Label: ACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE tablet, film coated

  • NDC Code(s): 70000-0411-1, 70000-0411-2, 70000-0411-3
  • Packager: LEADER/ Cardinal Health 110, Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated February 26, 2026

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  • Drug Facts

    Active ingredients (in each caplet)

    Acetaminophen 500 mg

    Diphenhydramine HCl 25 mg

  • PURPOSE

    Purposes

    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 product containing diphenhydramine, even one used on skin
    • in children under 12 years of age
    • 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 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

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

    Stop use and ask a doctor if

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

    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 (1-800-222-1222) right away. 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 12 years of age and over: take 2 caplets at bedtime. Do not take more than 2 caplets of this product in 24 hours.
    • children under 12 years: do not use
  • Other information

    • store in a dry place at 15°-30°C (59°-86°F).
    • see end flap for expiration date and lot number.
  • INACTIVE INGREDIENT

    croscarmellose sodium, D&C yellow #10 aluminum lake, FD&C blue #1 aluminum lake, hypromellose, magnesium stearate, mineral oil, polyvinylpyrrolidone, pregelatinized starch, silica, sodium starch glycolate, stearic acid, talc, titanium dioxide, triacetin

  • Questions or comments?

    1-800-231-4670

  • SPL UNCLASSIFIED SECTION

    *This product is not manufactured or distributed by Kenvue Inc., owner of the registered trademark Tylenol® PM Extra Strength.

    TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

    DISTRIBUTED BY CARDINAL HEALTH

    DUBLIN, OHIO 43017

    www.myleader.com 1-800-200-6313

    © 2025 Cardinal Health. All Rights Reserved. CARDINAL HEALTH, the Cardinal Health LOGO, ESSENTIAL TO CARE, LEADER, and the LEADER LOGO are trademarks or registered trademarks of Cardinal Health. All other marks are the property of their respective owners.

    100% Money Back Guarantee

    Return to place of purchase if not satisfied

  • PRINCIPAL DISPLAY PANEL

    LEADER TM

    NDC 70000-0411-3

    Extra Strength Acetaminophen PM

    Acetaminophen, 500 mg

    Diphenhydramine HCl, 25 mg

    Pain Reliever/Nighttime Sleep-Aid

    COMPARE TO TYLENOL ® PM EXTRA STRENGTH active ingredients*

    100 CAPLETS

    Leader label

  • INGREDIENTS AND APPEARANCE
    ACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE 
    acetaminophen, diphenhydramine hydrochloride tablet, film coated
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70000-0411
    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
    TALC (UNII: 7SEV7J4R1U)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    LIGHT MINERAL OIL (UNII: N6K5787QVP)  
    D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    TRIACETIN (UNII: XHX3C3X673)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    POVIDONE K30 (UNII: U725QWY32X)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
    Product Characteristics
    ColorblueScoreno score
    ShapeOVALSize17mm
    FlavorImprint Code CPC752
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70000-0411-250 in 1 BOTTLE; Type 0: Not a Combination Product11/29/2018
    2NDC:70000-0411-11 in 1 CARTON12/10/2018
    224 in 1 BOTTLE; Type 0: Not a Combination Product
    3NDC:70000-0411-31 in 1 CARTON12/10/2018
    3100 in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01311/29/2018
    Labeler - LEADER/ Cardinal Health 110, Inc. (063997360)
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