Label: LORATADINE tablet

  • NDC Code(s): 58602-702-04, 58602-702-05, 58602-702-09, 58602-702-15, view more
    58602-702-17, 58602-702-19, 58602-702-21, 58602-702-23, 58602-702-29, 58602-702-32, 58602-702-38, 58602-702-39, 58602-702-40, 58602-702-44, 58602-702-54, 58602-702-60, 58602-702-67, 58602-702-81, 58602-702-83, 58602-702-84
  • Packager: Aurohealth LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated August 13, 2020

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  • Drug Facts

  • 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                                                                    
    • 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 (1-800-222-1222) right away.

  • 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


    • Tamper-evident: do not use if foil seal under cap, printed with “SEALED for YOUR PROTECTION” is missing, open or broken
    • store at 20° to 25°C (68° to 77°F)
    • protect from excessive moisture
  • Inactive ingredients

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

  • Questions or comments?


    call 1-855-274-4122
    Distributed by: AUROHEALTH LLC
    2572 Brunswick Pike
    Lawrenceville, NJ 08648
     Made in India

    Code: TS/DRUGS/22/2009

  • PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 10 mg (45 Tablets Bottle)

    NDC 58602-702-17
    Non-Drowsy*
    Loratadine
    Tablets USP 10 mg
    Antihistamine
    24 Hour
    Relief of:

    • Sneezing
    • Runny Nose
    • Itchy, Watery Eyes
    • Itchy Throat or Nose

    Indoor & Outdoor
    Allergies
    *When taken as directed.
    See Drug Facts Panel.             45 Tablets



    PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 10 mg (45 Tablets Bottle)

  • PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 10 mg Container Carton (45 Tablets)

    NDC 58602-702-17
    #Compare to the active
    ingredient in claritin®
    Non-Drowsy*
    Loratadine
    Tablets USP 10 mg
    Antihistamine
    Indoor & Outdoor Allergies
    24 Hour
    Relief of:

    • Sneezing
    • Runny Nose
    • Itchy, Watery Eyes
    • Itchy Throat or Nose

    *When taken as directed
    See Drug Facts Panel.             45 Tablets




    PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 10 mg Container Carton (45 Tablets)

  • PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 10 mg Blister Carton (30 Tablets)

    NDC 58602-702-84
    #Compare to the active
    ingredient in claritin®
    Non-Drowsy*
    Loratadine
    Tablets USP 10 mg
    Antihistamine
    Indoor & Outdoor Allergies
    24 Hour
    Relief of:

    • Sneezing
    • Runny Nose
    • Itchy, Watery Eyes
    • Itchy Throat or Nose

    *When taken as directed.
    See Drug Facts Panel.
    30 Tablets


    PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 10 mg Blister Carton (30 Tablets)

  • INGREDIENTS AND APPEARANCE
    LORATADINE 
    loratadine tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58602-702
    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 POTATO (UNII: 5856J3G2A2)  
    Product Characteristics
    ColorWHITE (White to Off-white) Scoreno score
    ShapeROUNDSize6mm
    FlavorImprint Code 39;L
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:58602-702-171 in 1 CARTON04/16/2018
    145 in 1 BOTTLE; Type 0: Not a Combination Product
    2NDC:58602-702-151 in 1 CARTON04/16/2018
    260 in 1 BOTTLE; Type 0: Not a Combination Product
    3NDC:58602-702-191 in 1 CARTON04/16/2018
    390 in 1 BOTTLE; Type 0: Not a Combination Product
    4NDC:58602-702-811 in 1 CARTON04/16/2018
    4108 in 1 BOTTLE; Type 0: Not a Combination Product
    5NDC:58602-702-321 in 1 CARTON04/16/2018
    5180 in 1 BOTTLE; Type 0: Not a Combination Product
    6NDC:58602-702-601 in 1 CARTON04/16/2018
    65 in 1 BLISTER PACK; Type 0: Not a Combination Product
    7NDC:58602-702-831 in 1 CARTON04/16/2018
    710 in 1 BLISTER PACK; Type 0: Not a Combination Product
    8NDC:58602-702-672 in 1 CARTON04/16/2018
    810 in 1 BLISTER PACK; Type 0: Not a Combination Product
    9NDC:58602-702-843 in 1 CARTON04/16/2018
    910 in 1 BLISTER PACK; Type 0: Not a Combination Product
    10NDC:58602-702-055 in 1 CARTON04/16/2018
    1010 in 1 BLISTER PACK; Type 0: Not a Combination Product
    11NDC:58602-702-091 in 1 CARTON05/03/2019
    1130 in 1 BOTTLE; Type 0: Not a Combination Product
    12NDC:58602-702-381 in 1 CARTON05/03/2019
    12300 in 1 BOTTLE; Type 0: Not a Combination Product
    13NDC:58602-702-391 in 1 CARTON05/03/2019
    13365 in 1 BOTTLE; Type 0: Not a Combination Product
    14NDC:58602-702-441 in 1 CARTON07/26/2019
    14400 in 1 BOTTLE; Type 0: Not a Combination Product
    15NDC:58602-702-541 in 1 CARTON10/04/2019
    1570 in 1 BOTTLE; Type 0: Not a Combination Product
    16NDC:58602-702-231 in 1 CARTON10/04/2019
    16120 in 1 BOTTLE; Type 0: Not a Combination Product
    17NDC:58602-702-401 in 1 CARTON11/28/2019
    17500 in 1 BOTTLE; Type 0: Not a Combination Product
    18NDC:58602-702-211 in 1 CARTON12/23/2019
    18100 in 1 BOTTLE; Type 0: Not a Combination Product
    19NDC:58602-702-0410 in 1 CARTON02/10/2020
    1910 in 1 BLISTER PACK; Type 0: Not a Combination Product
    20NDC:58602-702-291 in 1 CARTON08/13/2020
    20150 in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA20831404/16/2018
    Labeler - Aurohealth LLC (078728447)
    Establishment
    NameAddressID/FEIBusiness Operations
    Aurobindo Pharma Limited650381903ANALYSIS(58602-702) , MANUFACTURE(58602-702)
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