Label: CHILDRENS ALLERGY RELIEF- diphenhydramine hydrochloride solution

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

Drug Label Information

Updated December 15, 2023

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  • DRUG FACTS

  • Active Ingredient (in each 5mL)

    Diphenhydramine HCL 12.5mg

    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 your 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 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

    • this product does not contain directions or complete warnings for adult use
    • give the recommended number of vials below following the instructions under Easy to Use on the side panel
    • do not take more than 6 doses in any 24 hour period
    • empty each Single-Use Vial of all liquid when dosing

    Dosing Chart

    Age (Years)Dose
    6 - 11 years1 - 2 Single-Use Vials (5mL each) every 4-6 hours. Do not exceed 12 vials in 24 hours
  • Inactive ingredients

    citric acid, glycerin, mixed berry flavor, propylene glycol, purified water, sodium benzoate, sorbitol, strawberry flavor, sucralose, tri-sodium citrate, xanthan gum

  • Other information

    • each Single-Use vial contains 16mg of sodium
    • store at 68-77ºF (20-25ºC)
    • tamper evident: do not use if top flap of carton is open. Do not use if any vials are open or broken
  • Questions or comments?

    941-202-3270 or visit www.DrKids.com

  • Package

    PDP

  • INGREDIENTS AND APPEARANCE
    CHILDRENS ALLERGY RELIEF 
    diphenhydramine hydrochloride solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:73282-0012
    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
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    TRISODIUM CITRATE DIHYDRATE (UNII: B22547B95K)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    SORBITOL (UNII: 506T60A25R)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorBERRYImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:73282-0012-120 in 1 CARTON08/06/2021
    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 DrugM01208/06/2021
    Labeler - CalmCo LLC (079308308)
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