Label: LORATADINE tablet, orally disintegrating

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

Drug Label Information

Updated November 5, 2023

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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

    •
    place 1 tablet on tongue; tablet disintegrates, with or without water

    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 blister unit is broken or torn
    •
    store between 20° to 25°C (68° to 77°F)
    •
    use tablet immediately after opening individual blister
  • Inactive ingredients

    croscarmellose sodium, crospovidone, hypromellose, magnesium stearate, mannitol, microcrystalline cellulose, natural and artificial mint flavor, sucralose

  • Questions or comments?

    1-800-719-9260

  • Package/Label Principal Display Panel

    FREE FROM | GLUTEN FREE

    Compare to the active ingredient of Claritin® RediTabs®

    24 HOUR

    ORIGINAL PRESCRIPTION STRENGTH

    LORATADINE

    ORALLY DISINTEGRATING TABLETS, 10 mg

    ANTIHISTAMINE

    NON-DROWSY*

    INDOOR & OUTDOOR ALLERGIES

    24 HOUR RELIEF OF

    Sneezing – Runny nose – Itchy, watery eyes

    Itchy throat or nose

    ACTUAL SIZE

    NO WATER NEEDED

    MELTS IN YOUR MOUTH

    *WHEN TAKEN AS DIRECTED. SEE DRUG FACTS PANEL.

    30 TABLETS

    loratadine-image
  • INGREDIENTS AND APPEARANCE
    LORATADINE 
    loratadine tablet, orally disintegrating
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11822-0558
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    LORATADINE (UNII: 7AJO3BO7QN) (LORATADINE - UNII:7AJO3BO7QN) LORATADINE10 mg
    Inactive Ingredients
    Ingredient NameStrength
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    CROSPOVIDONE (15 MPA.S AT 5%) (UNII: 68401960MK)  
    HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MANNITOL (UNII: 3OWL53L36A)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    Product Characteristics
    ColorWHITEScoreno score
    ShapeROUNDSize6mm
    FlavorImprint Code L;L
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:11822-0558-030 in 1 CARTON07/17/2020
    11 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA07601107/17/2020
    Labeler - Rite Aid Corporation (014578892)
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