Label: ALLERGY CHILDRENS- diphenhydramine hydrochloride 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 August 16, 2016

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  • Active ingredient (in each 5 mL)*

    Diphenhydramine HCl 12.5 mg

    *5 mL = 1 teaspoon (tsp)

  • 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
    • temporarily relieves these symptoms due to common cold:
    • runny nose
    • sneezing
  • Warnings

    Do not use

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

    Ask a doctor before use if you have

    • glaucoma
    • trouble urinating due to an enlarged prostate gland
    • a breathing problem such as emphysema or chronic bronchitis
    • a sodium-restricted diet

    Ask a doctor or pharmacist before use if you are

    taking sedatives or tranquilizers

    When using this product

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

    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. (1-800-222-1222)

  • Directions

    • take every 4 - 6 hours
    • do not take more than 6 times in 24 hours

    Age (yr)

    Dose

    Adult and children 12

    years of age and over

    10-20 mL

    (25 to 50 mg)

    Children 6 to under

    12 years of age

    5-10 mL

    (12.5 to 25 mg)

    Children under 6 years

    of age

    Ask a doctor

  • Other information

    • store at room temperature 15-30°C (59-86°F)
    • protect from freezing
    • protect from light
    • each teaspoon (5 mL) contains: sodium 16 mg
  • Inactive ingredients

    citric acid, D&C red #33, FD&C red #40, flavor, glycerin, high fructose corn syrup, poloxamer 407, purified water, sodium benzoate, sodium chloride, sodium citrate, sodium sacchrin, sorbitol, sucrose

  • Questions or comments?

    1-888-705-WECARE (Mon-Fri 9am-5pm EST) or www.wecaredistributor.com

  • Principal Display Panel

    Compare to the active ingredient in Children’s Benadryl® Allergy Liquid

    See New Warnings and Directions

    CHILDREN'S ALLERGY

    LIQUID MEDICATION

    DIPHENHYDRAMINE HCl

    ORAL SOLUTION

    ANTIHISTAMINE

    Relieves: Sneezing, Runny nose, Itchy, watery eyes, Itchy throat

    Cherry Flavored

    Alcohol Free

    Allergy Carton Image 1

  • INGREDIENTS AND APPEARANCE
    ALLERGY  CHILDRENS
    diphenhydramine hydrochloride liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70005-036
    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
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    HIGH FRUCTOSE CORN SYRUP (UNII: XY6UN3QB6S)  
    POLOXAMER 407 (UNII: TUF2IVW3M2)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    SODIUM CITRATE (UNII: 1Q73Q2JULR)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    SUCROSE (UNII: C151H8M554)  
    SORBITOL (UNII: 506T60A25R)  
    Product Characteristics
    ColorRED (Bluish-Red) Score    
    ShapeSize
    FlavorCHERRYImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70005-036-011 in 1 CARTON06/21/2016
    1120 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34106/21/2016
    Labeler - We Care Distributors Inc. (079832998)
    Establishment
    NameAddressID/FEIBusiness Operations
    Purine Pharma019950491manufacture(70005-036)
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