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Acetaminophen PM (COSTCO WHOLESALE CORPORATION)

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CAPSULE 375 CAPSULE in 1 BOTTLE, PLASTIC (63981-556-54) Label Information

Complete Acetaminophen PM Information

  • Active ingredients (in each gelcap)

    Acetaminophen 500 mg
    Diphenhydramine HCl 25 mg


  • 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 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 are allergic to acetaminophen or any of the inactive ingredients in this product 

    Ask a doctor before use if you have
    • liver disease
    • glaucoma
    • a breathing problem such as emphysema or chronic bronchitis
    • difficulty in urination due to enlargement of the prostate gland

    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 beverages
    • do not drive a motor vehicle or operate machinery

    Stop use and ask a doctor if
    • new symptoms occur
    • redness or swelling is present
    • sleeplessness persists 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. 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 accidental overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away. Prompt 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
    • 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 

  • Other information

    • use by expiration date on package
    • avoid high humidity
    • store at 25ºC (77ºF); excursions permitted between 15º-30ºC (59º-86ºF)

  • Inactive ingredients

    ammonium hydroxide, colloidal silicon dioxide, croscarmellose sodium, FD&C blue #1, FD&C red #3, gelatin, hydroxypropyl cellulose, hypromellose, iron oxide black, iron oxide red, iron oxide yellow, microcrystalline cellulose, polyethylene glycol, povidone, pregelatinized starch, propylene glycol, shellac glaze, simethicone, stearic acid, titanium dioxide


  • Questions or comments?

    1-800-426-9391
  • Principal Display Panel

    KIRKLAND
    Signatureâ„¢

    COMPARE TO EXTRA STRENGTH TYLENOL® PM
    active ingredients*

    NDC 63981-556-54
    ITM./ART. 596759

    EXTRA STRENGTH
    RAPID RELEASE
    ACETAMINOPHEN PM

    Acetaminophen 500 mg
    Diphenhydramine HCl 25 mg

    Pain Reliever  Nighttime Sleep Aid
    Non-Habit Forming

    Temporarily Relieves:
    Headache
    Minor Aches and
    Pains Accompanied
    by Sleeplessness

    Actual Size
    375
    Rapid Release Gelcaps

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

    Manufactured by: LNK INTERNATIONAL, INC.
    60 Arkay Drive, Hauppauge, NY 11788 USA
    For Costco Wholesale Corporation, P.O. Box 34535
    Seattle, WA 98124-1535 USA    1-800-774-2678
    www.costco.com        17V0218a

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

    50844    REV0615H55654

    This product does not contain gluten.

     

    Kirkland 44-556

    Kirkland 44-556



  • INGREDIENTS AND APPEARANCE
    RAPID RELEASE ACETAMINOPHEN PM  EXTRA STRENGTH
    acetaminophen and diphenhydramine hcl tablet
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:63981-556
    Route of Administration ORAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN 500 mg
    DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M) DIPHENHYDRAMINE HYDROCHLORIDE 25 mg
    Inactive Ingredients
    Ingredient Name Strength
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    FD&C RED NO. 3 (UNII: PN2ZH5LOQY)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    Product Characteristics
    Color BLUE (Dark) , BLUE (Light) Score no score
    Shape OVAL Size 20mm
    Flavor Imprint Code L;6
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:63981-556-54 375 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 12/17/2007
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC MONOGRAPH NOT FINAL part343 12/17/2007
    Labeler - COSTCO WHOLESALE CORPORATION (103391843)
    Establishment
    Name Address ID/FEI Business Operations
    LNK International, Inc. 038154464 PACK(63981-556)
    Establishment
    Name Address ID/FEI Business Operations
    LNK International, Inc. 868734088 MANUFACTURE(63981-556) , PACK(63981-556)
    Establishment
    Name Address ID/FEI Business Operations
    LNK International, Inc. 832867837 PACK(63981-556)
    Establishment
    Name Address ID/FEI Business Operations
    LNK International, Inc. 967626305 PACK(63981-556)