Label: CHILDREN ALLERGY RELIEF DYE FREE CHERRY- diphenhydramine hcl solution

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

Drug Label Information

Updated November 1, 2023

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  • ACTIVE INGREDIENT(in each 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 
    • 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 chronic bronchitis

  • ASK A DOCTOR OR PHARMACIST BEFORE USE IF THE CHILD IS

    taking sedatives or tranquilizers

  • WHEN USING THIS PRODUCT

    • 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

    (1-800-222-1222).

  • DIRECTIONS

    • find right dose on chart below
    • mL=milliliter
    • measure only with dosing cup provided
    • do not use dosing cup with other products
    • take every 4 to 6 hours, or as directed by a doctor
    • do not take more than 6 doses in 24 hours

    AGE(yr) DOSE(mL)
    children under  2 years  do not use
    children 2 to 5 years do not use unless directed by a doctor
    children 6 to 11 years 5 mL to 10 mL
  • OTHER INFORMATION

    • each 5 mL contains: sodium 5 mg
    • dosing cup provided 
    • store between 20 - 25oC (68o- 77oF)
  • INACTIVE INGREDIENTS

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

  • QUESTIONS OR COMMENTS?

    Call 833-358-6431 Monday to Friday 9:00 am to 7:00 pm EST

  • HOW SUPPLIED

    Product: 50090-6163

    NDC: 50090-6163-0 118 mL in a BOTTLE / 1 in a CARTON

  • CHILDREN ALLERGY RELIEF DYE FREE

    Label Image
  • INGREDIENTS AND APPEARANCE
    CHILDREN ALLERGY RELIEF DYE FREE CHERRY 
    diphenhydramine hcl solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50090-6163(NDC:70677-0144)
    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, UNSPECIFIED FORM (UNII: K679OBS311)  
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    glycerin (UNII: PDC6A3C0OX)  
    water (UNII: 059QF0KO0R)  
    sodium benzoate (UNII: OJ245FE5EU)  
    sorbitol (UNII: 506T60A25R)  
    SACCHARIN SODIUM ANHYDROUS (UNII: I4807BK602)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorCHERRYImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:50090-6163-01 in 1 CARTON10/11/2022
    1118 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01204/22/2022
    Labeler - A-S Medication Solutions (830016429)
    Establishment
    NameAddressID/FEIBusiness Operations
    A-S Medication Solutions830016429RELABEL(50090-6163)
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