Label: PAIN RELIEF PM EXTRA STRENGTH- acetaminophen and diphenhydramine hydrochloride capsule, coated

  • NDC Code(s): 42507-829-27, 42507-829-49, 42507-829-60
  • Packager: HyVee Inc
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

NOTE: Most over the counter (OTC) are not reviewed and approved by the 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 02/13

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

  • Active ingredient (in each gelcap)

    Acetaminophen 500 mg

    Diphenhydramine HCl 25 mg

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  • Purpose

    Pain reliever

    Nighttime sleep-aid

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  • Uses

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

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  • 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

    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.

    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.

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  • Directions

    do not take more than directed (see Liver warning)

    adults and children 12 years and over

    take 2 gelcaps at bedtime
    do not take more than 2 gelcaps of this product in 24 hours

    children under 12 years

    do not use this adult product in children under 12 years of age; this will provide more than the recommended dose (overdose) and may cause liver damage

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  • Inactive ingredients

    colloidal silicon dioxide, croscarmellose sodium, D&C red #28, D&C yellow #10, edible ink, FD&C blue #1, FD&C blue #2 aluminum lake, FD&C red #40, FD&C red #40 aluminum lake, FD&C yellow #6 aluminum lake, gelatin, hydroxypropyl cellulose, hypromellose, microcrystalline cellulose, povidone, pregelatinized starch, stearic acid, titanium dioxide, triacetin

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  • Questions?

    1-800-719-9260

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  • Package/Label Principal Display Panel

    Compare to Extra Strength Tylenol® PM active ingredients

    PAIN RELIEF PM

    EXTRA STRENGTH

    Pain Reliever

    Night Time Sleep-Aid

    Acetaminophen/Diphenhydramine HCl

    Actual Size

    Rapid Release

    Pain Relief PM Carton Image 1
    Pain Relief PM Carton Image 2
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  • INGREDIENTS AND APPEARANCE
    PAIN RELIEF PM  EXTRA STRENGTH
    acetaminophen, diphenhydramine hcl capsule, coated
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:42507-829
    Route of Administration ORAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN 500 mg
    DIPHENHYDRAMINE HYDROCHLORIDE (DIPHENHYDRAMINE) DIPHENHYDRAMINE HYDROCHLORIDE 25 mg
    Inactive Ingredients
    Ingredient Name Strength
    SILICON DIOXIDE  
    CROSCARMELLOSE SODIUM  
    D&C RED NO. 28  
    D&C YELLOW NO. 10  
    FD&C BLUE NO. 1  
    FD&C BLUE NO. 2  
    FD&C YELLOW NO. 6  
    FD&C RED NO. 40  
    GELATIN  
    HYDROXYPROPYL CELLULOSE (TYPE H)  
    HYPROMELLOSES  
    CELLULOSE, MICROCRYSTALLINE  
    POVIDONES  
    STEARIC ACID  
    TITANIUM DIOXIDE  
    TRIACETIN  
    Product Characteristics
    Color BLUE (Dark Blue Opaque) , GRAY, BLUE (Light Blue Opaque) Score no score
    Shape CAPSULE Size 22mm
    Flavor Imprint Code L829
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:42507-829-27 1 in 1 CARTON
    1 80 in 1 BOTTLE
    2 NDC:42507-829-49 1 in 1 CARTON
    2 40 in 1 BOTTLE
    3 NDC:42507-829-60 1 in 1 CARTON
    3 20 in 1 BOTTLE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part338 08/02/2010
    Labeler - HyVee Inc (006925671)
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