{ "meta": { "disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.", "terms": "https://open.fda.gov/terms/", "license": "https://open.fda.gov/license/", "last_updated": "2026-06-02", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "spl_product_data_elements": [ "EXTRA STRENGTH TYLENOL SEVERE COUGH PLUS SORE THROAT DAY/NIGHT Acetaminophen, Dextromethorphan hydrobromide, Chlorpheniramine Maleate TYLENOL Acetaminophen and Dextromethorphan Hydrobromide PROPYLENE GLYCOL POWDERED CELLULOSE SODIUM STARCH GLYCOLATE TYPE A TITANIUM DIOXIDE ACETAMINOPHEN ACETAMINOPHEN DEXTROMETHORPHAN HYDROBROMIDE DEXTROMETHORPHAN CARNAUBA WAX HYPROMELLOSE, UNSPECIFIED MAGNESIUM STEARATE MICROCRYSTALLINE CELLULOSE TY;COLD;1409 TYLENOL Acetaminophen, Dextromethorphan Hydrobromide, and Chlorpheniramine Maleate POWDERED CELLULOSE TRIACETIN FD&C BLUE NO. 1 ALUMINUM LAKE POLYDEXTROSE HYPROMELLOSE, UNSPECIFIED MAGNESIUM STEARATE MICROCRYSTALLINE CELLULOSE POLYETHYLENE GLYCOL, UNSPECIFIED TITANIUM DIOXIDE ACETAMINOPHEN ACETAMINOPHEN DEXTROMETHORPHAN HYDROBROMIDE DEXTROMETHORPHAN CHLORPHENIRAMINE MALEATE CHLORPHENIRAMINE CARNAUBA WAX SODIUM STARCH GLYCOLATE TYPE A TY;COLD;1410" ], "spl_unclassified_section": [ "EXTRA STRENGTH TYLENOL® SEVERE COUGH + SORE THROAT DAY Drug Facts", "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." ], "active_ingredient": [ "Active ingredients (in each caplet) Purpose Acetaminophen 500 mg Pain reliever/fever reducer Dextromethorphan HBr 15 mg Cough suppressant", "Active ingredients (in each caplet) Purpose Acetaminophen 500 mg Pain reliever/fever reducer Chlorpheniramine maleate 2 mg Antihistamine Dextromethorphan HBr 15 mg Cough suppressant" ], "active_ingredient_table": [ "
Active ingredients (in each caplet)Purpose
Acetaminophen 500 mgPain reliever/fever reducer
Dextromethorphan HBr 15 mgCough suppressant
", "
Active ingredients (in each caplet)Purpose
Acetaminophen 500 mgPain reliever/fever reducer
Chlorpheniramine maleate 2 mgAntihistamine
Dextromethorphan HBr 15 mgCough suppressant
" ], "purpose": [ "Active ingredients (in each caplet) Purpose Acetaminophen 500 mg Pain reliever/fever reducer Dextromethorphan HBr 15 mg Cough suppressant", "Active ingredients (in each caplet) Purpose Acetaminophen 500 mg Pain reliever/fever reducer Chlorpheniramine maleate 2 mg Antihistamine Dextromethorphan HBr 15 mg Cough suppressant" ], "purpose_table": [ "
Active ingredients (in each caplet)Purpose
Acetaminophen 500 mgPain reliever/fever reducer
Dextromethorphan HBr 15 mgCough suppressant
", "
Active ingredients (in each caplet)Purpose
Acetaminophen 500 mgPain reliever/fever reducer
Chlorpheniramine maleate 2 mgAntihistamine
Dextromethorphan HBr 15 mgCough suppressant
" ], "indications_and_usage": [ "Uses ■ temporarily relieves these common cold/flu symptoms: ■ minor aches and pains ■ headache ■ sore throat ■ cough ■ temporarily reduces fever", "Uses ■ temporarily relieves these common cold/flu symptoms: ■ minor aches and pains ■ headache ■ sore throat ■ cough ■ sneezing and runny nose ■ temporarily reduces fever" ], "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 ■ persistent or chronic cough such as occurs with smoking, asthma or emphysema ■ cough that occurs with too much phlegm (mucus) 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 ■ pain or cough 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. 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.", "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 ■ a breathing problem such as emphysema or chronic bronchitis ■ glaucoma ■ trouble urinating due to an enlarged prostate gland ■ persistent or chronic cough such as occurs with smoking, asthma or emphysema ■ cough that occurs with too much phlegm (mucus) 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 ■ pain or cough 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. If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children." ], "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", "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_doctor": [ "Ask a doctor before use if you have ■ liver disease ■ persistent or chronic cough such as occurs with smoking, asthma or emphysema ■ cough that occurs with too much phlegm (mucus)", "Ask a doctor before use if you have ■ liver disease ■ a breathing problem such as emphysema or chronic bronchitis ■ glaucoma ■ trouble urinating due to an enlarged prostate gland ■ persistent or chronic cough such as occurs with smoking, asthma or emphysema ■ cough that occurs with too much phlegm (mucus)" ], "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" ], "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" ], "stop_use": [ "Stop use and ask a doctor if ■ pain or cough 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.", "Stop use and ask a doctor if ■ pain or cough 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." ], "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." ], "keep_out_of_reach_of_children": [ "Keep out of reach of children.", "Keep out of reach of children." ], "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
" ], "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 ​" ], "inactive_ingredient": [ "Inactive ingredients carnauba wax, hypromellose, magnesium stearate, microcrystalline cellulose, powdered cellulose, pregelatinized starch, propylene glycol, sodium starch glycolate, titanium dioxide", "Inactive ingredients carnauba wax, FD&C Blue no.1 aluminum lake, hypromellose, magnesium stearate, microcrystalline cellulose, polydextrose, polyethylene glycol, powdered cellulose, pregelatinized starch, sodium starch glycolate, titanium dioxide, triacetin" ], "questions": [ "Questions or comments? call 1-877-895-3665 (toll-free) or 215-273-8755 (collect)", "Questions or comments? call 1-877-895-3665 (toll-free) or 215-273-8755 (collect)" ], "package_label_principal_display_panel": [ "PRINCIPAL DISPLAY PANEL NDC 50580-551-01 EXTRA STRENGTH TYLENOL ® FOR ADULTS SEVERE COUGH + SORE THROAT NEW! DOSAGE + DIRECTIONS Acetaminophen, Dextromethorphan HBr Pain Reliever-Fever Reducer, Cough Suppressant DAY HEAD + BODY ACHES FEVER + SORE THROAT COUGH Actual Size 16 CAPLETS Acetaminophen, Chlorpheniramine Maleate, Dextromethorphan HBr Pain Reliever-Fever Reducer, Antihistamine, Cough Suppressant NIGHT HEAD + BODY ACHES FEVER + SORE THROAT COUGH RUNNY NOSE Actua Size 8 CAPLETS TOTAL 24 CAPLETS tylenol-1" ], "set_id": "19ad2cca-c1cb-019c-e063-6294a90a5644", "id": "3a190315-8b55-0724-e063-6294a90a7bb5", "effective_time": "20250716", "version": "4", "openfda": { "application_number": [ "M012" ], "brand_name": [ "EXTRA STRENGTH TYLENOL SEVERE COUGH PLUS SORE THROAT DAY/NIGHT" ], "generic_name": [ "ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, CHLORPHENIRAMINE MALEATE" ], "manufacturer_name": [ "Kenvue Brands LLC" ], "product_ndc": [ "50580-551" ], "product_type": [ "HUMAN OTC DRUG" ], "route": [ "ORAL" ], "rxcui": [ "247324", "1098496", "2604579" ], "spl_id": [ "3a190315-8b55-0724-e063-6294a90a7bb5" ], "spl_set_id": [ "19ad2cca-c1cb-019c-e063-6294a90a5644" ], "package_ndc": [ "50580-551-01" ], "is_original_packager": [ true ] } } ] }