Label: LORATADINE- loratadine tablet

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

Drug Label Information

Updated June 18, 2025

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  • ACTIVE INGREDIENT(S)

    Active ingredient (in each tablet)
    Loratadine USP, 10 mg


  • PURPOSE

    Antihistamine

  • USE(S)

    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.

  • ASK A DOCTOR OR PHARMACIST BEFORE USE IF

  • WHEN USING THIS PRODUCT

    do not take more than directed. Taking more than directed may cause drowsiness.

  • STOP USE AND ASK DOCTOR IF

    an allergic reaction to this product occurs. Seek medical help right away.

  • PREGNANCY/BREASTFEEDING


    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.

  • 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

    Bottles:

    • Tamper-evident: do not use if foil seal under cap, printed with "SEALED for YOUR PROTECTION" is missing, open or broken
    • store between 20° to 25°C (68° to 77°F)

    Blisters packs:

    • safety sealed: do not use if the individual blister unit imprinted with loratadine is open or torn
    • store between 20° to 25°C (68° to 77°F)
    • protect from excessive moisture
  • INACTIVE INGREDIENTS


    corn starch, lactose monohydrate, magnesium stearate, pregelatinized starch

  • QUESTIONS OR COMMENTS?

    Call 1-888-588-1418

  • HOW SUPPLIED

    Loratadine 10mg Tablet

    • NDC 71335-2391-1: 20 Tablets in a BOTTLE
    • NDC 71335-2391-2: 30 Tablets in a BOTTLE
    • NDC 71335-2391-3: 60 Tablets in a BOTTLE
    • NDC 71335-2391-4: 14 Tablets in a BOTTLE
    • NDC 71335-2391-5: 10 Tablets in a BOTTLE
    • NDC 71335-2391-6: 90 Tablets in a BOTTLE
    • NDC 71335-2391-7: 28 Tablets in a BOTTLE
    • NDC 71335-2391-8: 15 Tablets in a BOTTLE
    • NDC 71335-2391-9: 100 Tablets in a BOTTLE

    Repackaged/Relabeled by:
    Bryant Ranch Prepack, Inc.
    Burbank, CA 91504

  • PRINCIPAL DISPLAY PANEL

    Loratadine 10mg Tablet

    Label
  • INGREDIENTS AND APPEARANCE
    LORATADINE  
    loratadine tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71335-2391(NDC:69230-323)
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    LORATADINE (UNII: 7AJO3BO7QN) (LORATADINE - UNII:7AJO3BO7QN) LORATADINE10 mg
    Inactive Ingredients
    Ingredient NameStrength
    STARCH, CORN (UNII: O8232NY3SJ)  
    LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    Product Characteristics
    Colorwhite (White to Off white) Scoreno score
    ShapeROUNDSize6mm
    FlavorImprint Code H;L20
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:71335-2391-120 in 1 BOTTLE; Type 0: Not a Combination Product06/18/2025
    2NDC:71335-2391-230 in 1 BOTTLE; Type 0: Not a Combination Product06/18/2025
    3NDC:71335-2391-360 in 1 BOTTLE; Type 0: Not a Combination Product06/18/2025
    4NDC:71335-2391-414 in 1 BOTTLE; Type 0: Not a Combination Product06/18/2025
    5NDC:71335-2391-510 in 1 BOTTLE; Type 0: Not a Combination Product06/18/2025
    6NDC:71335-2391-690 in 1 BOTTLE; Type 0: Not a Combination Product06/18/2025
    7NDC:71335-2391-728 in 1 BOTTLE; Type 0: Not a Combination Product06/18/2025
    8NDC:71335-2391-815 in 1 BOTTLE; Type 0: Not a Combination Product06/18/2025
    9NDC:71335-2391-9100 in 1 BOTTLE; Type 0: Not a Combination Product06/18/2025
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA21171807/28/2023
    Labeler - Bryant Ranch Prepack (171714327)
    Registrant - Bryant Ranch Prepack (171714327)
    Establishment
    NameAddressID/FEIBusiness Operations
    Bryant Ranch Prepack171714327REPACK(71335-2391) , RELABEL(71335-2391)
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