Label: LORATADINE tablet

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

Drug Label Information

Updated April 11, 2024

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

  • 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

    Repackaged By: Preferred Pharmaceuticals Inc.

  • PACKAGE LABEL- PRINCIPAL DISPLAY PANEL - 10mg

    NDC 68788-8628

    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.

    Loratadine Tablets 10mg
  • INGREDIENTS AND APPEARANCE
    LORATADINE 
    loratadine tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68788-8628(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:68788-8628-010 in 1 BOTTLE; Type 0: Not a Combination Product04/11/2024
    2NDC:68788-8628-114 in 1 BOTTLE; Type 0: Not a Combination Product04/11/2024
    3NDC:68788-8628-515 in 1 BOTTLE; Type 0: Not a Combination Product04/11/2024
    4NDC:68788-8628-330 in 1 BOTTLE; Type 0: Not a Combination Product04/11/2024
    5NDC:68788-8628-990 in 1 BOTTLE; Type 0: Not a Combination Product04/11/2024
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA20831404/11/2024
    Labeler - Preferred Pharmaceuticals Inc. (791119022)
    Registrant - Preferred Pharmaceuticals Inc. (791119022)
    Establishment
    NameAddressID/FEIBusiness Operations
    Preferred Pharmaceuticals Inc.791119022REPACK(68788-8628)