PAIN RELIEF PM EXTRA STRENGTH (ACETAMINOPHEN, DIPHENHYDRAMINE HCL) TABLET, COATED [EQUATE (WALMART STORES, INC.)]

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  • PAIN RELIEF PM EXTRA STRENGTH (ACETAMINOPHEN, DIPHENHYDRAMINE HCL) TABLET, COATED [EQUATE (WALMART STORES, INC.)]

PAIN RELIEF PM EXTRA STRENGTH (ACETAMINOPHEN, DIPHENHYDRAMINE HCL) TABLET, COATED [EQUATE (WALMART STORES, INC.)]
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NDC 49035-223-01, 49035-223-25
Set ID 859eb682-f8dd-4907-86f9-616cfbb6747f
Category HUMAN OTC DRUG LABEL
Packager EQUATE (Wal-Mart Stores, Inc.)
Generic Name
Product Class
Product Number
Application Number PART341
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  • Active ingredients (in each caplet)

    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

    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

    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 a serious underlying medical illness.
    • new symptoms occur
    • redness or swelling is present
    • 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.

    Overdose warning: 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.

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

    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*, povidone, pregelatinized starch, silica*, sodium starch glycolate*, stearic acid, titanium dioxide, triacetin*

    *contains one or more of these ingredients

  • Questions or comments?

    Call 1-888-287-915

  • Principal Display Panel

    Compare to Extra Strength Tylenol® PM Active Ingredients†

    Extra Strength

    Acetaminophen PM

    Acetaminophen 500 mg, Diphenhydramine HCl 25 mg

    Pain Reliever/Nighttime Sleep Aid

    Non-Habit Forming

    Caplets

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

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

    Distributed by: Wal-Mart Stores, Inc., Bentonville, AR 72716     

  • Package Label

    Acetaminophen 500 mg, Diphenhydramine HCl 25 mg

    Equate Extra Strength Acetaminophen PM Tablets

     
  • INGREDIENTS AND APPEARANCE
    PAIN RELIEF PM  EXTRA STRENGTH
    acetaminophen, diphenhydramine hcl tablet, coated
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49035-223
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN500 mg
    DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M) DIPHENHYDRAMINE HYDROCHLORIDE25 mg
    Inactive Ingredients
    Ingredient NameStrength
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    FD&C BLUE NO. 2 (UNII: L06K8R7DQK)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    POVIDONE (UNII: FZ989GH94E)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
    MAGNESIUM SILICATE (UNII: 9B9691B2N9)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    SODIUM STARCH GLYCOLATE TYPE A CORN (UNII: AG9B65PV6B)  
    TRIACETIN (UNII: XHX3C3X673)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    Product Characteristics
    ColorBLUEScoreno score
    ShapeCAPSULESize18mm
    FlavorImprint Code S525;CPC752
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:49035-223-01100 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product06/30/201412/30/2021
    2NDC:49035-223-25225 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product06/30/201412/30/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart34106/30/201412/30/2021
    Labeler - EQUATE (Wal-Mart Stores, Inc.) (051957769)
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