Label: EXTRA STRENGTH TYLENOL SEVERE COUGH PLUS SORE THROAT DAY- acetaminophen and dextromethorphan hydrobromide tablet, film coated
- NDC Code(s): 50580-446-01
- Packager: Kenvue Brands LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated July 17, 2025
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- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- ACTIVE INGREDIENT
- Uses
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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)
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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 - Other information
- Inactive ingredients
- Questions or comments?
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
EXTRA STRENGTH TYLENOL SEVERE COUGH PLUS SORE THROAT DAY
acetaminophen and dextromethorphan hydrobromide tablet, film coatedProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:50580-446 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE 15 mg ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN 500 mg Inactive Ingredients Ingredient Name Strength MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U) MAGNESIUM STEARATE (UNII: 70097M6I30) POWDERED CELLULOSE (UNII: SMD1X3XO9M) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) SODIUM STARCH GLYCOLATE TYPE A (UNII: H8AV0SQX4D) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) CARNAUBA WAX (UNII: R12CBM0EIZ) HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO) Product Characteristics Color white Score no score Shape OVAL Size 18mm Flavor Imprint Code TYCOLD;1409 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:50580-446-01 2 in 1 CARTON 08/26/2024 1 12 in 1 BLISTER PACK; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M012 08/26/2024 Labeler - Kenvue Brands LLC (118772437)
