Label: DIPHENHYDRAMINE HCL- diphenhydramine hydrochloride solution

  • NDC Code(s): 60687-829-40, 60687-829-46, 60687-829-86
  • Packager: American Health Packaging
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated August 4, 2024

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  • 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 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 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 years

    do not use

    children 2 to 5 years

    do not use unless directed by a doctor

    children 6 to 11 years

    5 mL to 10 mL
  • Other information

    • each 5 mL contains: sodium 10 mg
    • store between 20-25°C (68-77°F). Protect from light. Store in outer carton until contents used.

    Diphenhydramine HCl Oral Solution, USP is a clear, cherry flavored liquid supplied in the following:
    5 mL unit dose cups: 100 cups (10 x 10) NDC 60687-829-86

  • 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

    DO NOT USE IF SEAL IS BROKEN.

    Distributed by:
    American Health Packaging
    Columbus, OH 43217

    R02/24

  • Principal Display Panel - Label

    Diphenhydramine Hydrochloride Oral Solution USP Label

    100 Count Case NDC 60687-829-86
    Cup NDC 60687-829-40

    Diphenhydramine Hydrochloride
    Oral Solution USP

    12.5 mg/5 mL

    Antihistamine/Allergy
    Alcohol Free/Dye Free/Sugar Free

    Usual Dosage: See attached Drug Facts

    Store at 20° to 25°C (68° to 77°F)

    For Institutional Use Only

    10 x 5 mL Unit-Dose Cups

    T0865C050224       R02/24

  • Principal Display Panel – Cup – 12.5 mg/5 mL

    12.5 mg/5 mL Diphenhydramine Hydrochloride Oral Solution USP Cup Label

    NDC 60687- 829-40

    Diphenhydramine
    Hydrochloride
    Oral Solution USP

    12.5 mg/5 mL

    Antihistamine/Allergy
    Alcohol Free/Dye Free/Sugar Free

    Delivers 5 mL

    Sodium Content: 10 mg/5 ml

    See package Drug Facts insert for full
    prescribing information and storage.

    For Institutional Use Only.

    American Health Packaging
    Columbus, OH 43217

    A0865C050224

  • INGREDIENTS AND APPEARANCE
    DIPHENHYDRAMINE HCL 
    diphenhydramine hydrochloride solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:60687-829
    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, UNSPECIFIED (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:60687-829-8610 in 1 CASE08/04/2024
    1NDC:60687-829-4610 in 1 TRAY
    1NDC:60687-829-405 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 DrugM01208/04/2024
    Labeler - American Health Packaging (929561009)
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