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: AZ;020
Shape: C48345
Color: C48333
Ingredients: Acetaminophen; Diphenhydramine
Size: 17.00
Score: 2
Rxtty: SY
Author: Eagle Distributors,Inc.
Inactive Ingredients: croscarmellose sodium / FD&C blue no. 1 / hypromelloses / cellulose, microcrystalline / polyethylene glycols / povidone / stearic acid / titanium dioxide / polyvinyl alcohol / silicon dioxide / talc>

Complete Information

  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active ingredients (in each caplet)Purposes
    Acetaminophen 500 mgPain reliever
    Diphenhydramine HCl 25 mgNighttime sleep aid
  • Uses

    temporarily relieves occasional headaches and minor aches and 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 every day while using this product

    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.
    • with any product containing diphenhydramine, even one used on skin
    • 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
  • a breathing problem such as emphysema or chronic bronchitis
  • trouble urinating due to an enlarged prostate gland
  • glaucoma

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

These could be signs of a serious condition.

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

Keep out of reach of children.

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

    Adults and children 12 years of age and overTake 2 caplets at bedtime. Do not take more than 2 caplets of this product in 24 hours.
    Children under 12 years of ageDo not use this adult strength product. This will provide more than the recommended dose (overdose) and could cause serious health problems
  • Other information

  • Inactive ingredients

    croscarmellose sodium, FD&C blue #1, hypromellose, microcrystalline cellulose, polyethylene glycol, povidone, starch, stearic acid, titanium dioxide. May contain polyvinyl alcohol, silicon dioxide, sodium starch glycolate, talc.

  • Questions or comments?

    Call 1-800-570-8650 (M-F 9am to 5pm PST)

  • SPL UNCLASSIFIED SECTION

    Product manufactured for:
    Eagle Distributors,Inc.
    Los Angeles, CA 90011

  • PRINCIPAL DISPLAY PANEL - 50 Pouch Carton

    See New Warnings Information & Directions
    Compare to the Active Ingredients in
    Tylenol PM®*

    Extra Strength
    PM
    Get Relief
    Pain Reliever
    Nighttime Sleep Air

    Acetaminophen, Diphenhydramine HCI

    PRINCIPAL DISPLAY PANEL - 50 Pouch Carton
  • INGREDIENTS AND APPEARANCE
    PM GET RELIEF 
    acetaminophen and diphenhydramine hydrochloride tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68737-224
    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)  
    FD&C blue no. 1 (UNII: H3R47K3TBD)  
    hypromelloses (UNII: 3NXW29V3WO)  
    cellulose, microcrystalline (UNII: OP1R32D61U)  
    polyethylene glycols (UNII: 3WJQ0SDW1A)  
    povidone (UNII: FZ989GH94E)  
    stearic acid (UNII: 4ELV7Z65AP)  
    titanium dioxide (UNII: 15FIX9V2JP)  
    polyvinyl alcohol (UNII: 532B59J990)  
    silicon dioxide (UNII: ETJ7Z6XBU4)  
    talc (UNII: 7SEV7J4R1U)  
    Product Characteristics
    ColorBLUEScore2 pieces
    ShapeOVAL (Capsule shape) Size17mm
    FlavorImprint Code AZ;020
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:68737-224-0850 in 1 BOX
    12 in 1 POUCH
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34106/30/2012
    Labeler - Eagle Distributors,Inc. (929837425)