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Pain Relief PM (Avema Pharma Solutions)

Available Formats

Dosage Form Package Information Links
TABLET, COATED 1 BOTTLE in 1 BOX (63548-0065-1) > 24 TABLET, COATED in 1 BOTTLE Label Information

Complete Pain Relief PM Information

  • 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


    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
    • 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
    • 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 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 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
    • redness or swelling is present
    • new symptoms occur

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

    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 (1-800-222-1222). 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
    • 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 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
    • **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*, Dand C Yellow No. 10 Aluminum Lake*, FDandC Blue No.1 Aluminum Lake, FDandC Blue No. 2 Aluminum Lake, hypromellose, magnesium silicate*, magnesium stearate*, microcrystalline cellulose, mineral oil*, polyethylene glycol,
    polyvinyl alcohol*, povidone, pregelatinized starch, silica*, sodium starch glycolate*, stearic acid, talc*, titanium dioxide, triacetin*, and yellow iron oxide*

    *contains one or more of these ingredients
  • Product Labeling

    **Compare to the active
    ingredients in Tylenol® PM®


    EXTRA STRENGTH

    Pain Relief PM

    Acetaminophen 500 mg, Diphenhydramine HCl 25 mg

    Pain reliever /
    Nighttime Sleep-Aid

    24 CAPLETS


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


    Pain Relief PM

    Pain Relief PM


  • INGREDIENTS AND APPEARANCE
    PAIN RELIEF PM 
    acetaminophen, diphenhydramine hcl tablet, coated
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:63548-0065
    Route of Administration ORAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN 500 mg
    DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M) DIPHENHYDRAMINE HYDROCHLORIDE 25 mg
    Inactive Ingredients
    Ingredient Name Strength
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A)  
    POLYVINYL ALCOHOL (UNII: 532B59J990)  
    POVIDONE (UNII: FZ989GH94E)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    SODIUM STARCH GLYCOLATE TYPE A CORN (UNII: AG9B65PV6B)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    TALC (UNII: 7SEV7J4R1U)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    TRIACETIN (UNII: XHX3C3X673)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    Product Characteristics
    Color BLUE Score no score
    Shape CAPSULE Size 7mm
    Flavor Imprint Code V15AV;S525;CPC752
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:63548-0065-1 1 in 1 BOX
    1 24 in 1 BOTTLE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part343 05/14/2012
    Labeler - Avema Pharma Solutions (804087794)