Label: LORATADINE- loratadine tablet

  • NDC Code(s): 53329-651-33, 53329-651-38
  • Packager: Medline Industries, Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

NOTE: Most over the counter (OTC) are not reviewed and approved by the FDA. However, they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated 03/13

If you are a consumer or patient please visit this version.

  • ACTIVE INGREDIENT (IN EACH TABLET)

    Loratadine USP, 10 mg

    Close
  • PURPOSE

    Antihistamine

    Close
  • 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
    Close
  • 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.

    Close
  • DIRECTIONS

    adults and children 6 years and over 1 tablet daily; not more than 1 tablet in 24 hours
    children under 6 years of age ask a doctor
    consumers with liver or kidney disease ask a doctor
    Close
  • 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.
    Close
  • INACTIVE INGREDIENTS

    Corn starch, lactose monohydrate, magnesium stearate, pregelatinized starch

    Close
  • QUESTIONS?

    Call 1-800-MEDLINE (633-5463), Monday - Friday, 9AM - 5PM CST

    Close
  • PRINCIPAL DISPLAY PANEL

    MEDLINE

    NDC 53329-651-33

    Compare to the active ingredient in Claritin®

    NON-DROWSY*

    LORATADINE TABLETS, USP 10 mg

    ANTIHISTAMINE

    ALLERGY RELIEF

    Indoor & Outdoor Allergies

    24 HOUR RELIEF of:

    Sneezing

    Runny Nose

    Itchy, Watery Eyes

    • Itchy Throat or Nose

    10 mg

    30 Tablets

    (When taken as directed. See Drug Facts Panel.)

    Distributed by: Medline, Industries, Inc.

    5099016/1012

    30's bottle label
    Close
  • INGREDIENTS AND APPEARANCE
    LORATADINE 
    loratadine tablet
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:53329-651
    Route of Administration ORAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    LORATADINE (LORATADINE) LORATADINE 10 mg
    Inactive Ingredients
    Ingredient Name Strength
    STARCH, CORN  
    LACTOSE MONOHYDRATE  
    MAGNESIUM STEARATE  
    STARCH, PREGELATINIZED CORN  
    Product Characteristics
    Color white (White to Off-White) Score no score
    Shape ROUND Size 6mm
    Flavor Imprint Code RX526
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:53329-651-33 30 in 1 BOTTLE
    2 NDC:53329-651-38 90 in 1 BOTTLE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    ANDA ANDA076134 08/19/2003
    Labeler - Medline Industries, Inc. (025460908)
    Registrant - Ranbaxy Pharmaceuticals Inc. (937890044)
    Establishment
    Name Address ID/FEI Business Operations
    Ohm Laboratories Inc. 051565745 manufacture(53329-651)
    Close