Label: CHILDRENS ALLERGY RELIEF DYE FREE- diphenhydramine hcl liquid

  • NDC Code(s): 70000-0693-1
  • Packager: CARDINAL HEALTH 110, LLC. DBA LEADER
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated October 21, 2024

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  • ACTIVE INGREDIENT(S)

    Diphenhydramine HCl 12.5 mg

  • PURPOSE

    Antihistamine

  • USE(S)

    • temporarily relieves these symptoms due to hay fever or other upper respiratory allergies :
    • runny nose
    • itchy, watery eyes 
    • sneezing 
    • 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

    • glaucoma 
    • a breathing problem such as emphysema or chronic bronchitis
    • a sodium restricted diet 
  • ASK A DOCTOR OR PHARMACIST BEFORE USE IF THE CHILD IS

    taking sedatives or tranquilizers.

  • WHEN USING THIS PRODUCT

    • alcohol, sedatives, and tranquilizers may increase drowsiness 
    • marked drowsiness may occur
    • 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.

  • DIRECTIONS

    • take every 4 to 6 hours 
    • do not take more than 6 doses in 24 hours 
    • use only enclosed dosing cup specifically designed for use with this product. Do not use any other dosing device


    AGE(yr)DOSE(mL or tsp) 
     children under 2 years  do not use
     children 2 to under 6 years  ask a doctor
     children 6 to under 12 years  1 to 2 tsp (5 mL to 10 mL)
  • OTHER INFORMATION

    • each tsp contains: sodium 5 mg 
    • store at 68o -77o F
  • INACTIVE INGRADIENTS

    carboxymethylcellulose sodium, citric acid, flavors, glycerin, purified water, saccharin sodium, sodium benzoate, sorbitol.

  • QUESTIONS OR COMMENTS?

    (609) 860-2600

  • PRINCIPAL DISPLAY PANEL

    NDC 70000-0693-1

    DYE-FREE

    Children's Allergy Relief 

    Diphenhydramine HCl

    12.5mg /5 mL Oral Solution 

    Antihistamine

    Cherry

    Flavored Liquid

    4-6 hours/Dose

    Relief of:

    Sneezing 

    Runny Nose 

    itchy, water eyes

    itchy Throat

    or Nose

    Alcohol -Free

    100% Money Back Guarantee

    8 FL OZ (236 mL)

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  • INGREDIENTS AND APPEARANCE
    CHILDRENS ALLERGY RELIEF DYE FREE 
    diphenhydramine hcl liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70000-0693
    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
    CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)  
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    WATER (UNII: 059QF0KO0R)  
    SACCHARIN SODIUM ANHYDROUS (UNII: I4807BK602)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    SORBITOL (UNII: 506T60A25R)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorCHERRYImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70000-0693-11 in 1 CARTON09/13/2024
    1236 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01209/13/2024
    Labeler - CARDINAL HEALTH 110, LLC. DBA LEADER (063997360)
    Establishment
    NameAddressID/FEIBusiness Operations
    Guardian Drug Company119210276MANUFACTURE(70000-0693)
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