Label: CHILDRENS ALLERGY RELIEF DYE FREE CHERRY- diphenhydramine hcl liquid

  • 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 December 9, 2019

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  • Active ingredient (in each 5 mL tsp)

    Diphenhydramine HCl 12.5 mg

  • Purpose

    Antihistamine

  • KEEP OUT OF REACH OF CHILDREN

  • 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 you have

    • glaucoma
    • a breathing problem such as emphysema or chronic bronchitis
    • difficulty in urination due to an enlarged prostate gland

    Ask a doctor or pharmacist before use if you are

    taking sedatives or tranquilizers

    When using this product
    • avoid alcoholic drinks
    • alcohol, sedatives, and tranquilizers may increase drowsiness
    • marked drowsiness may occur
    • excitability may occur especially in children
    • be careful when driving a motor vehicle or operating machinery

    If pregnant or breast feeding,

    ask a health professional before use.

    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
     Age (yr)Dose (mL or tsp) 
     children under 2 years do not use
     children under 6 years ask a doctor
     children 6 to under 12 years 1 to 2 tsp (5 mL to 10 mL)
     adults and children 12 years and above 2 to 4 tsp (10 mL to 20 mL)

  • Other information

    • each tsp contains: sodium 5 mg
    • dosing cup provided
    • store at 68o - 77oF
  • Inactive ingredients

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

  • Questions?

    1-800-824-1706 Monday -Friday 9am - 4pm MST.

    You may also report side effects to this phone number

  • PDP

    *Compare to the active ingredient in Children's BENADRYL Dye Free Allergy Liquid

    WinCo Foods

    Children's Allery Relief

    Diphenhydramine HCl 12.5 mg/Antihistamine

    Relieves: Sneezing, Runny Nose, Itchy, Watery Eyes & Itchy Throat

    Dye Free

    Cherry Flavor

    4 fl oz (118 mL)

    Box

  • INGREDIENTS AND APPEARANCE
    CHILDRENS ALLERGY RELIEF DYE FREE CHERRY 
    diphenhydramine hcl liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:67091-219
    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 (UNII: SB8ZUX40TY)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    SORBITOL (UNII: 506T60A25R)  
    Product Characteristics
    ColorwhiteScore    
    ShapeSize
    FlavorCHERRYImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:67091-219-181 in 1 CARTON12/12/2014
    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 finalpart34112/12/2014
    Labeler - WinCo Foods, LLC (056098817)
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