FAD FIRST AID DIRECT ALLERGY RELIEF (LORATADINE) TABLET [FIRST AID DIRECT]

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FAD FIRST AID DIRECT ALLERGY RELIEF (LORATADINE) TABLET [FIRST AID DIRECT]
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NDC 53117-612-60
Set ID d86c8340-23f4-4e10-8634-ce7bc5fb3608
Category HUMAN OTC DRUG LABEL
Packager First Aid Direct
Generic Name
Product Class
Product Number
Application Number ANDA076301
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  • Active ingredient (in each tablet)

    Loratadine 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 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

    •
    do not use if blister unit is broken or torn
    •
    store between 20° to 25°C (68° to 77°F)
    •
    protect from excessive moisture
  • Inactive ingredients

    lactose monohydrate, magnesium stearate, povidone, pregelatinized starch

  • Questions or comments?

    1-800-719-9260

  • 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.

    Allergy Relief Image 1
    Allergy Relief Image 2
  • INGREDIENTS AND APPEARANCE
    FAD FIRST AID DIRECT ALLERGY RELIEF 
    loratadine tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53117-612
    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)  
    POVIDONES (UNII: FZ989GH94E)  
    Product Characteristics
    ColorWHITEScoreno score
    ShapeOVALSize8mm
    FlavorImprint Code L612
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:53117-612-6020 in 1 CARTON
    11 in 1 BLISTER PACK
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA07630112/19/2012
    Labeler - First Aid Direct (962283128)
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