Label: CHILDRENS LORATADINE- loratadine tablet, chewable

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

Drug Label Information

Updated July 17, 2019

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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

    •
    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 1.25 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, carmine, citric acid anhydrous, colloidal silicon dioxide, 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.

    Keep the carton. It contains important information. See end panel for expiration date.

  • SPL UNCLASSIFIED SECTION

    Distributed by:
    Ohm Laboratories Inc.
    New Brunswick, NJ 08901

    0619

  • PRINCIPAL DISPLAY PANEL - 5 mg Tablet Blister Pack Carton

    NDC 51660-754-31

    †Compare to the active ingredient of Children's Claritin®Chewable

    ages 2 years and older

    Children's

    Loratadine Chewable Tablets USP, 5 mg

    Antihistamine

    Indoor & Outdoor Allergies

    30 CHEWABLE TABLETS

    The chewable tablets are to be chewed before swallowing.

    Bubble Gum Flavored

    Non-Drowsy*

    24 Hour Relief of:

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

    *When taken as directed. See Drug Facts Panel.

    †Ohm® is a registered trademark of Sun Pharmaceutical Industries, Inc. All other trademarks are property of their respective owners.

    Carton label
  • INGREDIENTS AND APPEARANCE
    CHILDRENS LORATADINE 
    loratadine tablet, chewable
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51660-754
    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)  
    COCHINEAL (UNII: TZ8Z31B35M)  
    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
    ColorPINK (light to medium pink with a slightly speckled appearance) Scoreno score
    ShapeROUND (Flat face, bevelled edge) Size10mm
    FlavorBUBBLE GUMImprint Code 754
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:51660-754-313 in 1 CARTON06/30/2018
    110 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA21008806/30/2018
    Labeler - Ohm Laboratories Inc. (184769029)
    Establishment
    NameAddressID/FEIBusiness Operations
    Ohm Laboratories Inc.184769029MANUFACTURE(51660-754)
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