Label: LORATADINE tablet

  • NDC Code(s): 62207-787-49, 62207-787-88
  • Packager: Granules India Limited
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated February 13, 2023

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  • ACTIVE INGREDIENT

    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 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.

  • DIRECTIONS

    adults and children 6 years and over1 tablet daily; not more than 1 tablet in 24 hours
    children under 6 years of ageask a doctor
    consumers with liver or kidney diseaseask 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 between 20° to 25°C (68° to 77°F)
  • INACTIVE INGREDIENTS

    Lactose monohydrate, magnesium stearate, sodium starch glycolate and starch maize pregelatinized

  • QUESTIONS OR COMMENTS

    Contact 1-877-770-3183 Mon-Fri 9:00 AM to 4:30 PM EST

  • PRINCIPAL DISPLAY PANEL

    loratidine-label-jpgloratadine-1000-bulk-jpg.jpg

  • INGREDIENTS AND APPEARANCE
    LORATADINE 
    loratadine tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62207-787
    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)  
    SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
    LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    Product Characteristics
    Colorwhite (White to off white) Scoreno score
    ShapeROUNDSize6mm
    FlavorImprint Code G;10
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:62207-787-491000 in 1 BOTTLE; Type 0: Not a Combination Product01/08/2020
    2NDC:62207-787-885 in 1 BOX03/16/2020
    220000 in 1 POUCH; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA21072201/08/2020
    Labeler - Granules India Limited (915000087)
    Establishment
    NameAddressID/FEIBusiness Operations
    Granules India Limited918609236analysis(62207-787) , manufacture(62207-787)
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