Label: CHILDRENS ALLERGY RELIEF- diphenhydramine hcl 12.5mg/5ml solution

  • 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 July 24, 2023

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  • 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

    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)

    Do not use

    • to make a child sleepy • with any other product containing diphenhydramine, even one used on skin

  • 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- 4ct Pocuh

    Package art file

  • INGREDIENTS AND APPEARANCE
    CHILDRENS ALLERGY RELIEF 
    diphenhydramine hcl 12.5mg/5ml solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:73282-1254(NDC:70302-127)
    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
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    TRISODIUM CITRATE DIHYDRATE (UNII: B22547B95K)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    WATER (UNII: 059QF0KO0R)  
    SORBITOL (UNII: 506T60A25R)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorBERRYImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:73282-1254-14 in 1 POUCH01/01/2022
    15 mL in 1 VIAL, SINGLE-DOSE; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34101/01/2022
    Labeler - CalmCo LLC (079308308)
    Registrant - CalmCo LLC (079308308)
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