Label: ACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDE tablet

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated July 2, 2025

If you are a consumer or patient please visit this version.

  • 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 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 (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 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 between 20-25°C (68-77°F)
    • DO NOT USE IF PRINTED SEAL UNDER CAP IS MISSING OR DAMAGED
  • Inactive ingredients

    brilliant blue lake, colloidal silicon dioxide, indigo carmine lake, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, pregelatinized starch, PVP-K30, sodium starch glycolate, stearic acid, talc, titanium dioxide.

  • Questions?

    call toll free 1-844-912-4012

  • PRINCIPAL DISPLAY PANEL-100 Count

    NDC 37835-537-01

    Compare to the active ingredients in Extra Strength Tylenol ®PM*

    EXTRA STRENGTH PAIN RELIEVER PM

    Acetaminophen, Diphenhydramine HCl

    Pain Reliever / Nighttime Sleep Aid

    100 Caplets

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

    Distributed by:

    BI-MART

    Eugene, OR 97402

    label

  • PRINCIPAL DISPLAY PANEL-250 Count

    NDC 37835-537-25

    Compare to the active ingredients in Extra Strength Tylenol ®PM*

    EXTRA STRENGTH PAIN RELIEVER PM

    Acetaminophen, Diphenhydramine HCl

    Pain Reliever / Nighttime Sleep Aid

    250 Caplets

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

    Distributed by:

    BI-MART

    Eugene, OR 97402

    label

  • INGREDIENTS AND APPEARANCE
    ACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDE 
    acetaminophen and diphenhydramine hydrochloride tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:37835-537
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN500 mg
    DIPHENHYDRAMINE (UNII: 8GTS82S83M) (DIPHENHYDRAMINE - UNII:8GTS82S83M) DIPHENHYDRAMINE25 mg
    Inactive Ingredients
    Ingredient NameStrength
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    POLYVINYL ALCOHOL (UNII: 532B59J990)  
    STARCH, PREGELATINIZED CORN (UNII: O8232NY3SJ)  
    POVIDONE K30 (UNII: U725QWY32X)  
    SODIUM STARCH GLYCOLATE TYPE A CORN (UNII: AG9B65PV6B)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    TALC (UNII: 7SEV7J4R1U)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    ColorblueScoreno score
    ShapeOVALSize17mm
    FlavorImprint Code APM
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:37835-537-01100 in 1 BOTTLE; Type 0: Not a Combination Product02/01/2025
    2NDC:37835-537-25250 in 1 BOTTLE; Type 0: Not a Combination Product02/01/2025
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01302/01/2025
    Labeler - Bi-Mart (027630078)
    Establishment
    NameAddressID/FEIBusiness Operations
    ELYSIUM PHARMACEUTICALS LIMITED915664486manufacture(37835-537)