Label: LORATADINE tablet

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

Drug Label Information

Updated February 9, 2026

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. (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

  • .

    **This product is not manufactured or distributed by Bayer Healthcare LLC, distributor of Claritin® Tablets.

    Cartons of 100 tablets (10 tablets each blister pack x 10), NDC 0904-7511-61 

    WARNING: This Unit Dose package is not child resistant and is Intended for Institutional Use Only. Keep this and all drugs out of the reach of children.

    Distributed by MAJOR® PHARMACEUTICALS

    Indianapolis, IN 46268

    (800) 616-2471

    www.major-rugby.com

    Packaged and Distributed by:

    MAJOR® PHARMACEUTICALS

    Indianapolis, IN 46268 USA

    Refer to package label for Distributor's NDC Number

    Rev. 04/25

    M-05

    Re-order No. 701027
  • Principal Display Panel

    MAJOR®

    NDC 0904-7511-61

    Unit Dose

    Original Prescription Strength

    Loratadine

    Tablets

    10 mg

    Antihistamine

    100 TABLETS (10 x 10)

    10mg carton label
  • INGREDIENTS AND APPEARANCE
    LORATADINE 
    loratadine tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0904-7511(NDC:0904-6852)
    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:0904-7511-61100 in 1 CARTON03/18/2025
    11 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA07630103/18/2025
    Labeler - Major Pharmaceuticals (191427277)
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!