Label: TYLENOL EXTRA STRENGTH / TYLENOL PRECISE COOLING PAIN RELIEF- acetaminophen, lidocaine, menthol kit

  • NDC Code(s): 50580-142-01, 50580-490-25, 69968-0793-1
  • Packager: Kenvue Brands LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated November 26, 2024

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  • Drug Facts

    Drug Facts

  • Active ingredient (in each gelcap)

    Acetaminophen 500 mg

  • Purpose

    Pain reliever/fever reducer

  • Uses

    ■ temporarily relieves minor aches and pains due to:

    • headache
    • muscular aches
    • backache
    • minor pain of arthritis
    • the common cold
    • toothache
    • premenstrual and menstrual cramps

    ■ 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.

    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 allergic to acetaminophen or any of the inactive ingredients in this product

    Ask a doctor before use if you have liver disease

    Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin.

    Stop use and ask a doctor if

    ■ pain gets worse or lasts more than 10 days
    ■ fever gets worse or lasts more than 3 days
    ■ new symptoms occur

    ■ redness or swelling is present

    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 gelcaps every 6 hours while symptoms last
    ■ do not take more than 6 gelcaps 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). Avoid high humidity.
    ■ do not use if carton is opened. Do not use if foil inner seal imprinted with “TYLENOL” is broken or missing.​

  • Inactive ingredients

    benzyl alcohol, butylparaben, carboxymethylcellulose sodium, D&C yellow no. 10, edetate calcium disodium, FD&C blue no. 1, FD&C red no. 40, gelatin, hypromellose, iron oxide, magnesium stearate, methylparaben, modified starch, polyethylene glycol, polysorbate 80, powdered cellulose, pregelatinized starch, propylene glycol, propylparaben, red iron oxide, sodium lauryl sulfate, sodium propionate, sodium starch glycolate, titanium dioxide, yellow iron oxide

  • Questions or comments?

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

  • Drug Facts

  • Active Ingredient

    Lidocaine 4%

    Menthol 1%

  • Purpose

    Topical analgesic

    Topical analgesic

  • Uses

    For the temporary relief of pain

  • Warnings

    For external use only.

    Do not use

    ▪ in large quantities, particularly over raw surfaces or blistered areas

    When using this product

    ▪ avoid contact with eyes

    Stop use and ask a doctor if

    ▪ condition worsens or symptoms persist for more than 7 days

    ▪ symptoms clear up and occur again within a few days

    Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

    ■ use only as directed
    ■ adults and children 12 years of age and older: apply to affected area not more than 3 to 4 times daily
    ■ children under 12 years of age: ask a doctor

  • Other Information

    store at 15 ◦ to 30 ◦ C (59 ◦ to 86 ◦ F)

  • Inactive Ingredients

    carbomer copolymer, cetearyl olivate, cetyl alcohol, fragrance, glycerin, isopropyl palmitate, phenoxyethanol, sodium polyacrylate, sorbitan olivate, water

  • Questions?

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

  • PRINCIPAL DISPLAY PANEL

    NDC 50580-142-01

    Extra Strength

    TYLENOL ®


    FOR ADULTS

    Acetaminophen
    Pain Reliever
    Fever Reducer

    RAPID RELEASE GELS


    Actual Size

    225 Gelcaps*
    500 mg each

    *Gelatin-Coated Tablets

    + FREE BONUS ITEM

    TYLENOL ®

    PRECISE TM

    Cooling†

    Pain Relieving Cream

    Lidocaine 4% Menthol 1%

    Fast acting †

    Targeted penetrating

    pain relief

    Maximum Strength Lidocaine

    without a prescription

    LIGHTLY SCENTED

    For external use only

    NET WT. 0.5 OZ (14.2 g)

    tylenol-1

  • INGREDIENTS AND APPEARANCE
    TYLENOL EXTRA STRENGTH / TYLENOL PRECISE COOLING PAIN RELIEF 
    acetaminophen, lidocaine, menthol kit
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50580-142
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:50580-142-011 in 1 KIT; Type 1: Convenience Kit of Co-Package11/25/2024
    Quantity of Parts
    Part #Package QuantityTotal Product Quantity
    Part 11 BOTTLE 225 
    Part 21 TUBE 14.2 g
    Part 1 of 2
    TYLENOL EXTRA STRENGTH 
    acetaminophen tablet, coated
    Product Information
    Item Code (Source)NDC:50580-490
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN500 mg
    Inactive Ingredients
    Ingredient NameStrength
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED (UNII: K679OBS311)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    POWDERED CELLULOSE (UNII: SMD1X3XO9M)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    BUTYLPARABEN (UNII: 3QPI1U3FV8)  
    GELATIN, UNSPECIFIED (UNII: 2G86QN327L)  
    EDETATE CALCIUM DISODIUM (UNII: 25IH6R4SGF)  
    HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    SODIUM PROPIONATE (UNII: DK6Y9P42IN)  
    SODIUM STARCH GLYCOLATE TYPE A (UNII: H8AV0SQX4D)  
    Product Characteristics
    Colorblue, red, grayScoreno score
    ShapeOVALSize21mm
    FlavorImprint Code TY;500
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:50580-490-251 in 1 CARTON
    1225 in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01304/30/2021
    Part 2 of 2
    TYLENOL PRECISE COOLING PAIN RELIEVING 
    lidocaine, menthol cream
    Product Information
    Item Code (Source)NDC:69968-0793
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987) LIDOCAINE40 mg  in 1 g
    MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL, UNSPECIFIED FORM10 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    SORBITAN OLIVATE (UNII: MDL271E3GR)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    CETEARYL OLIVATE (UNII: 58B69Q84JO)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM POLYACRYLATE (2500000 MW) (UNII: 05I15JNI2J)  
    ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69968-0793-11 in 1 CARTON
    114.2 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01711/25/2024
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01311/25/2024
    Labeler - Kenvue Brands LLC (118772437)
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