PAIN RELIEF PM (ACETAMINOPHEN, ASPIRIN, DIPHENHYDRAMINE CITRATE) TABLET, FILM COATED [CVS PHARMACY]

PAIN RELIEF PM (ACETAMINOPHEN, ASPIRIN, DIPHENHYDRAMINE CITRATE) TABLET, FILM COATED [CVS PHARMACY]
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NDC 59779-894-12
Set ID ddd78b28-6e10-4708-bed1-8aea087b3d82
Category HUMAN OTC DRUG LABEL
Packager CVS Pharmacy
Generic Name
Product Class
Product Number
Application Number PART343
  • Active ingredients (in each caplet)

    Acetaminophen 250 mg
    Aspirin 250 mg (NSAID)*
    Diphenhydramine citrate 38 mg
    *nonsteroidal anti-inflammatory drug

  • Purpose

    Pain reliever
    Pain reliever
    Nighttime sleep-aid

  • Uses

    for the temporary relief of occasional headaches and minor aches and pains with accompanying sleeplessness

  • Warnings

    Reye's syndrome: Children and teenagers who have or are recovering from chicken pox or flu-like symptoms should not use this product. When using this product, if changes in behavior with nausea and vomiting occur, consult a doctor because these symptoms could be an early sign of Reye's syndrome, a rare but serious illness.

    Allergy alert: Aspirin may cause a severe allergic reaction, which may include:

    • hives
    • facial swelling
    • shock
    • asthma (wheezing)

    Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include:

    • blisters
    • rash
    • skin reddening

    If a skin reaction occurs, stop use and seek medical help right away.

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

    • more than 4,000 mg of acetaminophen in 24 hours
    • with other drugs containing acetaminophen
    • 3 or more alcoholic drinks every day while using this product

    Stomach bleeding warning: This product contains an NSAID, which may cause severe stomach bleeding. The chance is higher if you

    • are age 60 or older
    • take more or for a longer time than directed
    • take other drugs containing prescription or nonprescription NSAIDs [aspirin, ibuprofen, naproxen, or others]
    • have had stomach ulcers or bleeding problems
    • take a blood thinning (anticoagulant) or steroid drug
    • have 3 or more alcoholic drinks every day while using this product

    Do not use

    • if you have ever had an allergic reaction to acetaminophen, aspirin, or any other pain reliever/fever reducer
    • with any other drug containing acetaminophen (prescription or nonprescription). 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

    Ask a doctor before use if

    • stomach bleeding warning applies to you
    • you have a history of stomach problems, such as heartburn
    • you have difficulty in urination due to enlargement of the prostate gland
    • you have liver disease
    • you have a breathing problem such as emphysema or chronic bronchitis
    • you are taking a diuretic
    • you have high blood pressure, heart disease, liver cirrhosis, or kidney disease
    • you have glaucoma
    • you have asthma

    Ask a doctor or pharmacist before use if you are taking

    • a prescription drug for:
      • diabetes
      • gout
      • arthritis
    • any other drug, or are under a doctor’s care for any serious condition
    • sedatives or tranquilizers
    • any product that contains aspirin, acetaminophen, or any other pain reliever/fever reducer

    When using this product

    • avoid alcoholic beverages
    • drowsiness may occur
    • do not drive a motor vehicle or operate machinery

    Stop use and ask a doctor if

    • an allergic reaction occurs. Seek medical help right away.
    • you experience any of the following signs of stomach bleeding:
      • feel faint
      • vomit blood
      • have bloody or black stools
      • have stomach pain that does not get better
    • ringing in the ears or a loss of hearing occurs
    • 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
    • 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. It is especially important not to use aspirin during the last 3 months of pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery.

    Keep out of reach of children.

    In case of accidental overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away. Prompt 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, with a full glass of water
    • do not take more than 2 caplets in 24 hours, unless directed by a doctor
    • children under 12 years: do not use
  • Other information

    • store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)
    • see end flap for expiration date and lot number
  • Inactive ingredients

    corn starch, crospovidone, FD&C blue #1 aluminum lake, hypromellose, maltodextrin, medium chain triglycerides, microcrystalline cellulose, polydextrose, povidone, sodium lauryl sulfate, sodium starch glycolate, sodium sulfate, stearic acid, talc, titanium dioxide, yellow iron oxide, zinc stearate

  • Questions or comments?

    1-800-426-9391

  • Principal Display Panel

    ♥︎CVSHealth™

    Compare to the active ingredients
    in Excedrin® PM Headache

    Caplets

    Pain Relief PM
    ACETAMINOPHEN,
    250 mg
    ASPIRIN (NSAID), 250 mg
    DIPHENHYDRAMINE CITRATE, 38 mg

    Pain reliever, Nighttime sleep-aid

    • Non-habit forming
    • For pain with sleeplessness

    100 CAPLETS

    Actual Size

    Package Contains One Bottle

    TAMPER EVIDENT: DO NOT USE IF IMPRINTED
    SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

    This product is not manufactured or distributed by Novartis
    AG, owner of the registered trademark Excedrin® PM
    Headache.  50844      ORG041867412

    Distributed by: CVS Pharmacy, Inc.
    One CVS Drive, Woonsocket, RI 02895
    © 2019 CVS/pharmacy   CVS.com®  1-800-SHOP CVS V-11112

    44-674

    44-674

  • INGREDIENTS AND APPEARANCE
    PAIN RELIEF PM 
    acetaminophen, aspirin, diphenhydramine citrate tablet, film coated
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59779-894
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN250 mg
    ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E) ASPIRIN250 mg
    DIPHENHYDRAMINE CITRATE (UNII: 4OD433S209) (DIPHENHYDRAMINE - UNII:8GTS82S83M) DIPHENHYDRAMINE CITRATE38 mg
    Inactive Ingredients
    Ingredient NameStrength
    STARCH, CORN (UNII: O8232NY3SJ)  
    CROSPOVIDONE (UNII: 2S7830E561)  
    FD&C BLUE NO. 1 ALUMINUM LAKE (UNII: J9EQA3S2JM)  
    HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
    MALTODEXTRIN (UNII: 7CVR7L4A2D)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    POLYDEXTROSE (UNII: VH2XOU12IE)  
    POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    SODIUM SULFATE (UNII: 0YPR65R21J)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    TALC (UNII: 7SEV7J4R1U)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    ZINC STEARATE (UNII: H92E6QA4FV)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
    Product Characteristics
    ColorblueScoreno score
    ShapeOVALSize17mm
    FlavorImprint Code 674
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:59779-894-121 in 1 CARTON08/31/2016
    1100 in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34308/31/2016
    Labeler - CVS Pharmacy (062312574)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.967626305pack(59779-894)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.868734088pack(59779-894)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.038154464pack(59779-894)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.832867894manufacture(59779-894)

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