Label: EXTRA STRENGTH TYLENOL SEVERE COUGH PLUS SORE THROAT DAY/NIGHT- acetaminophen, dextromethorphan hydrobromide, chlorpheniramine maleate kit

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated July 16, 2025

If you are a consumer or patient please visit this version.

  • SPL UNCLASSIFIED SECTION

    EXTRA STRENGTH TYLENOL® SEVERE COUGH + SORE THROAT DAY

    Drug Facts

  • ACTIVE INGREDIENT

    Active ingredients (in each caplet)Purpose
    Acetaminophen 500 mgPain reliever/fever reducer
    Dextromethorphan HBr 15 mgCough suppressant
  • Uses

    ■ temporarily relieves these common cold/flu symptoms:

    ■ minor aches and pains

    ■ headache

    ■ sore throat

    ■ cough

    ■ temporarily reduces fever

  • 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.

  • Directions

    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
  • Other information

    ■ store between 20 - 25°C (68 - 77°F)
    do not use if blister unit is torn or broken

  • Inactive ingredients

    carnauba wax, hypromellose, magnesium stearate, microcrystalline cellulose, powdered cellulose, pregelatinized starch, propylene glycol, sodium starch glycolate, titanium dioxide

  • Questions or comments?

    call 1-877-895-3665 (toll-free) or 215-273-8755 (collect)

  • SPL UNCLASSIFIED SECTION

    EXTRA STRENGTH TYLENOL® SEVERE COUGH + SORE THROAT NIGHT

    Drug Facts

  • ACTIVE INGREDIENT

    Active ingredients (in each caplet)

    Purpose

    Acetaminophen 500 mg

    Pain reliever/fever reducer
    Chlorpheniramine maleate 2 mgAntihistamine
    Dextromethorphan HBr 15 mgCough suppressant

  • Uses

    ■ temporarily relieves these common cold/flu symptoms:

    ■ minor aches and pains

    ■ headache

    ■ sore throat

    ■ cough

    ■ sneezing and runny nose

    ■ temporarily reduces fever

  • 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.

  • 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.

  • Directions

    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
  • Other information

    ■ store between 20 - 25°C (68 - 77°F)
    ■ do not use if blister unit is torn or broken

  • 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 or comments?

    call 1-877-895-3665 (toll-free) or 215-273-8755 (collect)

  • 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

  • INGREDIENTS AND APPEARANCE
    EXTRA STRENGTH TYLENOL SEVERE COUGH PLUS SORE THROAT DAY/NIGHT 
    acetaminophen, dextromethorphan hydrobromide, chlorpheniramine maleate kit
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50580-551
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:50580-551-011 in 1 PACKAGE; Type 1: Convenience Kit of Co-Package08/26/2024
    Quantity of Parts
    Part #Package QuantityTotal Product Quantity
    Part 12 BLISTER PACK 16 
    Part 22 BLISTER PACK
    Part 1 of 2
    TYLENOL 
    acetaminophen and dextromethorphan hydrobromide tablet, film coated
    Product Information
    Item Code (Source)NDC:65498-446
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN500 mg
    DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE15 mg
    Inactive Ingredients
    Ingredient NameStrength
    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
    ColorwhiteScoreno score
    ShapeOVALSize18mm
    FlavorImprint Code TY;COLD;1409
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    12 in 1 KIT
    18 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01208/26/2024
    Part 2 of 2
    TYLENOL 
    acetaminophen, dextromethorphan hydrobromide, and chlorpheniramine maleate tablet, film coated
    Product Information
    Item Code (Source)NDC:65498-551
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN500 mg
    DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE15 mg
    CHLORPHENIRAMINE MALEATE (UNII: V1Q0O9OJ9Z) (CHLORPHENIRAMINE - UNII:3U6IO1965U) CHLORPHENIRAMINE MALEATE2 mg
    Inactive Ingredients
    Ingredient NameStrength
    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
    ColorblueScoreno score
    ShapeOVALSize18mm
    FlavorImprint Code TY;COLD;1410
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    12 in 1 KIT
    14 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01208/26/2024
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01208/26/2024
    Labeler - Kenvue Brands LLC (118772437)