Label: LORATADINE- loratadine tablet

  • NDC Code(s): 21130-526-13, 21130-526-31, 21130-526-43, 21130-526-69
  • Packager: SAFEWAY INC.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated 03/14

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 (1-800-222-1222).

    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° to 25° C (68° to 77° F)
    • protect from excessive moisture
    • TAMPER EVIDENT: DO NOT USE IF IMPRINTED SEAL IS BROKEN OR MISSING FROM BOTTLE.
    Close
  • INACTIVE INGREDIENTS

    Corn starch, lactose monohydrate, magnesium stearate, pregelatinized starch

    Close
  • QUESTIONS OR COMMENTS?

    Call 1-888-SAFEWAY

    Close
  • PRINCIPAL DISPLAY PANEL

    NDC 21130-526-13

    Compare to Claritin®active ingredient

    Original Prescription Strength

    Non-Drowsy*

    24-Hour

    Allergy Relief

    Loratadine Tablets, USP 10mg/ Antihistamine

    INDOOR & OUTDOOR ALLERGIES

    Relief of:

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

    * When taken as directed. See Drug Facts Panel.

    120 TABLETS

    SAFEWAY®

    DISTRIBUED BY SAFEWAY INC.

    5082799/R0212

    safewaylora
    Close
  • INGREDIENTS AND APPEARANCE
    LORATADINE 
    loratadine tablet
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:21130-526
    Route of Administration ORAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    LORATADINE (UNII: 7AJO3BO7QN) (LORATADINE - UNII:7AJO3BO7QN) LORATADINE 10 mg
    Inactive Ingredients
    Ingredient Name Strength
    STARCH, CORN (UNII: O8232NY3SJ)  
    LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    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:21130-526-69 1 in 1 CARTON
    1 10 in 1 BLISTER PACK
    2 NDC:21130-526-31 3 in 1 CARTON
    2 10 in 1 BLISTER PACK
    3 NDC:21130-526-43 1 in 1 CARTON
    3 45 in 1 BOTTLE
    4 NDC:21130-526-13 1 in 1 CARTON
    4 120 in 1 BOTTLE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    ANDA ANDA076134 06/06/2009
    Labeler - SAFEWAY INC. (009137209)
    Registrant - Ranbaxy Pharmaceuticals Inc. (937890044)
    Establishment
    Name Address ID/FEI Business Operations
    Ohm Laboratories Inc. 051565745 manufacture(21130-526)
    Close