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: AAA;1031
Shape: C48345
Color: C48333
Ingredients: Acetaminophen; Diphenhydramine
Size: 17.00
Score: 1
Rxtty: SY
Author: AAA Pharmaceutical, Inc.
Inactive Ingredients: SILICON DIOXIDE / COPOVIDONE K25-31 / CROSCARMELLOSE SODIUM / FD&C BLUE NO. 1 / HYPROMELLOSES / LACTOSE / MAGNESIUM STEARATE / CELLULOSE, MICROCRYSTALLINE / POLYETHYLENE GLYCOLS / POVIDONES / STARCH, CORN / SODIUM STARCH GLYCOLATE TYPE A CORN / STEARIC ACID / TITANIUM DIOXIDE>

Complete Information

  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

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

    temporary relief of 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

    Allergy alert

    acetaminophen may cause severe skin reactions. Symptoms may include:

    • skin reddening
    • blisters
    • rash

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

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 other 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

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

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 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

  • Other information

  • Inactive ingredients

    colloidal silicon dioxide, copovidone, croscarmellose sodium, FD&C blue #1, hypromellose, lactose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, pregelatinized starch, sodium starch glycolate, stearic acid, titanium dioxide

  • Questions or comments?

    1-844-705-4384

  • PRINCIPAL DISPLAY PANEL

    RESTORE U

    NDC 57344-095-02

    †COMPARE TO THE ACTIVE INGREDIENTS IN TYLENOL® PM EXTRA STRENGTH CAPLETS

    FOR ADULTS

    EXTRA STRENGTH

    Pain Relief PM

    Acetaminophen, Diphenhydramine HCl

    Pain Reliever, Nighttime Sleep Aid

    Actual Size

    50 CAPLETS

    image description

  • INGREDIENTS AND APPEARANCE
    ACETAMINOPHEN PM 
    acetaminophen and diphenhydramine hydrochloride tablet, coated
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:57344-095
    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
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    COPOVIDONE K25-31 (UNII: D9C330MD8B)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    LACTOSE (UNII: J2B2A4N98G)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    POVIDONE (UNII: FZ989GH94E)  
    STARCH, PREGELATINIZED CORN (UNII: O8232NY3SJ)  
    SODIUM STARCH GLYCOLATE TYPE A CORN (UNII: AG9B65PV6B)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    ColorblueScoreno score
    ShapeOVALSize17mm
    FlavorImprint Code AAA;1031
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:57344-095-011 in 1 CARTON07/01/2017
    124 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    2NDC:57344-095-021 in 1 CARTON10/01/2012
    250 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    3NDC:57344-095-031 in 1 CARTON11/01/2017
    3100 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    4NDC:57344-095-12300 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product03/12/2024
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01310/01/2012
    Labeler - AAA Pharmaceutical, Inc. (181192162)