Label: DIPHENHYDRAMINE HCL ORAL SOLUTION- diphenhydramine hcl oral solution

  • NDC Code(s): 0904-7323-41, 0904-7323-70, 0904-7324-66, 0904-7324-72
  • Packager: MAJOR® PHARMACEUTICALS
  • Category: HUMAN OTC DRUG LABEL

Drug Label Information

Updated March 19, 2024

If you are a healthcare professional or from the pharmaceutical industry please visit this version.

  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient per 5 mL (1 Unit Dose)

    Diphenhydramine HCl 12.5 mg

  • Active ingredient per 10 mL (1 Unit Dose)

    Diphenhydramine HCl 25 mg

  • Purpose

    Antihistamine

  • Uses

    Temporarily relieves these symptoms due to hay fever or other 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 the child has

    • a breathing problem such as chronic bronchitis
    • glaucoma

    Ask a doctor or pharmacist before use if the child istaking sedatives or tranquilizers

    When using this product

    • marked drowsiness may occur
    • sedatives and tranquilizers may increase drowsiness
    • excitability may occur, especially in children

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

  • Directions 

    For the 5 mL Unit-Dose: 

    • take every 4 to 6 hours, or as directed by a physician

    • do not take more than 6 doses in 24 hours

    agedose
    Children under 2 years of ageDo not use
    Children 2 to under 6 years of ageDo not use unless directed by a doctor
    Children 6 to under 12 years of age5 mL (12.5 mg) to 10 mL (25 mg)

  • Directions

    For the 10 mL Unit-Dose:

    • take every 4 to 6 hours, or as directed by a physician
    • do not take more than 6 doses in 24 hours

    agedose
    Children under 6 years of age                   Do not use
    Children 6 to under 12 years of age               10 mL (25 mg)
    Adults and children 12 years of age and over 10 mL (25 mg) to 20 mL (50 mg) 

  • Other information

    • each 5 mL contains sodium: 3 mg
    • store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature]
    • do not use if lid is torn or broken

  • Inactive ingredients: citric acid, flavor, FD&C red#40, methylparaben, propylene glycol, propylparaben, purified water, sodium citrate, and sucralose

  • Questions or comments? (855) 879-4368

  • SPL UNCLASSIFIED SECTION

    Distributed by:
    MAJOR® PHARMACEUTICALS
    Indianapolis, IN 46268

    (800) 616-2471

  • PRINCIPAL DISPLAY PANEL

    MAJOR®

    NDC 0904-7323-41

    Each 5 mL Contains:

    Diphenhydramine HCL Oral Solution 

    12.5 mg/5 mL

    Antihistamine

    Delivers 5 mL • See insert

    For Institutional Use Only

    Cherry Flavor 

    MAJOR® PHARMACEUTICALS

    Indianapolis, IN 46268

    Sugar Free • Alcohol Free

    5mLPrincipalDisplay

  • PRINCIPAL DISPLAY PANEL

    MAJOR®

    NDC 0904-7324-66

    Each 10 mL Contains:

    Diphenhydramine HCL Oral Solution 

    25 mg/10 mL

    Antihistamine

    Delivers 10 mL • See insert

    For Institutional Use Only

    Cherry Flavor 

    MAJOR® PHARMACEUTICALS

    Indianapolis, IN 46268

    Sugar Free • Alcohol Free

    10mLPrincipalDisplay

  • INGREDIENTS AND APPEARANCE
    DIPHENHYDRAMINE HCL ORAL SOLUTION 
    diphenhydramine hcl oral solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0904-7323
    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
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    SODIUM CITRATE (UNII: 1Q73Q2JULR)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    WATER (UNII: 059QF0KO0R)  
    Product Characteristics
    ColorredScore    
    ShapeSize
    FlavorCHERRYImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0904-7323-70100 in 1 BOX, UNIT-DOSE01/22/2024
    1NDC:0904-7323-415 mL in 1 CUP, UNIT-DOSE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01201/22/2024
    DIPHENHYDRAMINE HCL ORAL SOLUTION 
    diphenhydramine hcl oral solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0904-7324
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M) DIPHENHYDRAMINE HYDROCHLORIDE25 mg  in 10 mL
    Inactive Ingredients
    Ingredient NameStrength
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    SODIUM CITRATE (UNII: 1Q73Q2JULR)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    WATER (UNII: 059QF0KO0R)  
    Product Characteristics
    ColorredScore    
    ShapeSize
    FlavorCHERRYImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0904-7324-72100 in 1 BOX, UNIT-DOSE01/22/2024
    1NDC:0904-7324-6610 mL in 1 CUP, UNIT-DOSE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01201/22/2024
    Labeler - MAJOR® PHARMACEUTICALS (191427277)