Label: LORATADINE ALLERGY RELIEF 10MG- loratadine tablet

  • NDC Code(s): 73581-230-01, 73581-230-36
  • Packager: YYBA CORP
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated January 3, 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
    • sneezing
    • itchy, watery 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 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

    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 over1 tablet daily; not more than 1 tablet in 24 hours
    children under 6 yesrs of ageask a doctor
    consumers with liver or kidney diseaseask a doctor

  • Other information

    • store between 20° and 25°C (68° and 77°F)
    • protect from excessive moisture
  • Inactive ingredients

    lactose monohydrate, magnesium stearate, pregelatinized starch (maize), sodium starch, glycolate.

  • Questions?

    call toll-free 1-866-933-6337

  • PRINCIPAL DISPLAY PANEL

    01b LBL_Welmate_Loratadine Allergey Relief_10mg_100ct_G7043-100-103-0_PDP

    01b LBL_Welmate_Loratadine Allergey Relief_10mg_365ct_G7043-365-103-0_PDP

    01b LBL_Welmate_Loratadine Allergey Relief_10mg_365ct_G7043-365-103-0_DF1

    01b LBL_Welmate_Loratadine Allergey Relief_10mg_365ct_G7043-365-103-0_DF2

  • INGREDIENTS AND APPEARANCE
    LORATADINE ALLERGY RELIEF   10MG
    loratadine tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:73581-230
    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)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    SODIUM STARCH GLYCOLATE TYPE A (UNII: H8AV0SQX4D)  
    Product Characteristics
    ColorwhiteScoreno score
    ShapeROUNDSize7mm
    FlavorImprint Code G;10
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:73581-230-01100 in 1 BOTTLE; Type 0: Not a Combination Product04/15/2022
    2NDC:73581-230-36365 in 1 BOTTLE; Type 0: Not a Combination Product04/15/2022
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA21072204/15/2022
    Labeler - YYBA CORP (006339772)
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!