Label: ALLERGY RELIEF NON DROWSY- loratadine tablet

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated July 25, 2023

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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 over

    1 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 1-888-588-1418 Monday-Friday 9AM-5PM EST

  • Principal Display Panel

    †Compare to the active ingredient in Claritin® 24 Hour

    Non-drowsy*

    Allergy Relief

    Loratadine Tablets, USP 10 mg / Antihistamine

    Indoor & outdoor  allergies

    24 Hour Relief of:

    •
    Sneezing
    •
    Runny Nose
    •
    Itchy, Watery Eyes
    •
    Itchy Nose or Throat

    Tablets

    Gluten-Free

    *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 SAFETY SEAL UNDER CAPS IS BROKEN OR MISSING.

    Distributed by:

    Camber Consumer Care Inc., Piscataway, NJ 08854, USA

    Repackaged By: Preferred Pharmaceuticals Inc.

  • Package Label

    Loratadine Tablets 10mg

    CAMBER CONSUMER CARE Non-Drowsy Allergy Relief

  • INGREDIENTS AND APPEARANCE
    ALLERGY RELIEF  NON DROWSY
    loratadine tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68788-7769(NDC:69230-317)
    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:68788-7769-010 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product08/03/2020
    2NDC:68788-7769-114 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product08/03/2020
    3NDC:68788-7769-515 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product08/03/2020
    4NDC:68788-7769-330 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product08/03/2020
    5NDC:68788-7769-990 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product08/03/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA07520908/03/2020
    Labeler - Preferred Pharmaceuticals, Inc. (791119022)
    Registrant - Preferred Pharmaceuticals, Inc. (791119022)
    Establishment
    NameAddressID/FEIBusiness Operations
    Preferred Pharmaceuticals, Inc.791119022REPACK(68788-7769)
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