Label: EXTRA STRENGTH TYLENOL SEVERE COUGH PLUS SORE THROAT NIGHT- acetaminophen, dextromethorphan hydrobromide and doxylamine succinate. liquid

  • NDC Code(s): 50580-243-01
  • Packager: Johnson & Johnson Consumer Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated January 18, 2024

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

  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active ingredients (in each 30 mL)Purpose
    Acetaminophen 1,000 mgPain reliever/fever reducer
    Dextromethorphan HBr 30 mgCough suppressant
    Doxylamine Succinate 12.5 mgAntihistamine
  • 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

    • do not take more than directed (see overdose warning)
    • shake well before using
    • mL = milliliter
    • use only enclosed dosing cup designed for use with this product. Do not use any other dosing device.
    adults and children 12 years and over
    • take 30 mL in the dosing cup provided every 6 hours while symptoms last
    • do not take more than 90 mL 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

    • each 30 mL contains: sodium 19 mg
    • store between 20-25°C (68-77°F)
    • do not use if neck band imprinted with "INSTANT COOLING SENSATION" or foil inner seal imprinted with "TYLENOL" is broken or missing
  • Inactive ingredients

    anhydrous citric acid, carboxymethylcellulose sodium, FD&C blue no. 1, FD&C red no. 40, flavors, glycerin, microcrystalline cellulose and carboxymethylcellulose sodium, poloxamer, polyethylene glycol, propylene glycol, purified water, sodium benzoate, sorbitol, sucralose

  • Questions or comments?

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

  • PRINCIPAL DISPLAY PANEL

    NDC 50580-243-01

    EXTRA STRENGTH TYLENOL ®

    FOR ADULTS

    SEVERE COUGH + SORE THROAT

    NEW!
    DOSAGE + DIRECTIONS

    Acetaminophen,

    1,000 mg / 30 mL

    Dextromethorphan HBr, Doxylamine Succinate
    Pain Reliever–Fever Reducer, Cough Suppressant, Antihistamine

    • HEAD + BODY ACHES
    • FEVER + SORE THROAT
    • COUGH

    NIGHT

    FROSTED BERRY


    8 fl oz (240 mL)

    tylenol-1

  • INGREDIENTS AND APPEARANCE
    EXTRA STRENGTH TYLENOL SEVERE COUGH PLUS SORE THROAT NIGHT 
    acetaminophen, dextromethorphan hydrobromide and doxylamine succinate. liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50580-243
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN1000 mg  in 30 mL
    DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE30 mg  in 30 mL
    DOXYLAMINE SUCCINATE (UNII: V9BI9B5YI2) (DOXYLAMINE - UNII:95QB77JKPL) DOXYLAMINE SUCCINATE12.5 mg  in 30 mL
    Inactive Ingredients
    Ingredient NameStrength
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    SORBITOL (UNII: 506T60A25R)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    Product Characteristics
    ColorpurpleScore    
    ShapeSize
    FlavorBERRYImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:50580-243-01240 mL in 1 BOTTLE; Type 0: Not a Combination Product06/19/2023
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01206/19/2023
    Labeler - Johnson & Johnson Consumer Inc. (878046358)