Label: PAIN RELIEF PM- acetaminophen and diphenhydramine hydrochloride tablet, coated

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

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Drug Label Information

Updated February 5, 2010

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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, minor aches, and pains accompanying sleeplessness.

  • Warnings

    Liver warning: This product contains acetaminophen. Severe liver damage may occur with this product if you take:

    • more than 2 caplets in 24 hours, which is the maximum daily amount
    • with other drugs containing acetaminophen
    • 3 or more alcoholic drinks every day while using this product

    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. Prompt medical attention is critical for adults as well as children even if you do not notice any signs or symptoms.

    Do not use

    • with other products containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
    • 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
    • breathing problems such as emphysema or chronic bronchitis
    • glaucoma
    • difficulty in urinating due to an enlargement of the prostate gland

    Ask a doctor or pharmacist before use if you are

    • taking sedatives or tranquilizers
    • taking the blood thinning drug warfarin

    When using this product

    avoid alcoholic beverages

    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 a serious underlying medical illness.
    • pain gets worse or lasts for more than 10 days
    • fever gets worse or lasts for more than 3 days
    • new symptoms occur
    • redness or swelling is present

    If pregnant or breast-feeding, ask a health care professional before use. Keep out of reach of children.

  • Directions

    • do not exceed recommended dose
    • adults and children 12 years of age and over: take 2 caplets at bedtime. Do not take more than 2 caplets in 24 hours.
    • children under 12 years of age: do not use this 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 room temperature 15°-30°C (59°-86°F), avoid high humidity and excessive heat
    • do not use if imprinted safety seal under cap is broken or missing
  • Inactive ingredients

    FD&C Blue #1 Aluminum Lake, magnesium stearate, microcrystalline cellulose, polyethylene glycol (PEG), polyvinyl alcohol, polyvinylpyrrolidone, sodium carboxymethyl starch, starch, stearic acid, talc, titanium dioxide.

  • Package/Label Principal Display Panel

    Pain Relief PM Packaging Label

    NDC 63548-2341-*1

    SEE NEW WARNINGS INFORMATION

    EXTRA STRENGTH

    Pain Relief PM

    Pain reliever

    Nighttime Sleep-Aid

    Acetaminophen 500 mg

    Diphenhydramine HCl 25 mg

    24 CAPLETS


    Do not use if imprinted safety seal under cap is broken or missing

  • INGREDIENTS AND APPEARANCE
    PAIN RELIEF PM 
    acetaminophen and diphenhydramine hydrochloride tablet, coated
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63548-2341
    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
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
    POLYVINYL ALCOHOL (UNII: 532B59J990)  
    POVIDONE K30 (UNII: U725QWY32X)  
    CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    TALC (UNII: 7SEV7J4R1U)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    ColorBLUEScoreno score
    ShapeCAPSULESize7mm
    FlavorImprint Code V15
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:63548-2341-124 in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    Unapproved drug other01/02/2010
    Labeler - Avema Pharma Solutions (804087749)
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