Label: DIPHENHYDRAMINE HCL liquid

  • NDC Code(s): 71399-0125-4, 71399-0125-6, 71399-0125-8
  • Packager: Akron Pharma Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated February 26, 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
    • 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 (1-800-222-1222) 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
    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 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

    Bubble Gum Flavor, Citric Acid, Purified Water, Sodium Benzoate, Sodium Citrate, Sodium Saccharin, Sorbitol Solution 70% & Sucrose.

  • Questions or comments?

    Please Call 1(877) 225-6999

    Manufactured for:
    Akron Pharma, Inc,
    Fairfield, NJ 07004
    Manufactured in U.S.A

  • PRINCIPAL DISPLAY PANEL

    4oz

    8oz

    16oz

  • INGREDIENTS AND APPEARANCE
    DIPHENHYDRAMINE HCL 
    diphenhydramine hcl liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71399-0125
    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)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    SODIUM CITRATE (UNII: 1Q73Q2JULR)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    SORBITOL (UNII: 506T60A25R)  
    SUCROSE (UNII: C151H8M554)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorBUBBLE GUMImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:71399-0125-4118 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product10/25/2019
    2NDC:71399-0125-8236 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product10/25/2019
    3NDC:71399-0125-6473 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product02/01/2023
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart34110/25/2019
    Labeler - Akron Pharma Inc. (067878881)
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