Label: PAIN RELIEVER PM EXTRA STRENGTH- acetaminophen and diphenhydramine hydrochloride tablet 

  • NDC Code(s): 49348-918-09, 49348-918-10
  • Packager: Mckesson (Sunmark)
  • 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 09/12

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

  • Active ingredients (in each caplet)

    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 accompanying sleeplessness

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  • Warnings

    Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take:

    • more than 2 caplets in 24 hours, which is maximum daily amount 
    • 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 other products 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

    If pregnant or breast-feeding,

    ask a health care professional before use.

    Keep out of reach of children.

    Overdose warning: Taking more than the recommended dose (overdose) may cause liver damage. 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 this adult product in children under 12 years of age; this will provide more than the recommended dose (overdose) and may cause liver damage

    Other information

    • store at room temperature 15o- 30o C (59o- 86o F), avoid high humidity and excessive heat
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  • Inactive ingredients

    colloidal silicon dioxide*, croscarmellose sodium*, D&C Yellow #10 Aluminum Lake*, FD&C Blue #1 Aluminum Lake, FD&C Blue #2 Aluminum Lake, hypromellose, magnesium silicate*, magnesium stearate*, microcrystalline cellulose, mineral oil*, polyethylene glycol, polyvinyl alcohol*, povidone, pregelatinized starch, silica*, sodium starch glycolate*, stearic acid, talc*, titanium dioxide, triacetin*, and yellow iron oxide*

    *contains one or more of these ingredients

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  • Questions or comments?

    Call toll free 1-877-753-3935 Monday- Friday 9AM- 5PM EST

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  • Principal Display Panel

    Compare to TYLENOL® PM active ingredients**

    Pain Reliever PM

    extra strength

    sleep aid for pain with sleeplessness

    ACETAMINOPHEN 500 mg

    DIPHENHYDRAMINE HCl 25 mg

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

    KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION

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

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  • Product Label

    Sunmark Pain relief PM

    Pain reliever PM

     

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  • INGREDIENTS AND APPEARANCE
    PAIN RELIEVER PM  EXTRA STRENGTH
    acetaminophen, diphenhydramine hcl tablet
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:49348-918
    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 YELLOW NO. 10  
    FD&C BLUE NO. 1  
    FD&C BLUE NO. 2  
    HYPROMELLOSES  
    MAGNESIUM SILICATE  
    MAGNESIUM STEARATE  
    CELLULOSE, MICROCRYSTALLINE  
    MINERAL OIL  
    POLYETHYLENE GLYCOLS  
    POLYVINYL ALCOHOL  
    POVIDONES  
    STARCH, CORN  
    SILICON DIOXIDE  
    SODIUM STARCH GLYCOLATE TYPE A CORN  
    STEARIC ACID  
    TITANIUM DIOXIDE  
    TRIACETIN  
    FERRIC OXIDE YELLOW  
    TALC  
    Product Characteristics
    Color BLUE (Light blue) Score no score
    Shape CAPSULE Size 18mm
    Flavor Imprint Code S525;V15;AV;CPC752
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:49348-918-10 1 in 1 CARTON
    1 100 in 1 BOTTLE
    2 NDC:49348-918-09 1 in 1 CARTON
    2 50 in 1 BOTTLE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC MONOGRAPH FINAL part338 05/24/2011
    Labeler - Mckesson (Sunmark) (177667227)
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