Label: CHILDRENS LORATADINE SUGAR FREE- loratadine solution

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

Drug Label Information

Updated December 15, 2017

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • 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:

    • runny nose
    • itchy, watery eyes
    • sneezing
    • 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 age1 teaspoonful (tsp) daily; do not take more than 1 teaspoonful (tsp) in 24 hours
    children under 2 years of ageask a doctor
    consumers with liver or kidney diseaseask a doctor
  • Other information

    • do not use if bottle wrap imprinted with "SEALED FOR SAFETY" is broken or missing.
    • see bottom panel for lot number and expiration date
    • store between 20° and 25°C (68° and 77°F)
  • Inactive ingredients

    butylated hydroxyanisole, glycerin, grape flavor, maltitol solution, masking agent, phosphoric acid, polyethylene glycol, propylene glycol, purified water, sodium benzoate, sodium phosphate monobasic dihydrate, sorbitol solution, sucralose powder.

  • Questions?

    Call 1-866-923-4914

  • PRINCIPAL DISPLAY PANEL - 120 mL Bottle Carton

    RITE
    AID    ®
    PHARMACY

    *Compare to the
    active ingredient in
    Children's Claritin®

    ORIGINAL
    PRESCRIPTION
    STRENGTH

    children's
    allergy

    loratadine oral solution
    USP, 5 mg/5 mL

    (antihistamine)
    allergy

    NON-DROWSY†

    24 hour
    relief of:
    sneezing
    runny nose
    itchy, watery eyes
    itchy throat or nose

    grape
    flavor

    dosing cup
    enclosed

    ages 2 years and older
    INDOOR & OUTDOOR ALLERGIES

    4 FL OZ (120 mL)
    † When taken as directed. See Drug Facts Panel.

    Principal Display Panel - 120 mL Bottle Carton
  • INGREDIENTS AND APPEARANCE
    CHILDRENS LORATADINE   SUGAR FREE
    loratadine solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11822-2131
    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
    butylated hydroxyanisole (UNII: REK4960K2U)  
    glycerin (UNII: PDC6A3C0OX)  
    sorbitol (UNII: 506T60A25R)  
    polyethylene glycol, unspecified (UNII: 3WJQ0SDW1A)  
    phosphoric acid (UNII: E4GA8884NN)  
    propylene glycol (UNII: 6DC9Q167V3)  
    water (UNII: 059QF0KO0R)  
    sodium benzoate (UNII: OJ245FE5EU)  
    sodium phosphate, monobasic, dihydrate (UNII: 5QWK665956)  
    Product Characteristics
    ColorYELLOW (colorless to slightly yellow) Score    
    ShapeSize
    FlavorGRAPEImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:11822-2131-81 in 1 CARTON10/17/2017
    1120 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA07680503/17/2017
    Labeler - Rite Aid Corporation (014578892)
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