PAIN RELIEF PM (ACETAMINOPHEN PM) TABLET [VELOCITY PHARMA]

PAIN RELIEF PM (ACETAMINOPHEN PM) TABLET [VELOCITY PHARMA]
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NDC 76168-011-04
Set ID 1a49129b-381d-4be4-baa1-c1ba5f00b312
Category HUMAN OTC DRUG LABEL
Packager Velocity Pharma
Generic Name
Product Class
Product Number
Application Number PART343
  • Active Ingredient

    (in each tablet)

    Acetaminophen 500mg

    Diphenhydramine HCl 25mg

  • Purpose

    pain reliever/fever reducer

    Nighttime sleep aid

  • Uses

    • temporarily 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 4000 mg of acetaminophen in 24 hours
    • with other drugs containing acetaminophen
    • 3 or more alcoholic drinks everyday while using this product

    Overdose warning: Taking more than recommended dose (overdose) may cause liver damage. In case of overdose, get medical help or contact a Poison Control Center right away. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

    do not use

    • with any other drug containing acetaminophen (prescription or not prescription). 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
    • With other products containing diphenhydramine, even one used on skin.

    ask a doctor before use if you have

    • liver disease
    • asthma
    • a breathing problem such as emphysema or chronic bronchitis
    • trouble urinating due to an enlarged prostate gland
    • galucoma

    ask your doctor or pharmacist before use if you are

    • taking the blood thinning drug warfarin
    • taking sedative or tranquilizers.

    When using this product

    • avoid alcoholic drinks
    • do not drive a motor vehicle or operate machinery, this product will cause drowsiness

    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.
  • Keep out of reach of children.

    If pregnant or breast-feeding, ask a health professional before use.

  • Directions

    • do not exceed recommended dose
    • 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 25 °C (77°F) excursions permitted between 15-30°C(59-86°F)
    • 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 Tylenol PM

  • Inactive Ingredients

    Colloidal Silicon Dioxide, Croscarmellose Sodium, FD&C blue #1 aluminum lake, FD&C blue #2 aluminum lake, hypromellose, microcrystalline cellulose, polyethylene glycol, povidone,  pregelatinized starch, purified water, Sodium metabisulfite, Sodium starch glycolate, stearic acid, Titanium Dioxide, Talc

  • Questions or Comments

    Call toll free 1-855-314-1850

  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

    e0595668-figure-01

    e0595668-figure-02

    NDC: 76168-011-04   24 COUNT

  • INGREDIENTS AND APPEARANCE
    PAIN RELIEF PM 
    acetaminophen pm tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76168-011
    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
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    FD&C BLUE NO. 2 (UNII: L06K8R7DQK)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    POVIDONE (UNII: FZ989GH94E)  
    SODIUM METABISULFITE (UNII: 4VON5FNS3C)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
    TALC (UNII: 7SEV7J4R1U)  
    POLYETHYLENE GLYCOL 1000 (UNII: U076Q6Q621)  
    Product Characteristics
    ColorBLUEScoreno score
    ShapeCAPSULESize18mm
    FlavorImprint Code 131
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:76168-011-0424 in 1 BOTTLE
    11 in 1 CARTON
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34312/05/2012
    Labeler - Velocity Pharma (962198409)

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