Label: ACETAMINOPHEN PM- acetaminophen, diphenhydramine hcl 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 2, 2013

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

  • Active Ingredients (in each caplet)

    Acetaminophen 500mg

    Diphenhydramine HCl 25mg

  • Purpose

    Pain reliever

    Nighttime sleep aid

  • Uses

    temporary relief of occasional headaches and minor aches and pains with accompanying sleeplessnes

  • Warnings

    • Warnings

    Liver warning:

    This product contains acetaminophen.  Severe liver damage may occur if you take

    • more than 4,000ms 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 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
    • glaucoma
    • a breathing problem such as emphysema or chronic bronchitis
    • trouble urinating due to an enlarged 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 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 serious underlying medical illness
    • pain gets worse or lasts more than 10 days
    • redness or swelling is present
    • new symptoms occur

        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.

    Enter section text here

    Overdose warning:

    Taking more than the recommended dose (overdose) may cause liver damage.  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 under 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

    • do not use if safety seal under cap is broken or missing
    • store between 20-25°C (68-77°F)
    • see end panel for lot number and expiration date
  • Inactive ingredients

    corn starch, cydroxypropyl cellulose, hypromellose 2910, blue no.1, magnesium stearate, microcrystalline cellulose, polyethylene glycol 6000, sodium starch glycolate, titanium dioxide


  • PRINCIPAL DISPLAY PANEL

    non-aspirin PM

    image of carton label

  • INGREDIENTS AND APPEARANCE
    ACETAMINOPHEN PM 
    acetaminophen, diphenhydramine hcl tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:67510-0154
    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
    STARCH, CORN (UNII: O8232NY3SJ)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    POLYETHYLENE GLYCOL 6000 (UNII: 30IQX730WE)  
    SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    Colorblue (blue) Scoreno score
    ShapeROUNDSize17mm
    FlavorImprint Code PM
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:67510-0154-21 in 1 BOX
    124 in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34301/28/2011
    Labeler - Kareway Product, Inc. (121840057)