Label: LORATADINE tablet

  • NDC Code(s): 62207-787-51, 62207-787-59
  • Packager: Granules India Ltd
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated December 27, 2019

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  • ACTIVE INGREDIENT(S)

    Loratadine 10 mg

  • PURPOSE

    Antihistamine

  • USE(S)

    temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:

     runny nose


     sneezing

     itchy, water eyes

     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.

  • 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

    Tamper-evident: do not use if foil seal under cap, printed with "SEALED for YOUR PROTECTION" is missing, open or broken


    Blister Foil Units

    safety sealed: do not use if the individual blister unit is open or torn

  • STORAGE

    store between 20º to 25ºC (68º to 77ºF)

  • 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

    loratadine-10mg-label-jpg

    loratadine-10mg-blisterlabel-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
    LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
    Product Characteristics
    Colorwhite (White to off white) Scoreno score
    ShapeROUNDSize6mm
    FlavorImprint Code G;10
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:62207-787-5110 in 1 BOTTLE; Type 0: Not a Combination Product01/01/2020
    2NDC:62207-787-5912 in 1 CARTON01/01/2020
    210 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA21072201/01/2020
    Labeler - Granules India Ltd (915000087)
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