Label: TOPCARE ALLERGY RELIEF 24 HOUR- loratadine tablet

  • NDC Code(s): 36800-612-03, 36800-612-46, 36800-612-58, 36800-612-65, view more
    36800-612-72, 36800-612-76, 36800-612-87
  • Packager: Topco Associates LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated November 29, 2021

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  • Active ingredient (in each tablet)

    Loratadine 10 mg

  • Purpose

    Antihistamine

  • Uses

    temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:

    •
    runny nose
    •
    itchy, watery eyes
    •
    sneezing
    •
    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 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

    •
    do not use if blister unit is broken or torn
    •
    store between 20° to 25°C (68° to 77°F)
    •
    protect from excessive moisture
  • Inactive ingredients

    lactose monohydrate, magnesium stearate, povidone, pregelatinized starch

  • Questions or comments?

    1-888-423-0139

  • Principal Display Panel

    COMPARE TO CLARITIN® TABLETS ACTIVE INGREDIENT

    NON-DROWSY*

    ORIGINAL PRESCRIPTION STRENGTH

    Allergy Relief

    LORATADINE TABLETS, 10 mg ● ANTIHISTAMINE

    INDOOR & OUTDOOR ALLERGIES

    24 HOUR

    RELIEF OF:

    ● Sneezing

    ● Runny Nose

    ● Itchy, Watery Eyes

    ● Itchy Throat or Nose

    10 TABLETS

    *When taken as directed. See Drug Facts Panel.

    actual size

    61288-allergy-relief
  • INGREDIENTS AND APPEARANCE
    TOPCARE ALLERGY RELIEF  24 HOUR
    loratadine tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:36800-612
    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)  
    POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)  
    Product Characteristics
    ColorWHITEScoreno score
    ShapeOVALSize8mm
    FlavorImprint Code L612
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:36800-612-651 in 1 CARTON01/25/2005
    130 in 1 BOTTLE; Type 0: Not a Combination Product
    2NDC:36800-612-721 in 1 CARTON03/24/200508/17/2011
    260 in 1 BOTTLE; Type 0: Not a Combination Product
    3NDC:36800-612-761 in 1 CARTON12/18/200911/20/2021
    3120 in 1 BOTTLE; Type 0: Not a Combination Product
    4NDC:36800-612-871 in 1 CARTON12/18/2009
    4300 in 1 BOTTLE; Type 0: Not a Combination Product
    5NDC:36800-612-4610 in 1 CARTON01/28/2005
    51 in 1 BLISTER PACK; Type 0: Not a Combination Product
    6NDC:36800-612-581 in 1 CARTON02/19/2014
    640 in 1 BOTTLE; Type 0: Not a Combination Product
    7NDC:36800-612-031 in 1 CARTON03/05/2014
    770 in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA07630101/25/2005
    Labeler - Topco Associates LLC (006935977)
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