Label: DIPHENHYDRAMINE HCL 12.5MG ANTIHISTAMINE- diphenhydramine hydrochloride bar, chewable

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph 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 February 24, 2021

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  • SPL UNCLASSIFIED SECTION

    Diphenhydramine HCl 12.5 mg Soft Chews

    Alexso, Inc.

    ----------------

    Diphenhydramine HCl 12.5 mg Soft Chews

    DRUG FACTS

  • ACTIVE INGREDIENT (in each soft chew)

    Diphenhydramine HCl 12.5mg

  • PURPOSE

    Antihistamine

  • USES

    Temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:

    • Runny nose
    • Itchy, watery eyes
    • Sneezing
    • Itching of the nose or throat
  • WARNINGS

    Do not use

    • To make child sleepy
    • With any other product containing diphenhydramine, even one used on skin

    Ask a doctor before use if you have

    • A breathing problem such as emphysema or chronic bronchitis
    • Glaucoma
    • Trouble urinating due to an enlarged prostate gland

    Ask a doctor or pharmacist before use if

    you are taking sedatives or tranquilizers

    When using this product

    • Excitability may occur, especially in children
    • Marked drowsiness may occur
    • Avoid alcoholic drinks
    • Alcohol, sedatives, and tranquilizers may increase drowsiness
    • Be careful when driving a motor vehicle or operating machinery

    If pregnant or breast-feeding,

    ask a health professional before use.

    Keep out of reach of children.

    In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

  • DIRECTIONS

    Adults and children 12 years and over:

    • Take 2 to 4 soft chews (25 mg to 50 mg) every 4 to 6 hours, or as directed by a doctor
    • Do not take more than 6 times in 24 hours
    • Chew each soft chew thoroughly before swallowing

    Children 6 to 11 years:

    • Take 1 to 2 soft chews (12.5 mg to 25 mg) every 4 to 6 hours, or as directed by a doctor.
    • Do not take more than 6 times in 24 hours
    • Chew each soft chew thoroughly before swallowing

    Children under 6 years: Do not use

  • OTHER INFORMATION

    • each soft chew contains: sodium 7 mg. Very low sodium.
    • store in a cool dry place between 20-25°C (68-77°F).
    • Child Resistant Container; do not use if printed seal under cap is broken or missing.
  • Inactive ingredients:

    citric acid, flavor, glucose syrup, hydroxypropyl betadex, magnesium stearate, maltitol solution, maltodextrin, mineral oil, neotame, purified water, seaweed extract (carrageenan), sodium chloride, starch, sucralose, sucrose, trisodium citrate dihydrate.

  • Questions or comments?

    Call 888-495-6078

  • HOW SUPPLIED

    Diphenhydramine 12.5mg Soft Chews is supplied in the following dosage form:

    Twenty (20) Soft Chews per container

    ***Made in USA***

    Manufactured for:
    Alexso, Inc.
    2317 Cotner Ave
    Los Angeles, CA 90064

    NDC: 50488-4125-1
    Size: 20 Soft Chews

  • PRINCIPAL DISPLAY PANEL

    Diphenhydramine HCl 12.5 mg Soft Chews
    20 Bubble Gum Flavored Gummies

    Chewy Gummy Bites
    NDC: 50488-4125-1 Patent Pending

    Diphenhydramine HCl 12.5 mg Soft Chews 20 Bubble Gum Flavored Gummies Chewy Gummy Bites NDC:50488-4125-1 Patent Pending

  • INGREDIENTS AND APPEARANCE
    DIPHENHYDRAMINE HCL 12.5MG ANTIHISTAMINE 
    diphenhydramine hydrochloride bar, chewable
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50488-4125
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M) DIPHENHYDRAMINE HYDROCHLORIDE12.5 mg
    Inactive Ingredients
    Ingredient NameStrength
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    ANHYDROUS DEXTROSE (UNII: 5SL0G7R0OK)  
    HYDROXYPROPYL BETADEX (UNII: 1I96OHX6EK)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MALTITOL (UNII: D65DG142WK)  
    MALTODEXTRIN (UNII: 7CVR7L4A2D)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    NEOTAME (UNII: VJ597D52EX)  
    WATER (UNII: 059QF0KO0R)  
    CARRAGEENAN (UNII: 5C69YCD2YJ)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    CORN SYRUP (UNII: 9G5L16BK6N)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    SUCROSE (UNII: C151H8M554)  
    TRISODIUM CITRATE DIHYDRATE (UNII: B22547B95K)  
    Product Characteristics
    ColorYELLOW (Light yellow to golden brown) Scoreno score
    ShapeRECTANGLESize18mm
    FlavorBUBBLE GUMImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:50488-4125-120 in 1 BOTTLE; Type 0: Not a Combination Product02/08/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart34102/08/2021
    Labeler - Alexso, Inc (963338061)
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