{"active_ingredient":["Acetaminophen 500 mg Pseudoephedrine HCl 30 mg"],"ask_doctor":["Ask a doctor before use if you have ■ liver disease ■ heart disease ■ high blood pressure ■ thyroid disease ■ diabetes ■ trouble urinating due to an enlarged prostate gland"],"ask_doctor_or_pharmacist":["Ask a doctor or pharmacist before use if you are 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. ■ if you have ever had an allergic reaction to this product or any of its ingredients"],"dosage_and_administration":["Directions ■ do not take more than directed (see overdose warning) adults and children 12 years and over ■ take 2 caplets every 6 hours while symptoms last ■ do not take more than 6 caplets in 24 hours, unless directed by a doctor ■ do not use for more than 10 days unless directed by a doctor children under 12 years ask a doctor"],"dosage_and_administration_table":["<table border=\"0\"><tbody><tr><td>adults and children   12 years and over </td><td>&#x25A0; take 2 caplets every 6 hours while symptoms last   &#x25A0; do not take more than 6 caplets in 24 hours, unless   directed by a doctor   &#x25A0; do not use for more than 10 days unless directed   by a doctor </td></tr><tr><td>children under 12 years</td><td>ask a doctor</td></tr></tbody></table>"],"effective_time":"20260610","id":"537e1a0d-820e-c3f7-e063-6294a90a56ea","inactive_ingredient":["Inactive ingredients candelilla wax, croscarmellose sodium, crospovidone, FD&C yellow no. 6 aluminum lake, hypromellose, microcrystalline cellulose, polyethylene glycol, povidone, pregelatinized starch, titanium dioxide, zinc stearate"],"indications_and_usage":["Uses ■ temporarily relieves these common cold/flu symptoms: ■ minor aches and pains ■ headache ■ sore throat ■ nasal congestion ■ sinus congestion and pressure ■ helps clear nasal passages ■ promotes nasal and sinus drainage ■ temporarily reduces fever"],"keep_out_of_reach_of_children":["Keep out of reach of children."],"openfda":{"application_number":["M012"],"brand_name":["Sudafed Sinus Congestion Plus Cold Severe Day"],"generic_name":["ACETAMINOPHEN, PSEUDOEPHEDRINE"],"is_original_packager":[true],"manufacturer_name":["Kenvue Brands LLC"],"package_ndc":["50580-659-10"],"product_ndc":["50580-659"],"product_type":["HUMAN OTC DRUG"],"route":["ORAL"],"rxcui":["1090743"],"spl_id":["537e1a0d-820e-c3f7-e063-6294a90a56ea"],"spl_set_id":["537e1a0d-820d-c3f7-e063-6294a90a56ea"],"substance_name":["PSEUDOEPHEDRINE HYDROCHLORIDE","ACETAMINOPHEN"],"unii":["6V9V2RYJ8N","362O9ITL9D"],"upc":["0300450114105"]},"package_label_principal_display_panel":["PRINCIPAL DISPLAY PANEL NEW NDC 50580-659-10 SUDAFED ® SINUS CONGESTION + COLD SEVERE Acetaminophen, Pseudoephedrine HCI, Pain Reliever/Fever Reducer, Nasal Decongestant • SINUS PRESSURE + CONGESTION • FEVER • HEAD + BODY ACHES actual size NON-DROWSY 10 TABLETS sudafed-1.jpg"],"pregnancy_or_breast_feeding":["If pregnant or breast-feeding , ask a health professional before use."],"purpose":["Pain reliever/fever reducer Nasal decongestant"],"questions":["Questions or comments? call 1-888-217-2117 (toll-free) or 215-273-8755 (collect)"],"set_id":"537e1a0d-820d-c3f7-e063-6294a90a56ea","spl_product_data_elements":["Sudafed Sinus Congestion Plus Cold Severe Day Acetaminophen, Pseudoephedrine MICROCRYSTALLINE CELLULOSE TITANIUM DIOXIDE CANDELILLA WAX CROSPOVIDONE, UNSPECIFIED POVIDONE, UNSPECIFIED POLYETHYLENE GLYCOL, UNSPECIFIED PSEUDOEPHEDRINE HYDROCHLORIDE PSEUDOEPHEDRINE ZINC STEARATE ACETAMINOPHEN ACETAMINOPHEN CROSCARMELLOSE SODIUM FD&C YELLOW NO. 6 ALUMINUM LAKE HYPROMELLOSE, UNSPECIFIED DT;C"],"spl_unclassified_section":["Drug Facts"],"stop_use":["Stop use and ask a doctor if ■ nervousness, dizziness, or sleeplessness occur ■ pain 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 These could be signs of a serious condition."],"storage_and_handling":["Other information ■ store between 20 - 25°C (68 - 77°F) ■ do not use if blister unit is torn or broken"],"version":"1","warnings":["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 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. 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 Ask a doctor before use if you have ■ liver disease ■ heart disease ■ high blood pressure ■ thyroid disease ■ diabetes ■ trouble urinating due to an enlarged prostate gland Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin When using this product do not exceed recommended dose Stop use and ask a doctor if ■ nervousness, dizziness, or sleeplessness occur ■ pain 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 These could be signs of a serious condition. If pregnant or breast-feeding , ask a health professional before use. Keep out of reach of children. Overdose warning In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222) Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms."],"when_using":["When using this product do not exceed recommended dose"]}