Label: DIPHENHYDRAMINE HCL solution

  • NDC Code(s): 0904-6985-16, 0904-6985-20
  • Packager: Major Pharmaceuticals
  • Category: HUMAN OTC DRUG LABEL

Drug Label Information

Updated August 29, 2023

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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:
      • runny nose
      • sneezing
      • itchy, watery eyes
      • 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
    • difficulty in urination due to enlargement of the prostate gland
    • glaucoma

    Ask a doctor or pharmacist before use if you are

    taking sedatives or tranquilizers.

    When using this product

    • marked drowsiness may occur
    • avoid alcoholic beverages
    • alcohol, sedatives, and tranquilizers may increase drowsiness
    • excitability may occur, especially in children
    • 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 directed
    • do not take more than 6 doses in 24 hours
    • mL = milliliter
    • find right dose on chart below
    • take every 4 to 6 hours, or as directed by a doctor
    AgeDose
    adults and children 12 years and over2 - 4 teaspoonsful (25 mg to 50 mg)
    children 6 to 11 years1 - 2 teaspoonsful (12.5 mg to 25 mg)
    children 2 to 5 yearsdo not use unless directed by a doctor
    children under 2 yearsdo not use
  • Other information

    • each teaspoonful (5 mL) contains: sodium 4 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, flavor, glycerin, high fructose corn syrup, purified water, sodium benzoate, sodium chloride, sodium citrate dihydrate, sucrose

  • Questions or comments?

    1-800-426-9391

  • Principal display panel

    MAJOR®

    NDC 0904-6985-16

    Diphenhydramine HCl
    Oral Solution

    Antihistamine

    12.5 mg/5 mL

    Cherry Flavored

    Ages 6 Years and Over

    Institutional Dispensing only

    16 FL OZ (473 mL)

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

    50844    REV0523B01521
    Distributed by:
    MAJOR® PHARMACEUTICALS
    Indianapolis, IN 46268
    Questions or comments?
    Call (800) 616-2471
    www.majorpharmaceuticals.com

    Major 44-015

    Major 44-015

  • INGREDIENTS AND APPEARANCE
    DIPHENHYDRAMINE HCL 
    diphenhydramine hcl solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)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:0904-6985-20118 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product08/27/2019
    2NDC:0904-6985-16473 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product08/27/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01208/27/2019
    Labeler - Major Pharmaceuticals (191427277)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.967626305manufacture(0904-6985) , pack(0904-6985)
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