Label: FRIDABABY CHILDREN ALLERGY RELIEF DIPHENHYDRAMINE HCL 12.5MG PER 5ML VIAL , 15CT- diphenhydramine hcl 12.5mg / 5ml solution

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

Drug Label Information

Updated December 19, 2023

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  • Active Ingredient (in each 5mL)

    Diphenhydramine HCL 12.5mg

  • Purpose

    Antihistamine

  • Uses

    Temporarily relieves runny nose and reduces sneezing, itching of the nose or throat, and itchy, watery eyes due to hay fever or other upper respiratory allergies.

  • 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

    ■ a sodium-restricted diet

    Ask a doctor or pharmacist before use if the child is

    taking any sedatives or tranquilizers

    When using this product

    ■ excitability may occur, especially in children

    ■ marked drowsiness may occur

    ■ sedatives and tranquilizers may increase the drowsiness effect

    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

    ■ this product does not contain directions or complete warnings for adult use

    ■ give the recommended number of vials below following the instructions: 1. Tap the vial to eliminate air bubbles; 2. Twist the top of the vial off; 3. Squeeze the liquid into child’s mouth.

    ■ empty each Single Use Vial required of all liquid when dosing.

    ■ do not give more than 6 doses in 24 hours

    Dosing chart

    Age (years)Dose
    6-11 years1-2 Single Use Vial (5 mL each) every 4 – 6 hours. Do not exceed 12 vials in 24 hours

  • Other Information

    ■ Each Single Use Vial contains 16mg of sodium

    ■ Store at 68-77°F (20-25°C)

    ■ Tamper Evident: do not use if top flap of carton is open. Do not use if any vial is open or broken.

  • Inactive Ingredients

    citric acid, glycerin, mixed berry flavor, propylene glycol, purified water, sodium benzoate, sorbitol, strawberry flavor, sucralose, trisodium citrate dihydrate, xanthan gum.

  • Questions or Comments?

    1-833-WTF-FRIDA (1-833-983-3743)

  • Package

    PDPDrug Facts Label

  • INGREDIENTS AND APPEARANCE
    FRIDABABY CHILDREN ALLERGY RELIEF DIPHENHYDRAMINE HCL 12.5MG PER 5ML VIAL , 15CT 
    diphenhydramine hcl 12.5mg / 5ml solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72705-125
    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)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    SORBITOL (UNII: 506T60A25R)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    TRISODIUM CITRATE DIHYDRATE (UNII: B22547B95K)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorBERRYImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:72705-125-1515 in 1 POUCH08/16/2022
    15 mL in 1 VIAL; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01208/16/202207/31/2024
    Labeler - Fridababy LLC (783729598)
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