Label: LORATADINE tablet

  • NDC Code(s): 0363-9787-01, 0363-9787-02, 0363-9787-14
  • Packager: Walgreens
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated February 27, 2024

If you are a consumer or patient please visit this version.

View All Sections
  • 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.

  • Directions

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

    children under ask a doctor
    6 years of age

    consumers with liver ask a doctor
    or kidney disease

  • Other information

    ■ safety sealed: do not use if the individual blister unit if open or torn
    ■ store between 20° to 25° C (68° to 77°F)
    ■ protect from excessive moisture

  • Inactive ingredients

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

  • Questions or comments?

    Contact 1-877-770-3183 Mon-Fri 9:00 AM to 4:30 PM EST

  • PDP

    Loratadine 10mgLoratadine 10mgLoratadine 10mg

  • INGREDIENTS AND APPEARANCE
    LORATADINE 
    loratadine tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0363-9787
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    LORATADINE (UNII: 7AJO3BO7QN) (LORATADINE - UNII:7AJO3BO7QN) LORATADINE10 mg
    Inactive Ingredients
    Ingredient NameStrength
    SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    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:0363-9787-0110 in 1 BLISTER PACK; Type 0: Not a Combination Product01/01/2024
    2NDC:0363-9787-0220 in 1 BLISTER PACK; Type 0: Not a Combination Product01/01/2024
    3NDC:0363-9787-145 in 1 BLISTER PACK; Type 0: Not a Combination Product01/01/2024
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA21072201/01/2024
    Labeler - Walgreens (008965063)
View All Sections

Find additional resources

(also available in the left menu)

Safety

Report Adverse Events, FDA Safety Recalls, Presence in Breast Milk

Related Resources

Medline Plus, Clinical Trials, PubMed, Biochemical Data Summary

More Info on this Drug

View Labeling Archives, RxNorm, Get Label RSS Feed, View NDC Code(s)NEW!