Label: PAIN RELIEF PM- acetaminophen pm tablet

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

DISCLAIMER: Most OTC drugs are not reviewed and approved by 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 August 25, 2013

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

  • 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)