Label: INDOOR OUTDOOR ALLERGY RELIEF- loratadine tablet

  • NDC Code(s): 0363-0858-03, 0363-0858-05, 0363-0858-10, 0363-0858-15, view more
    0363-0858-20, 0363-0858-30, 0363-0858-45, 0363-0858-70, 0363-0858-90
  • Packager: Walgreens
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated November 30, 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 right away (1-800-222-1222)

  • 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 1-877-753-3935 Monday-Friday 9AM-5PM EST

  • Principal Display Panel

    Compare to Claritin® Tablets active ingredient††

    NON-DROWSY* • ORIGINAL

    PRESCRIPTION STRENGTH

    24 HOUR ALLERGY

    LORATADINE TABLETS, 10 mg / ANTIHISTAMINE

    24 HOUR TABLETS

    INDOOR & OUTDOOR ALLERGIES

    • 24-hour relief of sneezing, runny nose, itchy, watery eyes & itchy throat or nose

    *WHEN TAKEN AS DIRECTED. SEE DRUG FACTS PANEL.

    TABLETS

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

    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: WALGREEN CO.

    200 WILMOT RD., DEERFIELD, IL 60015

    walgreens.com


  • Package Label

    Loratadine, USP 10 mg

    WALGREENS Indoor & Outdoor Allergy Relief

  • INGREDIENTS AND APPEARANCE
    INDOOR OUTDOOR ALLERGY RELIEF 
    loratadine tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0363-0858
    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:0363-0858-1010 in 1 CARTON09/30/2018
    11 in 1 BLISTER PACK; Type 0: Not a Combination Product
    2NDC:0363-0858-2020 in 1 CARTON09/30/2018
    21 in 1 BLISTER PACK; Type 0: Not a Combination Product
    3NDC:0363-0858-055 in 1 CARTON09/30/2018
    31 in 1 BLISTER PACK; Type 0: Not a Combination Product
    4NDC:0363-0858-301 in 1 BOX09/30/2018
    4300 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    5NDC:0363-0858-151 in 1 CARTON09/30/2018
    5150 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    6NDC:0363-0858-901 in 1 BOX09/30/2018
    690 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    7NDC:0363-0858-701 in 1 BOX09/30/2018
    770 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    8NDC:0363-0858-451 in 1 BOX09/30/2018
    845 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    9NDC:0363-0858-031 in 1 BOX09/30/2018
    930 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA07520909/30/2018
    Labeler - Walgreens (008965063)
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