Label: LORATADINE ALLERGY RELIEF- loratadine tablet

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated November 1, 2022

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  • ACTIVE INGREDIENT(S)

    Loratadine USP, 10 mg

  • PURPOSE

    Antihistamine

  • USE(S)

    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.

  • 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 and kidney disease

    ask a doctor
  • OTHER INFORMATION

    •
    store between 20 and 25° C (68 and 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?

    Call 1-800-406-7984

  • PRINCIPAL DISPLAY PANEL

    NDC 63187-100-10

    †Compare to the active ingredient of Claritin®

    NON-DROWSY*

    24 HourAllergy Relief

    Loratadine Tablets USP, 10 mg

    Antihistamine

    Indoor & Outdoor Allergies

    Relief of:

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

    10 Tablets

    When taken as directed. See Drug Facts Panel.

    Manufactured by: Ohm Laboratories Inc.

    5069178/0908

    Repackaged by:

    Proficient Rx LP

    Thousand Oaks, CA 91320

    63187-100-10
  • INGREDIENTS AND APPEARANCE
    LORATADINE ALLERGY RELIEF 
    loratadine tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63187-100(NDC:51660-526)
    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:63187-100-1010 in 1 BOTTLE; Type 0: Not a Combination Product01/01/2019
    2NDC:63187-100-2020 in 1 BOTTLE; Type 0: Not a Combination Product01/01/2019
    3NDC:63187-100-3030 in 1 BOTTLE; Type 0: Not a Combination Product01/01/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA07613408/28/2003
    Labeler - Proficient Rx LP (079196022)
    Establishment
    NameAddressID/FEIBusiness Operations
    Proficient Rx LP079196022REPACK(63187-100) , RELABEL(63187-100)
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