Label: LORATADINE- loratadine tablet

  • NDC Code(s): 21130-526-13, 21130-526-31, 21130-526-38, 21130-526-43, view more
    21130-526-69
  • Packager: SAFEWAY INC.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated March 11, 2015

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

  • ACTIVE INGREDIENT (IN EACH TABLET)

    Loratadine, USP 10 mg

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  • PURPOSE

    Antihistamine

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  • 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
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  • 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).

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  • 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

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  • 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.
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  • INACTIVE INGREDIENTS

    Corn starch, lactose monohydrate, magnesium stearate, pregelatinized starch

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  • QUESTIONS OR COMMENTS?

    Call 1-888-732-3929

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  • PRINCIPAL DISPLAY PANEL

    NDC 21130-526-38

    Compare to Claritin®active ingredient

    24-HOURORIGINAL PRESCRIPTION STRENGTH

    Allergy Relief

    Loratadine Tablets, USP 10mg

    Antihistamine

    Non-Drowsy*
    Relief of:

    Sneezing, runny Nose, itchy, watery eyes; itchy throat or nose

    * When taken as directed. See Drug Facts Panel.

    365 TABLETS VALUE PACK

    SAFEWAY®

    DISTRIBUED BY SAFEWAY INC.

    5115097/0115

    safewaylora
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  • INGREDIENTS AND APPEARANCE
    LORATADINE 
    loratadine tablet
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:21130-526
    Route of Administration ORAL
    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; Type 0: Not a Combination Product
    2 NDC:21130-526-31 3 in 1 CARTON
    2 10 in 1 BLISTER PACK; Type 0: Not a Combination Product
    3 NDC:21130-526-43 1 in 1 CARTON
    3 45 in 1 BOTTLE; Type 0: Not a Combination Product
    4 NDC:21130-526-13 1 in 1 CARTON
    4 120 in 1 BOTTLE; Type 0: Not a Combination Product
    5 NDC:21130-526-38 1 in 1 CARTON
    5 365 in 1 BOTTLE; Type 0: Not a Combination Product
    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)
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