clear nasal passages and shrinks swollen membranes · 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.","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 Plus Maximum Strength Severe Sinus Congestion and Cough Day and Night"],"generic_name":["ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDE"],"is_original_packager":[true],"manufacturer_name":["Bayer HealthCare LLC."],"package_ndc":["0280-1610-20"],"product_ndc":["0280-1610"],"product_type":["HUMAN OTC DRUG"],"route":["ORAL"],"rxcui":["1086997","1297288","2634363"],"spl_id":["45267d3d-4c7e-c05a-e063-6394a90abc41"],"spl_set_id":["52542774-fd05-640c-e054-00144ff8d46c"],"upc":["0016500555322"]},"other_safety_information":["Other information Other information · store at room temperature. Avoid excessive heat above 40ºC (104ºF).","Other information Other information · store at room temperature. Avoid excessive heat above 40ºC (104ºF)."],"package_label_principal_display_panel":["PDP PDP Carton 20 count 1"],"pregnancy_or_breast_feeding":["If pregnant or breast-feeding, ask a health professional before use.","If pregnant or breast-feeding , ask a health professional before use."],"purpose":["Purposes Pain reliever/fever reducer Cough suppressant Nasal decongestant",""],"questions":["Questions or comments? Questions or comments? 1-800-986-0369 (Mon-Fri 9AM –5PM EST)","Questions or comments? Questions or comments? 1-800-986-0369 (Mon-Fri 9AM - 5PM EST)"],"set_id":"52542774-fd05-640c-e054-00144ff8d46c","spl_product_data_elements":["Alka-Seltzer Plus Maximum Strength Severe Sinus Congestion and Cough Day and Night Acetaminophen, Dextromethorphan hydrobromide, Doxylamine succinate, Phenylephrine hydrochloride Alka-Seltzer Plus Maximum Strength Severe Sinus Congestion and Cough Day Acetaminophen, Dextromethorphan hydrobromide, Phenylephrine hydrochloride SORBITOL ACETAMINOPHEN ACETAMINOPHEN DEXTROMETHORPHAN HYDROBROMIDE DEXTROMETHORPHAN WATER SHELLAC SORBITAN TITANIUM DIOXIDE PHENYLEPHRINE HYDROCHLORIDE PHENYLEPHRINE FD&C YELLOW NO. 6 FD&C RED NO. 40 GLYCERIN GELATIN POLYETHYLENE GLYCOL, UNSPECIFIED POVIDONE PROPYLENE GLYCOL SODIUM HYDROXIDE AS;SC Alka-Seltzer Plus Maximum Strength Severe Sinus Congestion and Cough Night Acetaminophen, Dextromethorphan hydrobromide, Doxylamine succinate, Phenylephrine hydrochloride PHENYLEPHRINE HYDROCHLORIDE PHENYLEPHRINE WATER ACETAMINOPHEN ACETAMINOPHEN DEXTROMETHORPHAN HYDROBROMIDE DEXTROMETHORPHAN DOXYLAMINE SUCCINATE DOXYLAMINE FD&C BLUE NO. 1 D&C YELLOW NO. 10 GELATIN GLYCERIN SHELLAC SODIUM HYDROXIDE TITANIUM DIOXIDE POVIDONE POLYETHYLENE GLYCOL, UNSPECIFIED SORBITOL SORBITAN AS;SC"],"spl_unclassified_section":["Do not take these products at the same time.","Drug Facts","Alka-Seltzer Plus® Maximum Strength Severe Sinus Congestion & Cough Day Liquid Gels","Alka-Seltzer Plus® Maximum Strength Severe Sinus Congestion & Cough Night Liquid Gels","Drug Facts"],"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","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":"6","warnings":["Warnings Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take · more than 4,000 mg of acetaminophen in 24 hours · 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.","Warnings Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take · more than 4,000 mg of acetaminophen in 24 hours · 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","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"]}