Label: FIRST AID DIRECT ALLERGY RELIEF- loratadine tablets tablet

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

Drug Label Information

Updated October 20, 2021

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  • Active Ingredient (in each tablet)

    Loratadine 10 mg

  • Purpose

    Antihistamine

  • Uses

    temporatily relieves these symptoms due to hay fever or other upper respiratory allergies:

    • runny nose 
    • itchy, watery eyes
    • sneezing
    • iching 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 accidental overdose, contact a doctor or Poison Control Center immediately. 

  • 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°C to 25°C (68° to 77°F)
    • protect from excessive moisture
    • do not use if blister unit is torn or open
  • Inactive ingredients

    lactose monohydrate, magensium stearate, pregelatinized starch, sodium startch glycolate

  • Questions?

    1-800-327-2704 Monday - Friday 8:00am - 5:00pm (CDT)

  • Principal Display Panel

    Original Prescription Strength

    Non-Drowsy*

    Allergy Relief

    Loratadine Tablets, 10 mg - Antihistamine

    Indoor & Outdoor Allergies

    †Compare to active ingredient of Claritin®

    Relief of:

    • sneezing 
    • runny nose
    • itchy, watery eyes
    • itchy throat or nose

    24 Hour

    Actual Size

    20 TABLETS 

    *When taken as directed. See drug facts panel

    box-label

  • INGREDIENTS AND APPEARANCE
    FIRST AID DIRECT ALLERGY RELIEF 
    loratadine tablets tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:42961-120
    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)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    SODIUM STARCH GLYCOLATE TYPE A (UNII: H8AV0SQX4D)  
    Product Characteristics
    ColorwhiteScoreno score
    ShapeROUNDSize10mm
    FlavorImprint Code 439
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:42961-120-022 in 1 BOX10/20/2021
    110 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA21072210/20/2021
    Labeler - Cintas Corporation (056481716)
    Establishment
    NameAddressID/FEIBusiness Operations
    Granules India Limitied918609236manufacture(42961-120)
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