Label: GENEXA ACETAMINOPHEN PM EXTRA STRENGTH- acetaminophen tablet, coated

  • NDC Code(s): 69676-0063-2, 69676-0063-5
  • Packager: Genexa Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated December 12, 2023

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active ingredients (in each caplet)

    Acetaminophen 500 mg

    Diphenhydramine HCl 25 mg

  • PURPOSE

    Purpose

    Pain reliever

    Nighttime sleep aid

  • INDICATIONS & USAGE

    Uses

    temporarily relieves occasional headaches and minor aches and pains with accompanying sleeplessness

  • WARNINGS

    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 the 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
    • glaucoma
    • a breathing problem such as emphysema or chronic bronchitis
    • trouble urinating due to an enlarged prostate gland

    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

    • sleeplessness persists continuously for more than 2 weeks. Insomnia may be a symptom of serious underlying medical illness.
    • pain gets worse or lasts more than 10 days
    • fever gets worse or lasts more than 3 days
    • redness or swelling is present
    • new symptoms occur

    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). Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

  • DOSAGE & ADMINISTRATION

    Directions

    • do not take more than directed (see Overdose warning)

    adults and children 12 years and over
    • take 2 caplets at bedtime if needed
    • do not take more than 2 caplets in 24 hours, unless directed by a doctor
    children under 12 yearsask a doctor

  • OTHER SAFETY INFORMATION

    Other information

    • each caplet contains: calcium 12 mg
    • store between 20-25°C (68-77°F)
  • INACTIVE INGREDIENT

    Inactive ingredients

    acacia gum‡, agave fiber‡, agave syrup‡, calcium carbonate‡, organic carnauba wax, cellulose‡, dextrose‡, dibehenin (vegetable source)‡, glycerin‡, guar gum‡, maltodextrin‡, organic palm olein, rice extract‡, rice hulls‡, sodium bicarbonate‡, organic sunflower lecithin, sunflower oil‡

    ‡natural

  • QUESTIONS

    Questions? 1-855-436-3921

  • SPL UNCLASSIFIED SECTION

    Carton and bottle are safety sealed. DO NOT use if seal on top and/or bottom of carton or under cap of bottle is disturbed or missing.

    *This product is not manufactured or distributed by Johnson & Johnson Corp., owner of the registered trademark Tylenol® PM Extra Strength Caplets.

    Patent Pending | Distributed by: Genexa Inc.

    Atlanta, GA 30318 | genexa.com

    Made in the USA with globally sourced ingredients

    NDC 69676-0063-2

  • PRINCIPAL DISPLAY PANEL

    Genexa®

    MEDICINE MADE CLEAN

    For Adults

    Acetaminophen PM Extra Strength

    with Diphenhydramine HCl

    Pain Reliever Nighttime Sleep Aid

    Compare to active ingredients in Tylenol® PM Extra Strength Caplets*

    100 Caplets

    Non-habit forming

    How we're different

    Made without: crospovidone, polyethylene glycol, titanium dioxide & more!

    Adult APAP PM_Carton_R-20220323

  • INGREDIENTS AND APPEARANCE
    GENEXA ACETAMINOPHEN PM  EXTRA STRENGTH
    acetaminophen tablet, coated
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69676-0063
    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
    CALCIUM CARBONATE (UNII: H0G9379FGK)  
    RICE BRAN (UNII: R60QEP13IC)  
    POWDERED CELLULOSE (UNII: SMD1X3XO9M)  
    INULIN (UNII: JOS53KRJ01)  
    PALM OIL (UNII: 5QUO05548Z)  
    ACACIA (UNII: 5C5403N26O)  
    AGAVE TEQUILANA JUICE (UNII: GVG8G0207O)  
    CARNAUBA WAX (UNII: R12CBM0EIZ)  
    DEXTROSE (UNII: IY9XDZ35W2)  
    GUAR GUM (UNII: E89I1637KE)  
    MALTODEXTRIN (UNII: 7CVR7L4A2D)  
    SODIUM BICARBONATE (UNII: 8MDF5V39QO)  
    LECITHIN, SUNFLOWER (UNII: 834K0WOS5G)  
    GLYCERYL DIBEHENATE (UNII: R8WTH25YS2)  
    SUNFLOWER OIL (UNII: 3W1JG795YI)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    Product Characteristics
    Colorwhite (LIGHT BEIGE WITH SPECKLES) Scoreno score
    ShapeOVAL (Oblong) Size18mm
    FlavorImprint Code G7
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69676-0063-21 in 1 CARTON02/17/2022
    1100 in 1 BOTTLE; Type 0: Not a Combination Product
    2NDC:69676-0063-51 in 1 CARTON02/17/2022
    250 in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01302/17/2022
    Labeler - Genexa Inc. (079751024)
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