Label: LORATADINE 10MG tablet

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

Drug Label Information

Updated December 18, 2024

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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

  • 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.

  • Directions

    adults and 1 tablet daily; not more
    than 1 tablet in 24 hours
    children 6 years
    and over

    children under ask a doctor
    6 years of age

    consumers with ask a doctor
    liver or kidney
    disease

  • Other information

     Tamper evident: do not use if imprinted seal under cap, printed with "SEALED FOR YOUR PROTECTION" is missing, open or broken
     store between 20° to 25°C (68° to 77°F)

  • Inactive ingredients

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

  • Questions or comments?

    contact 1-877-770-3183 Mon-Fri 8:00 AM EST to 5:00 PM PST

  • PDP

    Loratadine 10mg

  • INGREDIENTS AND APPEARANCE
    LORATADINE 10MG 
    loratadine 10mg tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:79481-7870
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    LORATADINE (UNII: 7AJO3BO7QN) (LORATADINE - UNII:7AJO3BO7QN) LORATADINE10 mg
    Inactive Ingredients
    Ingredient NameStrength
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
    Product Characteristics
    Colorwhite ((White to off white)) Scoreno score
    ShapeROUNDSize6mm
    FlavorImprint Code G;10
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:79481-7870-370 in 1 BOTTLE; Type 0: Not a Combination Product09/09/2024
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA21072209/09/2024
    Labeler - Meijer (006959555)
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