Label: LORATADINE ODT- loratadine tablet, orally disintegrating

  • NDC Code(s): 21130-527-31, 21130-527-69
  • Packager: Safeway 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 09/12

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

    • place 1 tablet on tongue; tablet disintegrates, with or without water
      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

    • Phenylketonurics: Contains Phenylalanine 0.6 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). Protect from excessive moisture.
    • keep in a dry place.
    • use tablet immediately after opening individual blister.
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  • INACTIVE INGREDIENTS

    Aspartame, croscarmellose sodium, fruit flavors, magnesium stearate, mannitol, sodium stearyl fumarate

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  • QUESTIONS OR COMMENTS?

    Call 1-888-SAFEWAY

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  • PRINCIPAL DISPLAY PANEL

    NDC 21130-527-69

    Compare to Claritin®RediTabs®active ingredient

    Original Prescription Strength

    Non-Drowsy*

    24-Hour Allergy Relief

    Loratadine Orally Disintegrating Tablets, 10 mg

    Antihistamine

    Indoor & Outdoor Allergies

    • No Water Needed
    • Melts in Your Mouth

    Relief of:

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

    For Adults and Children Six Years and Older

    *When taken as directed.

    See Drug Facts Panel.

    10 ORALLY DISINTEGRATING TABLETS

    SAFEWAY

    DISTRIBUTED BY SAFEWAY INC.

    5082800/R0212

    This is the 10 count blister carton label for Safeway Loratadine ODT.

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  • INGREDIENTS AND APPEARANCE
    LORATADINE ODT 
    loratadine tablet, orally disintegrating
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:21130-527
    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
    ASPARTAME  
    CROSCARMELLOSE SODIUM  
    MAGNESIUM STEARATE  
    MANNITOL  
    SODIUM STEARYL FUMARATE  
    Product Characteristics
    Color white (White to Off-White) Score no score
    Shape ROUND (flat faced beveled edge) Size 10mm
    Flavor FRUIT Imprint Code RC17
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:21130-527-69 10 in 1 BLISTER PACK
    2 NDC:21130-527-31 30 in 1 BLISTER PACK
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    ANDA ANDA077153 08/31/2007
    Labeler - Safeway Inc. (009137209)
    Registrant - Ranbaxy Pharmaceuticals Inc. (937890044)
    Establishment
    Name Address ID/FEI Business Operations
    Ohm Laboratories Inc. 051565745 manufacture(21130-527)
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