Label: 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 December 21, 2021

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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 (1-800-222-1222).

  • 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
  • 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.
  • INACTIVE INGREDIENTS

    Corn starch, lactose monohydrate, magnesium stearate, pregelatinized starch

  • QUESTIONS OR COMMENTS?

    Call 1-888-732-3929

  • PRINCIPAL DISPLAY PANEL - 10 mg Tablet Bottle Carton

    NDC 21130-526-38

    Signature
    care™
    Quality Guaranteed

    24 HOUR | ORIGINAL PRESCRIPTION STRENGTH

    Allergy Relief

    Loratadine Tablets, USP 10 mg
    Antihistamine

    Compare to
    Claritin®
    active ingredient†

    •
    Non-drowsy*
    •
    Relief of:
    Sneezing; runny nose;
    itchy, watery eyes;
    itchy throat or nose

    *When taken as directed. See Drug Facts Panel.

    Actual Size

    365 TABLETS

    VALUE PACK

    PRINCIPAL DISPLAY PANEL - 10 mg Tablet Bottle Carton
  • INGREDIENTS AND APPEARANCE
    LORATADINE 
    loratadine tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:21130-526
    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:21130-526-691 in 1 CARTON06/06/2009
    110 in 1 BLISTER PACK; Type 0: Not a Combination Product
    2NDC:21130-526-313 in 1 CARTON06/06/2009
    210 in 1 BLISTER PACK; Type 0: Not a Combination Product
    3NDC:21130-526-431 in 1 CARTON06/06/2009
    345 in 1 BOTTLE; Type 0: Not a Combination Product
    4NDC:21130-526-131 in 1 CARTON06/06/2009
    4120 in 1 BOTTLE; Type 0: Not a Combination Product
    5NDC:21130-526-381 in 1 CARTON06/06/2009
    5365 in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA07613406/06/2009
    Labeler - SAFEWAY INC. (009137209)
    Establishment
    NameAddressID/FEIBusiness Operations
    Ohm Laboratories Inc.051565745MANUFACTURE(21130-526)
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