PAIN RELIEF PM (ACETAMINOPHEN, ASPIRIN, DIPHENHYDRAMINE CITRATE) TABLET, FILM COATED [AMERISOURCE BERGEN]

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  • PAIN RELIEF PM (ACETAMINOPHEN, ASPIRIN, DIPHENHYDRAMINE CITRATE) TABLET, FILM COATED [AMERISOURCE BERGEN]

PAIN RELIEF PM (ACETAMINOPHEN, ASPIRIN, DIPHENHYDRAMINE CITRATE) TABLET, FILM COATED [AMERISOURCE BERGEN]
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NDC 46122-456-71
Set ID f56c438a-0593-421f-8a7c-903d1874c8ea
Category HUMAN OTC DRUG LABEL
Packager Amerisource Bergen
Generic Name
Product Class
Product Number
Application Number PART343
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  • 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
    • shock
    • facial swelling
    • 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 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

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

    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

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

    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

    • drowsiness may occur
    • be careful when driving a motor vehicle or operating machinery
    • avoid alcoholic beverages

    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
    • pain gets worse or lasts for more than 10 days
    • painful area is red or swollen
    • new symptoms occur
    • 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.

    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

     GOOD
     NEIGHBOR
     PHARMACY®

    Compare to Excedrin® PM Headache active ingredients†

    NDC 46122-456-71

    Pain Relief PM
    acetaminophen
    aspirin (NSAID) & diphenhydramine citrate

    Pain Reliever / Nighttime Sleep Aid

    •Caffeine free

    50 Caplets ι • Non-habit forming

    Actual Size

    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       ORG011767415

    Distributed By
    AmerisourceBergen
    1300 Morris Drive
    Chesterbrook, PA 19087
    Questions or Concerns?
    www.mygnp.com

    GOOD NEIGHBOR PHARMACY BRAND PRODUCTS
    SATISFACTION GUARANTEED

    Good Neighbor Pharmacy 44-674

    Good Neighbor Pharmacy 44-674

  • INGREDIENTS AND APPEARANCE
    PAIN RELIEF PM 
    acetaminophen, aspirin, diphenhydramine citrate tablet, film coated
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:46122-456
    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)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    POLYDEXTROSE (UNII: VH2XOU12IE)  
    POVIDONE (UNII: FZ989GH94E)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    SODIUM SULFATE (UNII: 0YPR65R21J)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    TALC (UNII: 7SEV7J4R1U)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    ZINC STEARATE (UNII: H92E6QA4FV)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    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:46122-456-711 in 1 CARTON08/31/2016
    150 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 - Amerisource Bergen (007914906)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.832867894MANUFACTURE(46122-456)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.868734088PACK(46122-456)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.038154464PACK(46122-456)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.967626305PACK(46122-456)
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