PAIN RELIEVER PM EXTRA STRENGTH (ACETAMINOPHEN, DIPHENHYDRAMINE HCL) CAPSULE [FAMILY DOLLAR (FAMILY WELLNESS)]

PAIN RELIEVER PM EXTRA STRENGTH (ACETAMINOPHEN, DIPHENHYDRAMINE HCL) CAPSULE [FAMILY DOLLAR (FAMILY WELLNESS)]
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NDC 55319-237-03, 55319-237-12
Set ID 7b44e456-e9da-46ac-a805-0ffc0cab5992
Category HUMAN OTC DRUG LABEL
Packager Family Dollar (FAMILY WELLNESS)
Generic Name
Product Class
Product Number
Application Number PART341
  • 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

    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 

    Stop use and ask a doctor if

    • sleeplessness persists continuosuly 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 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

    • store between 20o- 25o C (68o- 77o F)
    • avoid high humidity
  • Inactive ingredients

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

  • Questions or comments?

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

  • Principal Display Panel

    Compare to the active ingredients of TYLENOL® PM*

    Extra Strength

    Pain Reliever PM

    Acetaminophen 500 mg

    Diphenhydramine HCl 25 mg

    Pain Reliever/Nighttime Sleep-Aid

    Non-habit forming

    Rapid Release Gelcaps

    Gelcaps

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

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

    KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.

    VISIT FAMILY DOLLAR.COM

    DISTRIBUTED BY: FAMILY DOLLAR SERVICES, INC.,

    10401 MONROE RD, MATTHEWS, NC 28105 USA

  • Product Label

    Acetaminophen 500 mg, Diphenhydramine HCl 25 mg

    Family Wellness Extra Strength Pain Reliever PM

  • INGREDIENTS AND APPEARANCE
    PAIN RELIEVER PM  EXTRA STRENGTH
    acetaminophen, diphenhydramine hcl capsule
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55319-237
    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)  
    D&C RED NO. 28 (UNII: 767IP0Y5NH)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    GELATIN (UNII: 2G86QN327L)  
    HYDROXYPROPYL CELLULOSE (1600000 WAMW) (UNII: RFW2ET671P)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    WATER (UNII: 059QF0KO0R)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
    FD&C BLUE NO. 2 (UNII: L06K8R7DQK)  
    POVIDONE (UNII: FZ989GH94E)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    TRIACETIN (UNII: XHX3C3X673)  
    Product Characteristics
    ColorBLUEScoreno score
    ShapeCAPSULESize20mm
    FlavorImprint Code G3G3
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:55319-237-121 in 1 CARTON07/31/201412/30/2022
    1120 in 1 BOTTLE; Type 0: Not a Combination Product
    2NDC:55319-237-031 in 1 BOX07/31/201412/30/2022
    2300 in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart34107/31/201412/30/2022
    Labeler - Family Dollar (FAMILY WELLNESS) (024472631)

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