Label: HEALTHY MAMA EAZZZE THE PAIN- acetaminophen diphenhydramine hydrochloride tablet, film coated

  • 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 April 29, 2013

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  • Active ingredient (in each caplet)

    Acetaminophen 500 mg

    Diphenhydramine HCl 25mg


  • Purposes

    Pain RelieverNighttime Sleep Aid


  • Uses


    Temporary relief of occasional headaches and minor aches with pains with accompanying sleeplessness.


  • Warnings

    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 everyday while using this product

    When using this prodcut

    • drowsiness will occur
    • avoid alcoholic drinks
    • do not drive a motor vehicle or operate machinery

    Keep out of reach of children.

    Do not use

    • with any other drug 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 any other product containing diphenhydramine, even one used on skin
    • if you have ever had an allergic reaction to this product or any of its ingredients
  • Ask a doctor before use if you are

    • liver disease
    • a breathing problem such as emphysema or chronic bronchitis
    • difficulty in urination due to enlargement of the prostate gland
    • glaucoma

    Ask a doctor or pharmacist before use if you are

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

    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 more than 10 days
    • fever gets worse or lasts more than 3 days
    • new symptoms occur
    • redness or swelling is present. These could be signs of a serious condition.

    If pregnant or breast-feeding, ask a health 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(see overdose warning)

                   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 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


    • Store at room temperature
  • Inactive ingredients

    Povidone, Pregelatinized Starch, Sodium Starch Glycolate, Stearic Acid.

  • Questions?

    If you have any questions or comments. or to report  an adverse event, please contact (xxx) xxx-xxxx.


  • Principal Display Panel

    healthy

    mama

    eaZZZe THE PAIN!

    acetaminophen 500mg diphenhydramine HCl 25 mg

    PAIN RELIEVER AND NIGHTTIME AID

    extra strength aspirin free


    40 caplets

    Untitled.jpgUntitledd.jpgUntitleddd.jpg

  • INGREDIENTS AND APPEARANCE
    HEALTHY MAMA  EAZZZE THE PAIN
    acetaminophen diphenhydramine hydrochloride tablet, film coated
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58154-104
    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
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    CROSPOVIDONE (UNII: 68401960MK)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    POVIDONES (UNII: FZ989GH94E)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    ColorwhiteScoreno score
    ShapeOVAL (Capsule shaped tablet) Size18mm
    FlavorImprint Code GP325
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:58154-104-0140 in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34304/29/2013
    Labeler - MATERNAL SCIENCE, LLC (078722406)
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