Label: ALLERGY RELIEF- loratadine tablet

  • NDC Code(s): 63868-414-01
  • Packager: QUALITY CHOICE (Chain Drug Marketing Association)
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated November 8, 2022

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  • 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
    • sneezing
    • itchy, watery eyes
    • 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 (1-800-222-1222) right away. 

  • Directions

    adults and children 6 years and over1 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 at 20º-25ºC (68º-77ºF) (see UPS Controlled Room Temperature)
    • protect from light
  • Inactive ingredients

    lactose monohydrate, magnesium stearate, microcrystalline cellulose, sodium starch glycolate

  • Questions or comments?

    Call 800-935-2362 Monday-Friday 9AM-5PM EST

  • Principal Display Panel

    †Compare to the Active Ingredient in Claritin® 24 Hour

    Original Prescription Strength

    Allergy Relief

    Loratadine 10 mg Tablets

    Antihistamine

    Indoor & Outdoor Allergies

    Relief of:

    Sneezing | Runny Nose

    Itchy, Watery Eyes | Itchy Throat or Nose

    Gluten Free

    24 Hour Allergy Relief

    Non-Drowsy*

    Tablets

    *When taken as directed. See Drug Facts panel.

    †This product is not manufactured or distributed by Bayer Healthcare LLC, distributor of Claritin® 24 Hour

    TAMPER EVIDENT: DO NOT USE IF PRINTED SFETY SEAL UNDER CAP IS BROKEN OR MISSING

    KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION

    Distributed by C.D.M.A., Inc.©

    43157 W 9 Mile Rd

    Novi, MI 48375

    www.qualitychoice.com

  • Package Label

    Loratadine, USP 10 mg

    QUALITY CHOICE Allergy Relief

  • INGREDIENTS AND APPEARANCE
    ALLERGY RELIEF 
    loratadine tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63868-414
    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)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    SODIUM STARCH GLYCOLATE TYPE A CORN (UNII: AG9B65PV6B)  
    Product Characteristics
    ColorwhiteScoreno score
    ShapeROUNDSize6mm
    FlavorImprint Code 439
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:63868-414-011 in 1 BOX04/15/2021
    1100 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA07520904/15/2021
    Labeler - QUALITY CHOICE (Chain Drug Marketing Association) (011920774)
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