Label: ACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE tablet, film coated

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

Drug Label Information

Updated January 22, 2024

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  • Drug Facts

    Active ingredients (in each caplet)

    Acetaminophen 500 mg

    Diphenhydramine HCl 25 mg

  • PURPOSE

    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 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 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 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 years: do not use
  • Other information

    store at room temperature

  • 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?

    (800) 231-4670

  • SPL UNCLASSIFIED SECTION

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

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

    DIST BY CAH, DUBLIN, OH 43017

    1-800-200-6313

    © 2018 Cardinal Health

    100% Money Back Guarantee

    Return to place of purchase if not satisfied

  • PRINCIPAL DISPLAY PANEL

    LEADER TM

    NDC 7000-0411-3

    Extra Strength Acetaminophen PM

    Acetaminophen, 500mg

    Diphenhydramine HCl, 25mg

    Pain Reliever/Nighttime Sleep-Aid

    Non-Habit Forming

    COMPARE TO TYLENOL ® PM EXTRA STRENGTH active ingredients*

    100 Caplets

    Cardinal 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 - Cardinal Health (063997360)
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