Label: LORATADINE ALLERGY RELIEF- loratadine tablet

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

Drug Label Information

Updated December 27, 2021

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • 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 over1 tablet daily; not more than 1 tablet in 24 hours
    children under 6 years of ageask a doctor
    consumers with liver or kidney diseaseask a doctor
  • Other Information

    • store between 20° to 25° C (68° to 77° F)
    • protect from excessive moisture
    • TAMPER EVIDENT: DO NOT USE IF BLISTER UNITS ARE TORN, BROKEN OR SHOW ANY SIGNS OF TAMPERING.
  • Inactive ingredients

    corn starch, lactose monohydrate, magnesium stearate, pregelatinized starch

  • Questions?

    call 1-800-406-7984

  • SPL UNCLASSIFIED SECTION

    Distributed by:
    Ohm Laboratories Inc.
    New Brunswick, NJ 08901

  • HOW SUPPLIED

    NDC: 71335-0100-1: 20 Tablets in a BOTTLE

    NDC: 71335-0100-2: 30 Tablets in a BOTTLE

    NDC: 71335-0100-3: 60 Tablets in a BOTTLE

    NDC: 71335-0100-4: 14 Tablets in a BOTTLE

    NDC: 71335-0100-5: 10 Tablets in a BOTTLE

    NDC: 71335-0100-6: 90 Tablets in a BOTTLE

    NDC: 71335-0100-7: 28 Tablets in a BOTTLE

    NDC: 71335-0100-8: 15 Tablets in a BOTTLE

    NDC: 71335-0100-9: 100 Tablets in a BOTTLE

  • PRINCIPAL DISPLAY PANEL

    Loratadine 10mg Tablet

    Label
  • INGREDIENTS AND APPEARANCE
    LORATADINE ALLERGY RELIEF 
    loratadine tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71335-0100(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:71335-0100-120 in 1 BOTTLE; Type 0: Not a Combination Product02/12/2018
    2NDC:71335-0100-230 in 1 BOTTLE; Type 0: Not a Combination Product02/23/2018
    3NDC:71335-0100-360 in 1 BOTTLE; Type 0: Not a Combination Product12/27/2021
    4NDC:71335-0100-414 in 1 BOTTLE; Type 0: Not a Combination Product12/27/2021
    5NDC:71335-0100-510 in 1 BOTTLE; Type 0: Not a Combination Product02/20/2018
    6NDC:71335-0100-690 in 1 BOTTLE; Type 0: Not a Combination Product02/09/2018
    7NDC:71335-0100-728 in 1 BOTTLE; Type 0: Not a Combination Product12/27/2021
    8NDC:71335-0100-815 in 1 BOTTLE; Type 0: Not a Combination Product12/27/2021
    9NDC:71335-0100-9100 in 1 BOTTLE; Type 0: Not a Combination Product12/27/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA07613411/01/2017
    Labeler - Bryant Ranch Prepack (171714327)
    Registrant - Bryant Ranch Prepack (171714327)
    Establishment
    NameAddressID/FEIBusiness Operations
    Bryant Ranch Prepack171714327REPACK(71335-0100) , RELABEL(71335-0100)
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