Label: DIPHENHYDRAMINE HCL solution

  • Category: HUMAN OTC DRUG LABEL

Drug Label Information

Updated April 10, 2024

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  • Active ingredient (in each teaspoonful (5 mL))

    Diphenhydramine HCl 12.5 mg

  • Purpose

    Antihistamine

  • Uses

    •
    temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:
    o
    runny nose
    o
    sneezing
    o
    itchy, watery eyes
    o
    itching of the nose or throat
  • Warnings

    Do not use

    •
    to make a 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
    •
    difficulty in urination due to enlargement of the prostate gland

    Ask a doctor or pharmacist before use if you are

    taking sedatives or tranquilizers.

    When using this product

    •
    avoid alcoholic beverages
    •
    alcohol, sedatives, and tranquilizers may increase drowsiness
    •
    excitability may occur, especially in children
    •
    marked drowsiness may occur
    •
    use caution 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 right away.

  • Directions

    •
    do not take more than 6 doses in 24 hours
    •
    mL = milliliter; FL OZ = fluid ounce
    •
    find right dose on chart below
    •
    take every 4 to 6 hours, or as directed by a doctor

    Age

    Dose

    adults and children 12 years and over

    2 - 4 teaspoonsful (25 mg to 50 mg)

    children 6 to 11 years

    1 - 2 teaspoonsful (12.5 mg to 25 mg)

    children 2 to 5 years

    do not use unless directed by a doctor

    children under 2 years

    do not use
  • Other information

    •
    each teaspoonful (5 mL) contains: sodium 5 mg
    •
    store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)
    •
    use by expiration date on package
  • Inactive ingredients

    anhydrous citric acid, D&C red #33, FD&C red #40, flavors, glycerin, high fructose corn syrup, purified water, sodium benzoate, sodium chloride, sodium citrate dihydrate, sucrose

  • Questions or comments?

    (800) 616-2471

    Relabeled By: Preferred Pharmaceuticals Inc.

  • Principal display panel

    MAJOR®

    NDC 68788-8274-1

    Relabeled By: Preferred Pharmaceuticals Inc.

    Diphenhydramine HCl
    Oral Solution

    Antihistamine

    12.5 mg/5 mL

    Institutional Dispensing only

    Cherry Flavored
    Alcohol Free

    TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

    50844     REV1019A01521
    Distributed by: MAJOR® PHARMACEUTICALS
    Livonia, MI 48152
    Rev. 03/21    M-17      

    Relabeled By: Preferred Pharmaceuticals Inc.

    Diphenhydramine HCl Oral Solution 125mg/5mL
  • INGREDIENTS AND APPEARANCE
    DIPHENHYDRAMINE HCL 
    diphenhydramine hcl solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68788-8274(NDC:0904-6985)
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M) DIPHENHYDRAMINE HYDROCHLORIDE12.5 mg  in 5 mL
    Inactive Ingredients
    Ingredient NameStrength
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    HIGH FRUCTOSE CORN SYRUP (UNII: XY6UN3QB6S)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    TRISODIUM CITRATE DIHYDRATE (UNII: B22547B95K)  
    SUCROSE (UNII: C151H8M554)  
    Product Characteristics
    ColorredScore    
    ShapeSize
    FlavorCHERRYImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:68788-8274-1118 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product10/14/2022
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph Drug34110/14/2022
    Labeler - Preferred Pharmaceuticals Inc. (791119022)
    Registrant - Preferred Pharmaceuticals Inc. (791119022)
    Establishment
    NameAddressID/FEIBusiness Operations
    Preferred Pharmaceuticals Inc.791119022RELABEL(68788-8274)
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