Label: EXTRA STRENGTH TYLENOL SEVERE COUGH PLUS SORE THROAT DAY/NIGHT- acetaminophen, dextromethorphan hydrobromide, chlorpheniramine maleate kit
- NDC Code(s): 50580-551-01
- Packager: Kenvue Brands LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated July 16, 2025
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- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- ACTIVE INGREDIENT
- Uses
-
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 productAllergy 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 ingredientsAsk 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) -
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 doctorchildren under 12 years ask a doctor - Other information
- Inactive ingredients
- Questions or comments?
- SPL UNCLASSIFIED SECTION
- ACTIVE INGREDIENT
- Uses
-
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 productAllergy 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 ingredientsAsk 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
- Overdose warning
-
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 doctorchildren under 12 years ask a doctor - Other information
- Inactive ingredients
- Questions or comments?
-
PRINCIPAL DISPLAY PANEL
NDC 50580-551-01
EXTRA STRENGTH
TYLENOL ®
FOR ADULTSSEVERE COUGH + SORE THROAT
NEW!
DOSAGE + DIRECTIONS
Acetaminophen, Dextromethorphan HBr
Pain Reliever-Fever Reducer, Cough SuppressantDAY
- 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

-
INGREDIENTS AND APPEARANCE
EXTRA STRENGTH TYLENOL SEVERE COUGH PLUS SORE THROAT DAY/NIGHT
acetaminophen, dextromethorphan hydrobromide, chlorpheniramine maleate kitProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:50580-551 Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:50580-551-01 1 in 1 PACKAGE; Type 1: Convenience Kit of Co-Package 08/26/2024 Quantity of Parts Part # Package Quantity Total Product Quantity Part 1 2 BLISTER PACK 16 Part 2 2 BLISTER PACK 8 Part 1 of 2 TYLENOL
acetaminophen and dextromethorphan hydrobromide tablet, film coatedProduct Information Item Code (Source) NDC:65498-446 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN 500 mg DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE 15 mg Inactive Ingredients Ingredient Name Strength PROPYLENE GLYCOL (UNII: 6DC9Q167V3) POWDERED CELLULOSE (UNII: SMD1X3XO9M) SODIUM STARCH GLYCOLATE TYPE A (UNII: H8AV0SQX4D) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) CARNAUBA WAX (UNII: R12CBM0EIZ) HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO) MAGNESIUM STEARATE (UNII: 70097M6I30) MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U) Product Characteristics Color white Score no score Shape OVAL Size 18mm Flavor Imprint Code TY;COLD;1409 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 2 in 1 KIT 1 8 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 Part 2 of 2 TYLENOL
acetaminophen, dextromethorphan hydrobromide, and chlorpheniramine maleate tablet, film coatedProduct Information Item Code (Source) NDC:65498-551 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN 500 mg DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE 15 mg CHLORPHENIRAMINE MALEATE (UNII: V1Q0O9OJ9Z) (CHLORPHENIRAMINE - UNII:3U6IO1965U) CHLORPHENIRAMINE MALEATE 2 mg Inactive Ingredients Ingredient Name Strength POWDERED CELLULOSE (UNII: SMD1X3XO9M) TRIACETIN (UNII: XHX3C3X673) FD&C BLUE NO. 1 ALUMINUM LAKE (UNII: J9EQA3S2JM) POLYDEXTROSE (UNII: VH2XOU12IE) HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO) MAGNESIUM STEARATE (UNII: 70097M6I30) MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U) POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) CARNAUBA WAX (UNII: R12CBM0EIZ) SODIUM STARCH GLYCOLATE TYPE A (UNII: H8AV0SQX4D) Product Characteristics Color blue Score no score Shape OVAL Size 18mm Flavor Imprint Code TY;COLD;1410 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 2 in 1 KIT 1 4 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 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)
