{ "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": 8 } }, "results": [ { "spl_product_data_elements": [ "EXTRA STRENGTH TYLENOL SEVERE COUGH PLUS SORE THROAT DAY Acetaminophen and Dextromethorphan Hydrobromide MICROCRYSTALLINE CELLULOSE MAGNESIUM STEARATE POWDERED CELLULOSE PROPYLENE GLYCOL SODIUM STARCH GLYCOLATE TYPE A TITANIUM DIOXIDE DEXTROMETHORPHAN HYDROBROMIDE DEXTROMETHORPHAN CARNAUBA WAX HYPROMELLOSE, UNSPECIFIED ACETAMINOPHEN ACETAMINOPHEN TYCOLD;1409" ], "spl_unclassified_section": [ "Drug Facts" ], "active_ingredient": [ "Active ingredients (in each caplet) Purpose Acetaminophen 500 mg Pain reliever/fever reducer 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
" ], "purpose": [ "Active ingredients (in each caplet) Purpose Acetaminophen 500 mg Pain reliever/fever reducer 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
" ], "indications_and_usage": [ "Uses temporarily relieves these common cold/flu symptoms: minor aches and pains headache sore throat cough 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." ], "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" ], "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_doctor_or_pharmacist": [ "Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin" ], "when_using": [ "When using this product do not exceed recommended dose" ], "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." ], "pregnancy_or_breast_feeding": [ "If pregnant or breast-feeding, ask a health professional before use." ], "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" ], "dosage_and_administration_table": [ "
adults and children 12 years and overtake 2 caplets every 6 hours while symptoms lastdo not take more than 6 caplets in 24 hours, unless directed by a doctordo 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" ], "inactive_ingredient": [ "Inactive ingredients carnauba wax, hypromellose, magnesium stearate, microcrystalline cellulose, powdered cellulose, pregelatinized starch, propylene glycol, sodium starch glycolate, titanium dioxide" ], "questions": [ "Questions or comments? call 1-877-895-3665 (toll-free) or 215-273-8755 (collect)" ], "recent_major_changes": [ "" ], "package_label_principal_display_panel": [ "PRINCIPAL DISPLAY PANEL NDC 50580-446-01 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 24 CAPLETS tylenol-1" ], "set_id": "1a17b24a-8022-4e2f-e063-6294a90af276", "id": "3a1abd26-c0a9-8a65-e063-6294a90ab66e", "effective_time": "20250717", "version": "5", "openfda": { "application_number": [ "M012" ], "brand_name": [ "EXTRA STRENGTH TYLENOL SEVERE COUGH PLUS SORE THROAT DAY" ], "generic_name": [ "ACETAMINOPHEN AND DEXTROMETHORPHAN HYDROBROMIDE" ], "manufacturer_name": [ "Kenvue Brands LLC" ], "product_ndc": [ "50580-446" ], "product_type": [ "HUMAN OTC DRUG" ], "route": [ "ORAL" ], "substance_name": [ "ACETAMINOPHEN", "DEXTROMETHORPHAN HYDROBROMIDE" ], "rxcui": [ "247324" ], "spl_id": [ "3a1abd26-c0a9-8a65-e063-6294a90ab66e" ], "spl_set_id": [ "1a17b24a-8022-4e2f-e063-6294a90af276" ], "package_ndc": [ "50580-446-01" ], "is_original_packager": [ true ], "upc": [ "0300450157348" ], "unii": [ "362O9ITL9D", "9D2RTI9KYH" ] } } ] }