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

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated July 29, 2019

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  • Drug Facts

  • Active ingredients (in each caplet)

    Acetaminophen 500 mg

    Diphenhydramine HCl 25 mg

    Purpose

    Pain reliever

    Nighttime 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

    ■ do not take more than directed (see overdose warning)

    adults and children ■ take 2 caplets at bedtime

    12 years and over ■ do not take more than 2 caplets of

    this product in 24 hours

    children under 12 years do not use

  • Other information

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

  • 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)

  • Package Labeling

    Package Label

  • INGREDIENTS AND APPEARANCE
    TYLENOL PM 
    acetaminophen, diphenhydramine hydrochloride tablet, film coated
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:73097-013(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
    SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
    CARNAUBA WAX (UNII: R12CBM0EIZ)  
    CROSPOVIDONE (UNII: 2S7830E561)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    POVIDONE (UNII: FZ989GH94E)  
    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:73097-013-021 in 1 CARTON07/22/2019
    12 in 1 POUCH; Type 0: Not a Combination Product
    2NDC:73097-013-4020 in 1 CARTON07/22/2019
    22 in 1 POUCH; Type 0: Not a Combination Product
    3NDC:73097-013-5025 in 1 CARTON07/22/2019
    32 in 1 POUCH; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34307/22/2019
    Labeler - Savings Distributors LLC (010527359)
    Establishment
    NameAddressID/FEIBusiness Operations
    Savings Distributors LLC010527359repack(73097-013)
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