Label: LORATADINE- loratadine tablet

  • NDC Code(s): 69230-323-01, 69230-323-10, 69230-323-30, 69230-323-31, view more
    69230-323-32, 69230-323-33, 69230-323-34
  • Packager: Camber Consumer Care Inc
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated September 8, 2023

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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

  • PRINCIPAL DISPLAY PANEL

    Loratadine-tablets-USP-10mg-30's-carton

     

    Loratadine-tablets-10mg-30s-carton

    Loratadine-tablets-USP-10mg-30's-container

    Loratadine-tablets-10mg-30s-container

    Loratadine-tablets-USP-10mg-100's-carton

    Loratadine-tablets-10mg-100s-carton

    Loratadine-tablets-USP-10mg-100's-container

    Loratadine-tablets-10mg-100s-container

    Loratadine-tablets-USP-10mg-300's-carton

    Loratadine-tablets-10mg-300s-carton

    Loratadine-tablets-USP-10mg-300's-container

    Loratadine-tablets-10mg-300s-container


  • INGREDIENTS AND APPEARANCE
    LORATADINE  
    loratadine tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)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:69230-323-301 in 1 CARTON07/28/2023
    130 in 1 BOTTLE; Type 0: Not a Combination Product
    2NDC:69230-323-311 in 1 CARTON07/28/2023
    2108 in 1 BOTTLE; Type 0: Not a Combination Product
    3NDC:69230-323-101000 in 1 BOTTLE; Type 0: Not a Combination Product07/28/2023
    4NDC:69230-323-0110 in 1 CARTON07/28/2023
    4NDC:69230-323-3210 in 1 BLISTER PACK; Type 0: Not a Combination Product
    5NDC:69230-323-331 in 1 CARTON07/28/2023
    5100 in 1 BOTTLE; Type 0: Not a Combination Product
    6NDC:69230-323-341 in 1 CARTON07/28/2023
    6300 in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA21171807/28/2023
    Labeler - Camber Consumer Care Inc (079539968)
    Establishment
    NameAddressID/FEIBusiness Operations
    Annora Pharma Private Limited650980746manufacture(69230-323)
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