Label: ALLERGY RELIEF- loratadine tablet

  • NDC Code(s): 69168-407-08, 69168-407-09, 69168-407-10, 69168-407-30
  • Packager: Allegiant Health
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated December 12, 2019

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

  • 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
    • itching of the nose or throat 
    • sneezing

  • 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

    If pregnant or breast-feeding, ask a health professional before use.

    Keep out of reach of children

    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. no 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, microcrystalline cellulose, sodium starch glycolate

  • Principal Display Panel

    Allergy Relief

    Allergy Relief

  • INGREDIENTS AND APPEARANCE
    ALLERGY RELIEF 
    loratadine tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69168-407
    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)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    SODIUM STARCH GLYCOLATE TYPE A CORN (UNII: AG9B65PV6B)  
    Product Characteristics
    ColorWHITEScoreno score
    ShapeROUNDSize6mm
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69168-407-091 in 1 CARTON12/16/2014
    110 in 1 BLISTER PACK; Type 0: Not a Combination Product
    2NDC:69168-407-081 in 1 CARTON12/16/2014
    25 in 1 BLISTER PACK; Type 0: Not a Combination Product
    3NDC:69168-407-301 in 1 CARTON12/16/2014
    330 in 1 BOTTLE; Type 0: Not a Combination Product
    4NDC:69168-407-101000 in 1 BOTTLE; Type 0: Not a Combination Product12/16/2014
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA07520912/16/2014
    Labeler - Allegiant Health (079501930)