{"active_ingredient":["Active ingredients Active ingredients (in each tablet) Purpose Acetaminophen 500 mg Pain reliever/fever reducer Pseudoephedrine HCl 30 mg Nasal decongestant","Active ingredients Active ingredients (in each tablet) Purpose Acetaminophen 500 mg Pain reliever/fever reducer Diphenhydramine HCl 25 mg Antihistamine Pseudoephedrine HCl 30 mg Nasal decongestant"],"active_ingredient_table":["
Active ingredients (in each tablet)Purpose
Acetaminophen 500 mgPain reliever/fever reducer
Pseudoephedrine HCl 30 mgNasal decongestant
","
Active ingredients (in each tablet)Purpose
Acetaminophen 500 mgPain reliever/fever reducer
Diphenhydramine HCl 25 mgAntihistamine
Pseudoephedrine HCl 30 mgNasal decongestant
"],"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 ■ a breathing problem such as emphysema or chronic bronchitis ■ glaucoma"],"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. ■ with any other product containing diphenhydramine, even one used on skin ■ 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","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":["
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 yearsask a doctor
","
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 yearsask a doctor
"],"effective_time":"20260610","id":"5382e4cc-3fc5-359e-e063-6394a90a169b","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","Inactive ingredients candelilla wax, croscarmellose sodium, crospovidone, FD&C blue no. 1 aluminum lake, hypromellose, microcrystalline cellulose, polyethylene glycol, povidone, pregelatinized starch, silicon dioxide, 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","Uses ■ temporarily relieves these common cold/flu symptoms: ■ minor aches and pains ■ headache ■ sore throat ■ nasal congestion ■ sinus congestion and pressure ■ sneezing and runny nose ■ helps clear nasal passages ■ temporarily reduces fever"],"keep_out_of_reach_of_children":["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 and Night"],"generic_name":["ACETAMINOPHEN, DIPHENHYDRAMINE, PSEUDOEPHEDRINE"],"is_original_packager":[true],"manufacturer_name":["Kenvue Brands LLC"],"package_ndc":["50580-660-16"],"product_ndc":["50580-660"],"product_type":["HUMAN OTC DRUG"],"route":["ORAL"],"rxcui":["1090743","1291711","2744979"],"spl_id":["5382e4cc-3fc5-359e-e063-6394a90a169b"],"spl_set_id":["5382dcad-0337-4440-e063-6394a90a706e"],"upc":["0300450114006"]},"package_label_principal_display_panel":["PRINCIPAL DISPLAY PANEL NEW NDC 50580-660-16 SUDAFED SINUS CONGESTION + COLD SEVERE Acetaminophen, Pseudoephedrine HCI, Pain Reliever/Fever Reducer, Nasal Decongestant DAYTIME • SINUS PRESSURE + CONGESTION • FEVER • HEAD + BODY ACHES actual size Acetaminophen, Diphenhydramine HCI, Pseudoephedrine HCI, Pain Reliever/Fever Reducer, Antihistamine, Nasal Decongestant NIGHTTIME • SINUS PRESSURE + CONGESTION • FEVER • HEAD + BODY ACHES • RUNNY NOSE • SNEEZING actual size 12 TABLETS; 4 TABLETS; 16 TABLETS TOTAL sudafed-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":["Active ingredients (in each tablet) Purpose Acetaminophen 500 mg Pain reliever/fever reducer Pseudoephedrine HCl 30 mg Nasal decongestant","Active ingredients (in each tablet) Purpose Acetaminophen 500 mg Pain reliever/fever reducer Diphenhydramine HCl 25 mg Antihistamine Pseudoephedrine HCl 30 mg Nasal decongestant"],"purpose_table":["
Active ingredients (in each tablet)Purpose
Acetaminophen 500 mgPain reliever/fever reducer
Pseudoephedrine HCl 30 mgNasal decongestant
","
Active ingredients (in each tablet)Purpose
Acetaminophen 500 mgPain reliever/fever reducer
Diphenhydramine HCl 25 mgAntihistamine
Pseudoephedrine HCl 30 mgNasal decongestant
"],"questions":["Questions or comments? call 1-888-217-2117 (toll-free) or 215-273-8755 (collect)","Questions or comments? call 1-888-217-2117 (toll-free) or 215-273-8755 (collect)"],"set_id":"5382dcad-0337-4440-e063-6394a90a706e","spl_product_data_elements":["Sudafed Sinus Congestion plus Cold Severe Day and Night Acetaminophen, Diphenhydramine, Pseudoephedrine Sudafed Sinus Congestion plus Cold Severe Night Acetaminophen, Pseudoephedrine, Diphenhydramine SILICON DIOXIDE CANDELILLA WAX CROSCARMELLOSE SODIUM CROSPOVIDONE, UNSPECIFIED FD&C BLUE NO. 1 ALUMINUM LAKE ACETAMINOPHEN ACETAMINOPHEN PSEUDOEPHEDRINE HYDROCHLORIDE PSEUDOEPHEDRINE HYPROMELLOSE, UNSPECIFIED MICROCRYSTALLINE CELLULOSE POLYETHYLENE GLYCOL, UNSPECIFIED POVIDONE ZINC STEARATE TITANIUM DIOXIDE DIPHENHYDRAMINE HYDROCHLORIDE DIPHENHYDRAMINE NT;C Sudafed Sinus Congestion plus Cold Severe Day Acetaminophen, Pseudoephedrine CANDELILLA WAX CROSCARMELLOSE SODIUM CROSPOVIDONE, UNSPECIFIED FD&C YELLOW NO. 6 ALUMINUM LAKE ACETAMINOPHEN ACETAMINOPHEN PSEUDOEPHEDRINE HYDROCHLORIDE PSEUDOEPHEDRINE HYPROMELLOSE, UNSPECIFIED MICROCRYSTALLINE CELLULOSE POLYETHYLENE GLYCOL, UNSPECIFIED POVIDONE ZINC STEARATE TITANIUM DIOXIDE DT;C"],"spl_unclassified_section":["SUDAFED® SINUS CONGESTION + COLD SEVERE DAY Drug Facts","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.","EXTRA STRENGTH TYLENOL® SEVERE COUGH + SORE THROAT NIGHT Drug Facts","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."],"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.","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 ​","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.","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. ■ with any other product containing diphenhydramine, even one used on skin ■ 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 ■ a breathing problem such as emphysema or chronic bronchitis ■ glaucoma Ask a doctor or pharmacist before use if you are ■ taking the blood thinning drug warfarin ■ taking sedatives or tranquilizers When using this product ■ do not exceed recommended dose ■ excitability may occur, especially in children ■ marked drowsiness may occur ■ alcohol, sedatives and tranquilizers may increase drowsiness ■ avoid alcoholic drinks ■ be careful when driving a motor vehicle or operating machinery 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."],"when_using":["When using this product do not exceed recommended dose","When using this product ■ do not exceed recommended dose ■ excitability may occur, especially in children ■ marked drowsiness may occur ■ alcohol, sedatives and tranquilizers may increase drowsiness ■ avoid alcoholic drinks ■ be careful when driving a motor vehicle or operating machinery"]}