Home > Pill Identifier > APAP 500 MG / diphenhydramine hydrochloride 25 MG Oral Tablet

Pill Identifier Information of APAP 500 MG / diphenhydramine hydrochloride 25 MG Oral Tablet

Drug Information

APAP 500 MG / diphenhydramine hydrochloride 25 MG Oral Tablet

Imprint: GP325
Shape: C48345
Color: C48325
Ingredients: Acetaminophen; Diphenhydramine
Size: 18.00
Score: 1
Rxtty: SY
Author: MATERNAL SCIENCE, LLC
Inactive Ingredients: CROSCARMELLOSE SODIUM / CROSPOVIDONE / FD&C BLUE NO. 1 / HYPROMELLOSES / MAGNESIUM STEARATE / CELLULOSE, MICROCRYSTALLINE / POVIDONES / PROPYLENE GLYCOL / SILICON DIOXIDE / STEARIC ACID / TITANIUM DIOXIDE>

Complete Information

  • 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

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  • 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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