Label: ALL DAY ALLERGY RELIEF- loratadine tablet

  • NDC Code(s): 59726-915-10, 59726-915-30, 59726-915-90
  • Packager: P & L Development, LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated October 17, 2022

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

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

  • Principal Display Panel

    Compare to the active ingredient in Claritin® 24 Hour†

    all day allergy relief

    loratadine 10 mg tablets

    antihistamine

    non-drowsy*

    Indoor & Outdoor Allergies

    24 hour relief of:

    • sneezing
    • runny nose
    • itchy, watery eyes
    • itchy throat or nose

    gluten-free

    *when taken as directed, see drug facts panel.

    tablets

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

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

    KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION

    Distributed by:

    PL Developments

    200 Hicks Street

    Westbury, NY 11590

  • Package Label

    Loratadine, USP 10 mg

    READYinCASE All Day Allergy Relief

  • INGREDIENTS AND APPEARANCE
    ALL DAY ALLERGY RELIEF 
    loratadine tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59726-915
    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:59726-915-3030 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product10/30/2019
    2NDC:59726-915-1010 in 1 CARTON10/30/2019
    21 in 1 BLISTER PACK; Type 0: Not a Combination Product
    3NDC:59726-915-901 in 1 BOX10/30/2019
    390 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA07520910/30/2019
    Labeler - P & L Development, LLC (800014821)