Label: LORATADINE ALLERGY RELIEF- loratadine tablet

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

Drug Label Information

Updated September 29, 2022

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

  • 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

    Repackaged and Distributed By:

    Remedy Repack, Inc.

    625 Kolter Dr. Suite #4 Indiana, PA 1-724-465-8762

  • PRINCIPAL DISPLAY PANEL

    DRUG: Loratadine Allergy Relief

    GENERIC: Loratadine

    DOSAGE: TABLET

    ADMINSTRATION: ORAL

    NDC: 70518-1399-0

    NDC: 70518-1399-1

    NDC: 70518-1399-2

    NDC: 70518-1399-3

    NDC: 70518-1399-4

    COLOR: white

    SHAPE: ROUND

    SCORE: No score

    SIZE: 6 mm

    IMPRINT: RX526

    PACKAGING: 100 in 1 BOTTLE, PLASTIC

    PACKAGING: 90 in 1 BOTTLE, PLASTIC

    PACKAGING: 20 in 1 BOTTLE, PLASTIC

    PACKAGING: 30 in 1 BLISTER PACK

    PACKAGING: 7 in 1 BLISTER PACK

    ACTIVE INGREDIENT(S):

    • LORATADINE 10mg in 1

    INACTIVE INGREDIENT(S):

    • STARCH, CORN
    • MAGNESIUM STEARATE
    • LACTOSE MONOHYDRATE

    MM2

    MM3

    MM4

    MM5

  • INGREDIENTS AND APPEARANCE
    LORATADINE ALLERGY RELIEF 
    loratadine tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70518-1399(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:70518-1399-0100 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product09/05/201809/06/2018
    2NDC:70518-1399-190 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product09/06/2018
    3NDC:70518-1399-220 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product06/07/2019
    4NDC:70518-1399-330 in 1 BLISTER PACK; Type 0: Not a Combination Product09/03/2019
    5NDC:70518-1399-47 in 1 BLISTER PACK; Type 0: Not a Combination Product09/06/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA07613409/05/2018
    Labeler - REMEDYREPACK INC. (829572556)