Label: CHILDRENS LORATADINE- loratadine tablet, chewable

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

Drug Label Information

Updated August 7, 2018

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient (in each tablet)

    Loratadine USP, 5 mg

  • 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
  • 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

    adults and children 6 years and overchew 2 tablets daily; not more than 2 tablets in 24 hours
    children 2 to under 6 years of agechew 1 tablet daily; not more than 1 tablet in 24 hours
    children under 2 years of ageask a doctor
    consumers with liver or kidney diseaseask a doctor
  • Other information

    • phenylketonurics: contains phenylalanine 1.25 mg per tablet.
    • TAMPER EVIDENT: DO NOT USE IF BLISTER UNITS ARE TORN, BROKEN OR SHOW ANY SIGNS OF TAMPERING.
    • store between 20° to 25°C (68° to 77°F).
  • Inactive ingredients

    aspartame, citric acid anhydrous, colloidal silicon dioxide, D&C red No. 27 aluminum lake, FD&C blue No. 2 aluminum lake, flavor, magnesium stearate, mannitol, microcrystalline cellulose, sodium starch glycolate, stearic acid

  • Questions?

    call 1-800-406-7984

  • SPL UNCLASSIFIED SECTION

    Distributed By AmerisourceBergen
    1300 Morris Drive, Chesterbrook, PA 19087

  • PRINCIPAL DISPLAY PANEL - 5 mg Tablet Blister Pack Carton

    GOOD
    NEIGHBOR
    PHARMACY®

    Compare to Children's Claritin®
    Chewables active ingredient**

    NDC 46122-550-60

    ages 2 years and older

    Non-Drowsy*
    24 HOUR

    Children's
    loratadine chewable tablets USP, 5 mg
    antihistamine

    Indoor & Outdoor Allergies

    Relief of:

    • Sneezing   • Runny Nose   • Itchy, Watery Eyes   • Itchy Throat or Nose

    20 Chewable Tablets
    The chewable tablets are to be chewed before swallowing.
    *When taken as directed. See Drug Facts Panel.

    actual size
    grape flavor

    PRINCIPAL DISPLAY PANEL - 5 mg Tablet Blister Pack Carton
  • INGREDIENTS AND APPEARANCE
    CHILDRENS LORATADINE 
    loratadine tablet, chewable
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:46122-550
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Loratadine (UNII: 7AJO3BO7QN) (Loratadine - UNII:7AJO3BO7QN) Loratadine5 mg
    Inactive Ingredients
    Ingredient NameStrength
    aspartame (UNII: Z0H242BBR1)  
    anhydrous citric acid (UNII: XF417D3PSL)  
    silicon dioxide (UNII: ETJ7Z6XBU4)  
    d&c red no. 27 (UNII: 2LRS185U6K)  
    fd&c blue no. 2 (UNII: L06K8R7DQK)  
    magnesium stearate (UNII: 70097M6I30)  
    mannitol (UNII: 3OWL53L36A)  
    microcrystalline cellulose (UNII: OP1R32D61U)  
    stearic acid (UNII: 4ELV7Z65AP)  
    sodium starch glycolate type a potato (UNII: 5856J3G2A2)  
    Product Characteristics
    ColorPURPLE (light purple to dark purple) Scoreno score
    ShapeROUNDSize10mm
    FlavorGRAPEImprint Code 753
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:46122-550-602 in 1 CARTON07/01/2018
    110 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA21008807/01/2018
    Labeler - Amerisource Bergen (007914906)
    Establishment
    NameAddressID/FEIBusiness Operations
    Ohm Laboratories Inc.184769029MANUFACTURE(46122-550)
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