Label: ALLERGY RELIEF- loratadine tablet

  • NDC Code(s): 63868-462-01, 63868-462-10, 63868-462-30
  • 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 4, 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
  • Inactive ingredients

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

  • Questions or comments?

    Call 1-248-449-9300 Monday-Friday 9AM-5PM EST

  • Principal Display Panel

    †Compare to the Active Ingredient in Claritin®

    Original Prescription Strength

    Allergy Relief

    Loratadine Tablets, USP

    10 mg | 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®.

    TAMPER EVIDENT: DO NOT USE IF CARTON IS OPENED OR IF BLISTER UNIT IS TORN, BROKEN OR SHOW ANY SIGN OF TAMPERING.

    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:63868-462
    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 GG296
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:63868-462-1010 in 1 CARTON02/28/201902/28/2025
    11 in 1 BLISTER PACK; Type 0: Not a Combination Product
    2NDC:63868-462-301 in 1 BOX02/28/201902/28/2025
    230 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    3NDC:63868-462-011 in 1 BOX02/28/201902/28/2025
    3100 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA07520902/28/201902/28/2025
    Labeler - QUALITY CHOICE (Chain Drug Marketing Association) (011920774)
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