Label: TYLENOL PM EXTRA STRENGTH- acetaminophen and diphenhydramine hydrochloride tablet, film coated

  • NDC Code(s): 50580-608-01, 50580-608-02, 50580-608-03, 50580-608-04, view more
    50580-608-05, 50580-608-06, 50580-608-07, 50580-608-08
  • Packager: Johnson & Johnson Consumer Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated January 22, 2024

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active ingredients (in each caplet)Purpose
    Acetaminophen 500 mgPain reliever
    Diphenhydramine HCl 25 mgNighttime sleep aid
  • Uses

    temporary relief of occasional headaches and minor aches and pains with accompanying sleeplessness

  • 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.
    • with any other product containing diphenhydramine, even one used on skin
    • in children under 12 years of age
    • 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
    • trouble urinating due to an enlarged prostate gland
    • glaucoma

    Ask a doctor or pharmacist before use if you are

    • taking the blood thinning drug warfarin
    • taking sedatives or tranquilizers

    When using this product

    • drowsiness will occur
    • avoid alcoholic drinks
    • do not drive a motor vehicle or operate machinery

    Stop use and ask a doctor if

    • sleeplessness persists continuously for more than 2 weeks. Insomnia may be a symptom of serious underlying medical illness.
    • pain gets worse or lasts more than 10 days
    • fever gets worse or lasts more than 3 days
    • redness or swelling is present
    • new symptoms occur

    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 at bedtime
    • do not take more than 2 caplets of this product in 24 hours
    children under 12 yearsdo not use
  • Other information

    • store between 20-25°C (68-77°F)
    • do not use if carton is opened. Do not use if foil inner seal imprinted with "TYLENOL" is broken or missing
  • Inactive ingredients

    carnauba wax, crospovidone, FD&C blue no. 1 aluminum lake, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, povidone, pregelatinized starch, sodium starch glycolate, stearic acid, titanium dioxide

  • Questions or comments?

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

  • PRINCIPAL DISPLAY PANEL

    NDC 50580-608-03

    Extra Strength
    TYLENOL ®
    PM

    Acetaminophen, Diphenhydramine HCl

    Pain Reliever, Nighttime Sleep Aid
    Non-habit forming

    Actual Size

    150 Caplets

    PRINCIPAL DISPLAY PANEL
  • INGREDIENTS AND APPEARANCE
    TYLENOL PM  EXTRA STRENGTH
    acetaminophen and diphenhydramine hydrochloride tablet, film coated
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50580-608
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN500 mg
    DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M) DIPHENHYDRAMINE HYDROCHLORIDE25 mg
    Inactive Ingredients
    Ingredient NameStrength
    CARNAUBA WAX (UNII: R12CBM0EIZ)  
    CROSPOVIDONE (UNII: 2S7830E561)  
    FD&C BLUE NO. 1 ALUMINUM LAKE (UNII: J9EQA3S2JM)  
    HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)  
    SODIUM STARCH GLYCOLATE TYPE A (UNII: H8AV0SQX4D)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    Colorblue (Light Blue) Scoreno score
    ShapeOVALSize19mm
    FlavorImprint Code TY;PM
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:50580-608-011 in 1 CARTON07/11/2016
    124 in 1 BOTTLE; Type 0: Not a Combination Product
    2NDC:50580-608-021 in 1 CARTON07/11/2016
    2100 in 1 BOTTLE; Type 0: Not a Combination Product
    3NDC:50580-608-031 in 1 CARTON07/11/2016
    3150 in 1 BOTTLE; Type 0: Not a Combination Product
    4NDC:50580-608-041 in 1 CARTON07/11/2016
    4225 in 1 BOTTLE; Type 0: Not a Combination Product
    5NDC:50580-608-052 in 1 POUCH; Type 0: Not a Combination Product07/11/2016
    6NDC:50580-608-0650 in 1 TRAY07/11/2016
    62 in 1 POUCH; Type 0: Not a Combination Product
    7NDC:50580-608-072 in 1 CARTON02/14/2022
    72 in 1 POUCH; Type 0: Not a Combination Product
    8NDC:50580-608-081 in 1 CARTON06/01/2022
    850 in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01307/11/2016
    Labeler - Johnson & Johnson Consumer Inc. (878046358)
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