{"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
"],"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"],"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":["
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
"],"effective_time":"20250717","id":"3a1abd26-c0a9-8a65-e063-6294a90ab66e","inactive_ingredient":["Inactive ingredients carnauba wax, hypromellose, magnesium stearate, microcrystalline cellulose, powdered cellulose, pregelatinized starch, propylene glycol, sodium starch glycolate, titanium dioxide"],"indications_and_usage":["Uses temporarily relieves these common cold/flu symptoms: minor aches and pains headache sore throat cough temporarily reduces fever"],"keep_out_of_reach_of_children":["Keep out of reach of children."],"openfda":{"application_number":["M012"],"brand_name":["EXTRA STRENGTH TYLENOL SEVERE COUGH PLUS SORE THROAT DAY"],"generic_name":["ACETAMINOPHEN AND DEXTROMETHORPHAN HYDROBROMIDE"],"is_original_packager":[true],"manufacturer_name":["Kenvue Brands LLC"],"package_ndc":["50580-446-01"],"product_ndc":["50580-446"],"product_type":["HUMAN OTC DRUG"],"route":["ORAL"],"rxcui":["247324"],"spl_id":["3a1abd26-c0a9-8a65-e063-6294a90ab66e"],"spl_set_id":["1a17b24a-8022-4e2f-e063-6294a90af276"],"substance_name":["DEXTROMETHORPHAN HYDROBROMIDE","ACETAMINOPHEN"],"unii":["9D2RTI9KYH","362O9ITL9D"],"upc":["0300450157348"]},"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"],"pregnancy_or_breast_feeding":["If pregnant or breast-feeding, ask a health professional before use."],"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
"],"questions":["Questions or comments? call 1-877-895-3665 (toll-free) or 215-273-8755 (collect)"],"recent_major_changes":[""],"set_id":"1a17b24a-8022-4e2f-e063-6294a90af276","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"],"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."],"storage_and_handling":["Other information store between 20 - 25°C (68 - 77°F). do not use if blister unit is torn or broken"],"version":"5","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."],"when_using":["When using this product do not exceed recommended dose"]}