Label: ALLERGY RELIEF- loratadine tablet

  • NDC Code(s): 69168-414-02, 69168-414-03, 69168-414-08, 69168-414-09, view more
    69168-414-17, 69168-414-30, 69168-414-60
  • Packager: Allegiant Health
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated June 16, 2020

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  • Active ingredient (in each tablet)

    Loratadine 10mg

  • 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.

    You may report side effects to 1-888-952-0050.

    Pregnancy/Breastfeeding

    ask a health professional before use.

    Keep out of reach of children

    In case of accidental overdose, contact a doctor or Poison Control Center (1-800-222-1222) 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 or kidney disease: ask a doctor

  • Other information

    • store between 20° to 25°C (68° to 77°F)
    • protect from excessive moisture
    • do not use if imprinted seal under safety cap is broken or missing
  • Inactive ingredients


    lactose monohydrate, magnesium stearate, sodium starch glycolate
    May contain: microcrystalline cellulose, pregelatinized starch

  • Principal Display Panel

    Loratadine

    Loratadine

  • INGREDIENTS AND APPEARANCE
    ALLERGY RELIEF 
    loratadine tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69168-414
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    LORATADINE (UNII: 7AJO3BO7QN) (LORATADINE - UNII:7AJO3BO7QN) LORATADINE10 mg
    Inactive Ingredients
    Ingredient NameStrength
    LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    SODIUM STARCH GLYCOLATE TYPE A (UNII: H8AV0SQX4D)  
    Other Ingredients
    Ingredient KindIngredient NameQuantity
    May containMICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    May containSTARCH, CORN (UNII: O8232NY3SJ)  
    Product Characteristics
    ColorwhiteScoreno score
    ShapeROUNDSize6mm
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69168-414-17300 in 1 BOTTLE; Type 0: Not a Combination Product05/01/2020
    2NDC:69168-414-033 in 1 CARTON05/01/2020
    210 in 1 BLISTER PACK; Type 0: Not a Combination Product
    3NDC:69168-414-6060 in 1 BOTTLE; Type 0: Not a Combination Product05/18/2022
    4NDC:69168-414-3030 in 1 BOTTLE; Type 0: Not a Combination Product05/01/2020
    5NDC:69168-414-0910 in 1 BLISTER PACK; Type 0: Not a Combination Product05/01/2020
    6NDC:69168-414-085 in 1 BLISTER PACK; Type 0: Not a Combination Product05/01/2020
    7NDC:69168-414-02150 in 1 BOTTLE; Type 0: Not a Combination Product11/06/2023
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA21072205/01/2020
    Labeler - Allegiant Health (079501930)
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