Label: ALLERGY CHILDRENS- loratadine liquid

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated November 1, 2022

If you are a consumer or patient please visit this version.

  • Active ingredient (in each 5 mL teaspoonful)

    Loratadine 5 mg

  • Purpose

    Antihistamine

  • Uses

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


  • Warnings

    Do not use

    if you have ever had an allergic reaction to this product or any of its ingredients

    Ask a doctor before use if you have

    liver or kidney disease. Your doctor should determine if you need a different dose

    When using this product,

    do not take more than directed. Taking more than directed may cause drowsiness.

    Stop use and ask a doctor if

    an allergic reaction to this product occurs. Seek medical help right away.

    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

    • use only with enclosed dosing cup
    adults and children 6 years and over2 teaspoonfuls (tsp) daily; do not take more than 2 teaspoonfuls (tsp) in 24 hours   
    children 2 to under 6 years of age 1 teaspoonful (tsp) daily; do not take more than 1 teaspoonful (tsp) in 24 hours 
    children under 2 years of age  ask a doctor
    consumers with liver or kidney disease  ask a doctor

  • Other information

    • each teaspoonful contains: sodium 1 mg
    • store between 20º to 25ºC (68º to 77ºF)
  • Inactive ingredients

    butylated hydroxyanisole, citric acid, glycerin, grape flavor, propylene glycol, purified water, sodium benzoate, sucralose

  • Questions or Comments?

    Call 1-877-753-3935 Monday-Friday 9AM-5PM EST 

  • Principal Display Panel

    Compare to Children's Claritin® Allergy active ingredient†

    CHILDREN'S

    Allergy

    Loratadine Oral Solution 5 mg | 5mL

    Antihistamine

    24 HOUR RELIEF OF

    Indoor & Outdoor Allergies

    Sneezing, Runny Nose,

    Itchy, Watery Eyes,

    Itchy Throat or Nose

    For ages 2 Years and over

    Non-drowsy*

    Dye free

    Alcohol free

    Sugar-Free

    Grape Flavor

    *When taken as directed See Drug Facts panel.

    FL OZ (mL)

    †This product is not manufactured or distributed by Bayer HealthCare LLC, distributor of Children's Claritin® Allergy.

    TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL AROUND BOTTLE IS BROKEN OR MISSING.

    DIST. BY MEIJER DISTRIBUTION, INC.

    GRAND RAPIDS, MI 49544

    www.meijer.com

  • Product Label

    Loratadine 5 mg

    MEIJER Children's Allergy Grape Flavor

  • INGREDIENTS AND APPEARANCE
    ALLERGY  CHILDRENS
    loratadine liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:41250-539
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    LORATADINE (UNII: 7AJO3BO7QN) (LORATADINE - UNII:7AJO3BO7QN) LORATADINE5 mg  in 5 mL
    Inactive Ingredients
    Ingredient NameStrength
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    BUTYLATED HYDROXYANISOLE (UNII: REK4960K2U)  
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorGRAPEImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:41250-539-041 in 1 BOX02/28/201802/28/2025
    1120 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA07742102/28/201802/28/2025
    Labeler - MEIJER, INC. (006959555)