Label: LORATADINE tablet

  • NDC Code(s): 68210-4110-1
  • Packager: Spirit Pharmaceuticals LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated December 8, 2023

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  • Active ingredient

    Loratadine 10 mg

  • Purpose

    Antihistamine

  • Uses

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

    •  runny nose
    •  sneezing
    • itchy, water 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 usung 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.

  • 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

    • Tamper-evident: do not use if foil under cap is missing, open or broken
    • store between 20º to 25ºC (68º to 77ºF)

  • Inactive ingredients

    Lactose monohydrate, magnesium stearate, sodium starch glycolate and starch maize pregelatinized

  • Questions or comments? 

    1-888-333-9792

  • PRINCIPAL DISPLAY PANEL

    Compare to the active ingredient in Claritin®†

    NON-DROWSY*

    Original Prescription Strength

    Loratadine Tablets, 10 mg / Antihistamine

    Indoor & Outdoor Allergies

    24 Hour Relief of: • Sneezing • Runny Nose • Itchy, Watery Eyes • Itchy Throat or Nose

    365 Tablets

    *When taken as directed

    See Drug Facts Panel

    †This product is not manufactured or distributed by Bayer Healthcare, LLC, owner of the registered trademark Claritin®.

    Loratadine

  • INGREDIENTS AND APPEARANCE
    LORATADINE 
    loratadine tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68210-4110
    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)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
    Product Characteristics
    Colorwhite (White to off white) Scoreno score
    ShapeROUNDSize6mm
    FlavorImprint Code G;10
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:68210-4110-1365 in 1 BOTTLE; Type 0: Not a Combination Product09/11/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA21072209/11/2020
    Labeler - Spirit Pharmaceuticals LLC (179621011)
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