Label: LEADER ALLERGY RELIEF- loratadine tablet

  • NDC Code(s): 70000-0213-1, 70000-0213-2, 70000-0213-3, 70000-0213-4, view more
    70000-0213-5, 70000-0213-6
  • Packager: Cardinal Health 110, LLC. dba Leader
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated June 23, 2021

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

  • Principal Display Panel

    Non-Drowsy* | 24 Hour

    Allergy Relief

    Loratadine Tablets, 10 mg | Antihistamine

    Indoor & Outdoor Allergies

    24 Hour Relief of:

    Sneezing; Runny Nose;

    Itchy, Watery Eyes;

    Itchy Throat or Nose

    COMPARE TO CLARITIN

    active ingredient

    Original Prescription Strength

    100% Money Back Guarantee

    300 TABLETS

    Actual Size

    *When taken as directed.

    See Drug Facts Panel.

    612-e9-allergy-relief.jpg
  • INGREDIENTS AND APPEARANCE
    LEADER ALLERGY RELIEF 
    loratadine tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70000-0213
    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:70000-0213-230 in 1 CARTON12/09/2016
    11 in 1 BLISTER PACK; Type 0: Not a Combination Product
    2NDC:70000-0213-31 in 1 CARTON12/09/2016
    270 in 1 BOTTLE; Type 0: Not a Combination Product
    3NDC:70000-0213-41 in 1 CARTON12/09/2016
    390 in 1 BOTTLE; Type 0: Not a Combination Product
    4NDC:70000-0213-110 in 1 CARTON12/09/2016
    41 in 1 BLISTER PACK; Type 0: Not a Combination Product
    5NDC:70000-0213-540 in 1 CARTON12/13/2017
    51 in 1 BLISTER PACK; Type 0: Not a Combination Product
    6NDC:70000-0213-61 in 1 CARTON01/14/2020
    6300 in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA07630112/09/2016
    Labeler - Cardinal Health 110, LLC. dba Leader (063997360)
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!