Label: CAREONE ALLERGY RELIEF 24 HOUR- loratadine tablet

  • NDC Code(s): 41520-612-03, 41520-612-46, 41520-612-58, 41520-612-60, view more
    41520-612-65, 41520-612-72, 41520-612-75, 41520-612-76, 41520-612-82, 41520-612-95
  • Packager: American Sales Company
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated March 12, 2020

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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 printed foil under cap is broken or missing
    •
    store between 20° to 25°C (68° to 77°F)
  • Inactive ingredients

    lactose monohydrate, magnesium stearate, povidone, pregelatinized starch

  • Questions or comments?

    1-800-719-9260

  • Principal Display Panel

    BONUS SIZE | 33% MORE

    Compare to the active ingredient in Claritin®

    24hr

    ORIGINAL PRESCRIPTION STRENGTH

    Non-Drowsy*

    Allergy Relief

    Loratadine Tablets, 10 mg

    Antihistamine

    Actual Size

    40 TABLETS

    INDOOR & OUTDOOR ALLERGIES

    24 HOUR RELIEF OF:

    Sneezing

    Runny Nose

    Itchy, Watery Eyes

    Itchy Throat Or Nose

    OUR PHARMACISTS RECOMMEND

    *When taken as directed.

    See Drug Facts Panel.

    612OF-allergy-relief.jpg
  • INGREDIENTS AND APPEARANCE
    CAREONE ALLERGY RELIEF  24 HOUR
    loratadine tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:41520-612
    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:41520-612-4610 in 1 CARTON06/02/2006
    11 in 1 BLISTER PACK; Type 0: Not a Combination Product
    2NDC:41520-612-6020 in 1 CARTON06/02/200609/07/2014
    21 in 1 BLISTER PACK; Type 0: Not a Combination Product
    3NDC:41520-612-651 in 1 CARTON03/28/2007
    330 in 1 BOTTLE; Type 0: Not a Combination Product
    4NDC:41520-612-761 in 1 CARTON02/27/2007
    4120 in 1 BOTTLE; Type 0: Not a Combination Product
    5NDC:41520-612-751 in 1 CARTON06/27/2006
    590 in 1 BOTTLE; Type 0: Not a Combination Product
    6NDC:41520-612-721 in 1 CARTON06/27/200601/28/2015
    660 in 1 BOTTLE; Type 0: Not a Combination Product
    7NDC:41520-612-821 in 1 CARTON02/25/2014
    7200 in 1 BOTTLE; Type 0: Not a Combination Product
    8NDC:41520-612-951 in 1 CARTON10/13/2014
    845 in 1 BOTTLE; Type 0: Not a Combination Product
    9NDC:41520-612-031 in 1 CARTON08/29/2014
    970 in 1 BOTTLE; Type 0: Not a Combination Product
    10NDC:41520-612-581 in 1 CARTON02/25/2020
    1040 in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA07630106/02/2006
    Labeler - American Sales Company (809183973)
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