Label: ALLERGY RELIEF NON DROWSY- loratadine tablet

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

Drug Label Information

Updated December 28, 2021

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

View All Sections
  • Active ingredient (in each tablet)

    Loratadine, USP 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.

    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 years of age  ask a doctor 
    consumers with liver or kidney disease ask a doctor

  • Other information

    • store at 20º-25ºC (68º-77ºF) (see UPS Controlled Room Temperature)
  • Inactive ingredients

    lactose monohydrate, magnesium stearate, microcrystalline cellulose, sodium starch glycolate

  • Questions or comments?

    Call 1-888-588-1418 Monday-Friday 9AM-5PM EST

  • HOW SUPPLIED

    NDC: 71335-1461-1: 20 Tablets in a BOTTLE

    NDC: 71335-1461-2: 30 Tablets in a BOTTLE

    NDC: 71335-1461-3: 60 Tablets in a BOTTLE

    NDC: 71335-1461-4: 14 Tablets in a BOTTLE

    NDC: 71335-1461-5: 10 Tablets in a BOTTLE

    NDC: 71335-1461-6: 90 Tablets in a BOTTLE

    NDC: 71335-1461-7: 28 Tablets in a BOTTLE

    NDC: 71335-1461-8: 15 Tablets in a BOTTLE

    NDC: 71335-1461-9: 100 Tablets in a BOTTLE

  • PRINCIPAL DISPLAY PANEL

    Loratadine 10mg Tablet

    Label
  • INGREDIENTS AND APPEARANCE
    ALLERGY RELIEF  NON DROWSY
    loratadine tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71335-1461(NDC:69230-312)
    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)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    SODIUM STARCH GLYCOLATE TYPE A CORN (UNII: AG9B65PV6B)  
    Product Characteristics
    ColorwhiteScoreno score
    ShapeROUNDSize6mm
    FlavorImprint Code GG296
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:71335-1461-120 in 1 BOTTLE; Type 0: Not a Combination Product01/03/2020
    2NDC:71335-1461-230 in 1 BOTTLE; Type 0: Not a Combination Product01/30/2020
    3NDC:71335-1461-360 in 1 BOTTLE; Type 0: Not a Combination Product12/28/2021
    4NDC:71335-1461-414 in 1 BOTTLE; Type 0: Not a Combination Product12/28/2021
    5NDC:71335-1461-510 in 1 BOTTLE; Type 0: Not a Combination Product05/19/2020
    6NDC:71335-1461-690 in 1 BOTTLE; Type 0: Not a Combination Product01/13/2020
    7NDC:71335-1461-728 in 1 BOTTLE; Type 0: Not a Combination Product12/28/2021
    8NDC:71335-1461-815 in 1 BOTTLE; Type 0: Not a Combination Product12/28/2021
    9NDC:71335-1461-9100 in 1 BOTTLE; Type 0: Not a Combination Product12/28/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA07520912/31/2018
    Labeler - Bryant Ranch Prepack (171714327)
    Registrant - Bryant Ranch Prepack (171714327)
    Establishment
    NameAddressID/FEIBusiness Operations
    Bryant Ranch Prepack171714327REPACK(71335-1461) , RELABEL(71335-1461)
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!