Label: ALLERGY RELIEF- loratadine tablet

  • NDC Code(s): 67091-350-10, 67091-350-30
  • Packager: WinCo Foods, LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated May 10, 2022

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

View All Sections
  • 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 1-800-824-1706 Monday-Friday 9AM-4PM MST

  • Principal Display Panel

    †When taken as directed. See Drugs Facts Panel.

    *Compare to the active ingredient in CLARITIN® 24 HOUR

    24 HOUR NON-DROWSY†

    Allergy Relief

    Indoor & Outdoor Allergies

    Original Prescription Strength

    Relief of: Sneezing, Runny Nose, Itchy, Watery Eyes & Itchy Throat or Nose

    LORATADINE TABLETS,

    USP 10 mg / ANTIHISTAMINE

    Tablets

    *This product is not manufactured or distributed by BAYER HEALTHCARE LLC, distributor of CLARITIN®. 24 HOUR.

    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: WINCO FOODS, LLC, BOISE, IS 83704

  • Package Label

    Loratadine, USP 10 mg

    WINCO FOODS Non-Drowsy Allergy Relief

  • INGREDIENTS AND APPEARANCE
    ALLERGY RELIEF 
    loratadine tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:67091-350
    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:67091-350-1010 in 1 CARTON01/15/2020
    11 in 1 BLISTER PACK; Type 0: Not a Combination Product
    2NDC:67091-350-3030 in 1 CARTON01/15/2020
    21 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA07520901/15/2020
    Labeler - WinCo Foods, LLC (056098817)
View All Sections

Find additional resources

(also available in the left menu)

Safety

Report Adverse Events, FDA Safety Recalls, Presence in Breast Milk

Related Resources

Medline Plus, Clinical Trials, PubMed, Biochemical Data Summary

More Info on this Drug

View Labeling Archives, RxNorm, Get Label RSS Feed, View NDC Code(s)NEW!