Label: LORATADINE tablet

  • NDC Code(s): 68001-438-00, 68001-438-04, 68001-438-16, 68001-438-96, view more
    68001-438-97
  • Packager: BluePoint Laboratories
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated June 20, 2022

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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 an 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°C 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

    Manufactured by: Aurobindo Pharma Limited

    Hyderabad-509 302,

    INDIA

    For BluePoint Laboratories

    MADE IN INDIA

    Code: TS/DRUGS/22/2009

    Issued: 04/2020

  • PACKAGE LABEL- PRINCIPAL DISPLAY PANEL - 10mg (100 Tablets Bottle)

    NDC 68001-438-00

    Non-Drowsy*

    Loratadine

    Tablets USP 10mg

    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. 100 Tablets

    10mg Bottle Label

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

    NDC 68001-438-04

    #Compare to the active ingredient in claritin®

    Non-Drowsy*

    Loratadine

    Tablets USP 10mg

    Antihisamine

    Indoor and 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

    10mg Carton

  • PACKAGE LABEL-PRINCIPAL DISPLAY PANEL- 10 mg Blister Carton (100 Tablets)

    NDC 68001-438-96

    #Compare to the active

    ingredient in claritin®

    Non-Drowsy*

    Loratadine

    Tablets USP 10mg

    Antihisamine

    Indoor and outdoor allergies

    24 Hour

    Relief of:

    Sneezing

    Runny Nose

    Itchy, Watery Eyes

    Itchy Throat or Nose

    *When taken as directed.

    See Drug Facts Panel. 100 Tablets

    10mg Blister

  • INGREDIENTS AND APPEARANCE
    LORATADINE 
    loratadine tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68001-438
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    LORATADINE (UNII: 7AJO3BO7QN) (LORATADINE - UNII:7AJO3BO7QN) LORATADINE10 mg
    Inactive Ingredients
    Ingredient NameStrength
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
    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:68001-438-001 in 1 CARTON08/26/2020
    1100 in 1 BOTTLE; Type 0: Not a Combination Product
    2NDC:68001-438-9610 in 1 CARTON08/26/2020
    2NDC:68001-438-1610 in 1 BLISTER PACK; Type 0: Not a Combination Product
    3NDC:68001-438-041 in 1 CARTON08/26/2020
    330 in 1 BOTTLE; Type 0: Not a Combination Product
    4NDC:68001-438-971 in 1 CARTON08/26/2020
    4300 in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA20831408/26/2020
    Labeler - BluePoint Laboratories (985523874)
    Establishment
    NameAddressID/FEIBusiness Operations
    Aurobindo Pharma Limited650381903analysis(68001-438) , manufacture(68001-438)
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