Label: CHILDRENS LORATADINE- loratadine tablet, chewable

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

Drug Label Information

Updated March 15, 2024

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient (in each chewable tablet)

    Loratadine USP, 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 useif you have ever had an allergic reaction to this product or any of its ingredients.

    Ask a doctor before use if you haveliver or kidney disease. Your doctor should determine if you need a different dose.

    When using this productdo not take more than directed. Taking more than directed may cause drowsiness.

    Stop use and ask a doctor ifan 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 overchew 2 tablets daily; not more than 2 chewable tablets in 24 hours
    children 2 to under 6 years of agechew 1 tablet daily; not more than 1 chewable 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 toll-free Monday to Friday 8:30 am to 5:00 pm EST at 1-800-406-7984.

  • SPL UNCLASSIFIED SECTION

    DISTRIBUTED BY
    BETTER LIVING BRANDS LLC
    P.O. BOX 99, PLEASANTON, CA
    94566-0009

  • PRINCIPAL DISPLAY PANEL - 5 mg Tablet Blister Pack Carton

    Signature
    care™
    Quality
    Guaranteed

    Compare to
    Children's Claritin ®Chewables
    active ingredient †

    NDC 21130-963-20

    24 Hour | Non-Drowsy*

    Children's Allergy Relief

    AGES 2+ YEARS

    LORATADINE CHEWABLE TABLETS USP, 5 mg Antihistamine

    GRAPE FLAVOR

    Actual Size

    • Indoor & outdoor allergies
    • Relief of: Sneezing; runny nose; itchy, watery eyes; itchy throat or nose

    *When taken as directed. See Drug Facts Panel.

    The chewable tablets are to be chewed before swallowing.

    20 CHEWABLE
    TABLETS

    20ct

  • INGREDIENTS AND APPEARANCE
    CHILDRENS LORATADINE 
    loratadine tablet, chewable
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:21130-963
    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)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MANNITOL (UNII: 3OWL53L36A)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    Product Characteristics
    Colorwhite (white to off-white) Scoreno score
    ShapeROUNDSize10mm
    FlavorGRAPEImprint Code LC5
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:21130-963-202 in 1 CARTON03/15/2024
    110 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA21008803/15/2024
    Labeler - SAFEWAY (009137209)
    Registrant - OHM LABORATORIES INC. (184769029)
    Establishment
    NameAddressID/FEIBusiness Operations
    Ohm Laboratories184769029manufacture(21130-963)
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