Label: LORATADINE tablet

  • NDC Code(s): 68016-526-31, 68016-526-60, 68016-526-69, 68016-526-90
  • Packager: Premier Value
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated January 11, 2018

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  • ACTIVE INGREDIENT (IN EACH TABLET)

    Loratadine USP, 10 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.

  • DIRECTIONS

    adults and children 6 years and over1 tablet daily; not more than 1 tablet in 24 hours
    children under 6 years of ageask a doctor
    consumers with liver or kidney diseaseask a doctor
  • OTHER INFORMATION

    • store between 20 and 25° C (68 and 77° F)
    • protect from excessive moisture
    • TAMPER EVIDENT: DO NOT USE IF BLISTER UNITS ARE TORN, BROKEN OR SHOW ANY SIGNS OF TAMPERING.
    • TAMPER EVIDENT: DO NOT USE IF IMPRINTED SEAL IS BROKEN OR MISSING FROM BOTTLE.
  • INACTIVE INGREDIENTS

    corn starch, lactose monohydrate, magnesium stearate, pregelatinized starch

  • QUESTIONS?

    call 1-800-406-7984

    Keep the carton. It contains important information.

    See end panel for expiration date.

    DISTRIBUTED BY

    CHAIN DRUG CONSORTIUM

    3301 NW BOCA RATON BLVD

    SUITE 101, BOCA RATON, FL 33431

  • PRINCIPAL DISPLAY PANEL - 10 mg Tablet Blister Pack Carton

    Premier
    Value®

    COMPARE TO THE ACTIVE
    INGREDIENT OF CLARITIN®†

    Original Prescription Strength
    NON-DROWSY*

    24 Hour Allergy Relief

    Loratadine Tablets, USP 10 mg

    Allergy Relief

    Indoor & Outdoor
    Allergies

    Antihistamine

    Relief of:

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

    10 Tablets

    *When taken as directed. See Drug Facts Panel.

    INDEPENDENTLY TESTED
    PV
    SATISFACTION GUARANTEED

    PRINCIPAL DISPLAY PANEL - 10 mg Tablet Blister Pack Carton
  • INGREDIENTS AND APPEARANCE
    LORATADINE 
    loratadine tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68016-526
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    LORATADINE (UNII: 7AJO3BO7QN) (LORATADINE - UNII:7AJO3BO7QN) LORATADINE10 mg
    Inactive Ingredients
    Ingredient NameStrength
    STARCH, CORN (UNII: O8232NY3SJ)  
    LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    Product Characteristics
    Colorwhite (white to off-white) Scoreno score
    ShapeROUNDSize6mm
    FlavorImprint Code RX526
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:68016-526-6910 in 1 BLISTER PACK; Type 0: Not a Combination Product08/19/2003
    2NDC:68016-526-3130 in 1 BLISTER PACK; Type 0: Not a Combination Product08/19/2003
    3NDC:68016-526-6060 in 1 BOTTLE; Type 0: Not a Combination Product08/19/2003
    4NDC:68016-526-9090 in 1 BOTTLE; Type 0: Not a Combination Product08/19/2003
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA07613408/19/2003
    Labeler - Premier Value (101668460)
    Registrant - Ranbaxy Pharmaceuticals Inc. (937890044)
    Establishment
    NameAddressID/FEIBusiness Operations
    Ohm Laboratories Inc.051565745manufacture(68016-526)
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