Label: PAIN RELIEVER PM- acetaminophen and diphenhydramine citrate tablet 

  • Label RSS
  • 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 09/13

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

  • Active ingredients (in each tablet)

    Acetaminophen 500 mg
    Diphenhydramine citrate 38 mg

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  • Purpose

    Pain reliever
    Nighttime sleep-aid

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  • Uses

    for the 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 containin diphenhydramine, even one used on skin

    • in children under 12 years of age

    Ask a doctor before use if

    • a breathing problem such as emphysema or chronic bronchitis

    • liver disease

    • trouble urinating due to an enlarged prostate gland

    • glaucoma

    Ask a doctor or pharmacist before use if

    • taking sedatives or tranquilizers

    • taking the blood thinning drug warfarin

    When using this product

    • drowsiness may occur

    • avoid alcoholic beverages

    • be careful when driving a motor vehicle or operating machinery

    Stop use and ask a doctor if

    • sleeplessness lasts continuously for more than 2 weeks. Insomnia may be a symptom of a serious underlying medical illness.

    • pain gets worse or lasts more than 10 days

    • fever gets worse or lasts more than 3 days

    • new symptoms occur

    • painful area is red or swollen

    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: 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. 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 overdose warning)

    • adults and children 12 years and over: take 2 tablets at bedtime. Do not take more than 2 tablets 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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  • Other information

    • store at 25ºC (77ºF); excursions permitted between 15°-30°C (59°-86°F)

    • see end flap for expiration date and lot number

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  • Inactive ingredients

    corn starch, croscarmellose sodium, crospovidone, FD&C blue #1 aluminum lake, FD&C blue #2 aluminum lake, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, povidone, shellac, silica gel, stearic acid, titanium dioxide

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  • Questions or comments?

    1-800-426-9391

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  • Principal Display Panel

    NDC 21130-373-15
    Compare to Excedrin® PM Tablets active ingredients*

    Aspirin Free
    Pain Reliever PM
    Acetaminophen 500 mg,
    Diphenhydramine citrate 38 mg
    • Pain Reliever • Nighttime Sleep-Aid
    • Non-Habit Forming

    50 COATED TABLETS

    SAFEWAY®

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

    *This product is not manufactured or distributed by Novartis Consumer Health, Inc., distributors of Excedrin® PM.
    50844    REV0712B37315

    DISTRIBUTED BY SAFEWAY INC.
    P.O. BOX 99, PLEASANTON, CA 94566-0009
    QUALITY & SATISFACTION GUARANTEED
    OR YOUR MONEY BACK
    1-888-SAFEWAY / www.safeway.com

    Safeway 44-373

    Safeway 44-373

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  • INGREDIENTS AND APPEARANCE
    PAIN RELIEVER PM 
    acetaminophen and diphenhydramine citrate tablet
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:21130-373
    Route of Administration ORAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN 500 mg
    DIPHENHYDRAMINE CITRATE (DIPHENHYDRAMINE) DIPHENHYDRAMINE CITRATE 38 mg
    Inactive Ingredients
    Ingredient Name Strength
    CROSCARMELLOSE SODIUM  
    CROSPOVIDONE  
    FD&C BLUE NO. 1  
    FD&C BLUE NO. 2  
    HYPROMELLOSES  
    MAGNESIUM STEARATE  
    CELLULOSE, MICROCRYSTALLINE  
    POLYETHYLENE GLYCOLS  
    POLYSORBATE 80  
    POVIDONES  
    STEARIC ACID  
    TITANIUM DIOXIDE  
    Product Characteristics
    Color BLUE Score no score
    Shape ROUND Size 11mm
    Flavor Imprint Code 44;373
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:21130-373-15 1 in 1 CARTON
    1 50 in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC MONOGRAPH FINAL part341 06/07/2004
    Labeler - Safeway (009137209)
    Establishment
    Name Address ID/FEI Business Operations
    LNK International, Inc. 832867894 MANUFACTURE(21130-373)
    Establishment
    Name Address ID/FEI Business Operations
    LNK International, Inc. 038154464 PACK(21130-373)
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