Label: CHILDRENS ALLERGY RELIEF- antihistamine 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 October 27, 2014

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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 adoctor 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

  • PDP

    Sunmark

    Compare to childrens benadyl active ingredient

    Children's allergy relief dye-free

    antihistamine

    Relieves sneezing, runny nose, itchy, watery eyes, itchy throat

    Diphenhydramine HCl

    antihistamine

    Bubblegum Flavor

    4 fl oz (118mL)

    SN

  • INGREDIENTS AND APPEARANCE
    CHILDRENS ALLERGY RELIEF 
    antihistamine liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49348-056
    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
    Colorwhite (clear) Score    
    ShapeSize
    FlavorBUBBLE GUMImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:49348-056-341 in 1 CARTON
    1118 mL in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34108/08/2013
    Labeler - Mckesson (177667227)
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