Label: SUNMARK LORATADINE- loratadine tablet

  • NDC Code(s): 49348-818-01, 49348-818-12, 49348-818-13, 49348-818-44, view more
    49348-818-45, 49348-818-56
  • Packager: Strategic Sourcing Services LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated March 25, 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

    COMPARE TO CLARITIN® TABLETS ACTIVE INGREDIENT

    24 HOUR

    loratadine tablets, 10 mg

    Antihistamine

    24 hour relief of sneezing; runny nose;

    itchy, watery eyes;

    itchy throat or nose

    Indoor & Outdoor Allergies

    ORIGINAL PRESCRIPTION STRENGTH

    NON-DROWSY*

    Actual Size

    *When taken as directed.

    See Drug Facts Panel.

    GLUTEN FREE

    70 TABLETS

    612S1-loratadine.jpg
  • INGREDIENTS AND APPEARANCE
    SUNMARK LORATADINE 
    loratadine tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49348-818
    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:49348-818-0110 in 1 CARTON06/25/2007
    11 in 1 BLISTER PACK; Type 0: Not a Combination Product
    2NDC:49348-818-4430 in 1 CARTON06/21/2007
    21 in 1 BLISTER PACK; Type 0: Not a Combination Product
    3NDC:49348-818-121 in 1 CARTON07/13/200706/07/2015
    360 in 1 BOTTLE; Type 0: Not a Combination Product
    4NDC:49348-818-131 in 1 CARTON06/21/2007
    490 in 1 BOTTLE; Type 0: Not a Combination Product
    5NDC:49348-818-561 in 1 CARTON03/31/2014
    570 in 1 BOTTLE; Type 0: Not a Combination Product
    6NDC:49348-818-451 in 1 CARTON10/24/2018
    630 in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA07630106/21/2007
    Labeler - Strategic Sourcing Services LLC (116956644)
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