Label: DIPHENHYDRAMINE HCL- diphenhydramine hydrochloride solution

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated August 1, 2025

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient  (in each 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 no 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 is taking 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 overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222)

  • Directions:

    • find right dose on chart below
    • mL = milliliter
    • take every 4 to 6 hours, or as directed by a doctor
    • do not take more than 6 doses in 24 hours
    Age (yr) Dose (mL)
    children under 2 yearsdo not use
    children 2 to 5 yearsdo not use unless directed by a doctor
    children 6 to 11 years5 mL to 10 mL
  • Other information

    • each 5 mL contains: sodium 10 mg
    • store between 20° to 25°C (68° to 77°F).

    Diphenhydramine HCl Oral Solution, USP is a clear, cherry flavored liquid supplied in the following:

    NDC  0904-7560-41:  5 mL unit dose cup, in a tray of 10 cups.
    NDC  0904-7559-66:  10 mL unit dose cup, in a tray of 10 cups.

  • Inactive ingredients:

    citric acid anhydrous, glycerin, flavoring, purified water, saccharin sodium, sodium benzoate, sodium carboxymethylcellulose, sodium citrate, sorbitol.

  • Questions or comments?

    Call 1-800-845-8210

    R02/25

    Distributed by:

    MAJOR® PHARMACEUTICALS
    Indianapolis, IN  46268

  • PRINCIPAL DISPLAY PANEL

    Delivers 5 mL

    NDC0904-7560-41

    Diphenydramine HCl Oral Solution USP

    12.5 mg/5 mL

    Lidding for Diphenhydramine HCl Oral Solution USP 5 mL UD Cup
  • PRINCIPAL DISPLAY PANEL

    Delivers 10 mL

    NDC0904-7559-66

    Diphenydramine HCl Oral Solution USP

    25 mg/10 mL

     

    Lidding for Diphenhydramine HCl Oral Solution USP 10 mL UD Cup

  • INGREDIENTS AND APPEARANCE
    DIPHENHYDRAMINE HCL 
    diphenhydramine hydrochloride solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0904-7560(NDC:0121-0865)
    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)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    WATER (UNII: 059QF0KO0R)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)  
    SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)  
    SORBITOL (UNII: 506T60A25R)  
    Product Characteristics
    Colorwhite (CLEAR) Score    
    ShapeSize
    FlavorCHERRYImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0904-7560-7010 in 1 CASE08/01/2025
    110 in 1 TRAY
    1NDC:0904-7560-415 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 DrugM01207/15/2025
    DIPHENHYDRAMINE HCL 
    diphenhydramine hydrochloride solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0904-7559(NDC:0121-1730)
    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
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    WATER (UNII: 059QF0KO0R)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)  
    SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)  
    SORBITOL (UNII: 506T60A25R)  
    Product Characteristics
    Colorwhite (CLEAR) Score    
    ShapeSize
    FlavorCHERRYImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0904-7559-7210 in 1 CASE08/01/2025
    110 in 1 TRAY
    1NDC:0904-7559-6610 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 DrugM01207/15/2025
    Labeler - Major Pharmaceuticals (191427277)
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