Label: BERKLEY AND JENSEN CHILDRENS ALLERGY RELIEF- loratadine tablet, chewable

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

Drug Label Information

Updated October 6, 2023

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  • Active ingredient (in each tablet)

    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

    •
    chew or crush tablets completely before swallowing

    adults and children 6 years and over

    chew 2 tablets daily; not more than 2 tablets in 24 hours

    children 2 to under 6 years of age

    chew 1 tablet daily; not more than 1 tablet in 24 hours

    children under 2 years of age

    ask a doctor

    consumers with liver or kidney disease

    ask a doctor
  • Other information

    •
    phenylketonurics: contains phenylalanine 1.4 mg per tablet
    •
    do not use if blister unit is broken or torn
    •
    store between 20° to 25°C (68° to 77°F)
  • Inactive ingredients

    artificial grape flavor, aspartame, colloidal silicon dioxide, D&C red #27 aluminum lake, FD&C blue #2 aluminum lake, magnesium stearate, mannitol, microcrystalline cellulose, sodium starch glycolate, stearic acid

  • Questions or comments?

    1-800-934-1204

  • Principal Display Panel

    Compare to the Active Ingredient in Children’s Claritin® Chewables

    berkley jensen®

    2 YEARS AND OLDER

    children’s

    NON-DROWSY*

    ALLERGY RELIEF

    LORATADINE CHEWABLE TABLETS, 5 mg

    ANTIHISTAMINE

    INDOOR & OUTDOOR ALLERGIES

    24 HOUR RELIEF OF:

    • SNEEZING

    • RUNNY NOSE

    • ITCHY, WATERY EYES

    • ITCHY THROAT OR NOSE

    40 CHEWABLE TABLETS

    GRAPE FLAVOR

    *When taken as directed. See Drug Facts Panel.

    ACTUAL SIZE

    3y8-d3-allergy-relief
  • INGREDIENTS AND APPEARANCE
    BERKLEY AND JENSEN CHILDRENS ALLERGY RELIEF 
    loratadine tablet, chewable
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68391-301
    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)  
    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)  
    Product Characteristics
    ColorPURPLE (light) Scoreno score
    ShapeROUNDSize8mm
    FlavorGRAPEImprint Code L3Y8
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:68391-301-4940 in 1 CARTON01/25/2022
    11 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA21003301/25/2022
    Labeler - BJWC (159082692)
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