Label: LORATADINE tablet

  • NDC Code(s): 16571-822-01, 16571-822-03, 16571-822-30
  • Packager: Rising Pharmaceuticals, Inc
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated March 10, 2022

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  • Drug Facts

  • ACTIVE INGREDIENT

    Active Ingredient (in each tablet)

    Loratadine, 10 mg USP

  • PURPOSE

    Purpose

    Antihistamine

  • Uses

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

    • runny nose
    • sneezing
    • itchy, watery eyes
    • itching of the nose or throat
  • Warnings

    Do not use if you ever have had an allergic reaction to this product or any of its ingredients.

  • ASK DOCTOR

    Ask a doctor before use if you have liver or kidney disease. Your doctor should determine if you need a different dose.

  • WHEN USING

    When using this product do not take more than directed. Taking more than directed may cause drowsiness.

  • STOP USE

    Stop use and ask a doctor if an allergic reaction to this product occurs. Seek medical help right away.

  • PREGNANCY OR BREAST FEEDING

    If pregnanct or breast-feeding, ask a health professional before use.

  • KEEP OUT OF REACH OF CHILDREN

    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 of age 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 between 20° - 25°C (68°-77°F)
  • INACTIVE INGREDIENT

    Inactive ingredients corn starch, lactose monohydrate, magnesium stearate, povidone

  • QUESTIONS

    Questions or comments?

    Call 1-800-874-7464 Monday to Friday 9 AM to 5 PM EST

  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

    30 Count Container Label

    30-Count-Label

    30ctback

    100 Count Container Label

    100-Count-Label

    100ctback

  • INGREDIENTS AND APPEARANCE
    LORATADINE 
    loratadine tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:16571-822
    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)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    povidone (UNII: FZ989GH94E)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    Product Characteristics
    Colorwhite (white to off-white) Scoreno score
    ShapeROUNDSize6mm
    FlavorImprint Code 10;p
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:16571-822-01100 in 1 BOTTLE; Type 0: Not a Combination Product03/10/2022
    2NDC:16571-822-0330 in 1 BOTTLE; Type 0: Not a Combination Product03/10/2022
    3NDC:16571-822-30300 in 1 BOTTLE; Type 0: Not a Combination Product03/10/2022
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA21468403/10/2022
    Labeler - Rising Pharmaceuticals, Inc (835513529)
    Registrant - Unique Pharmaceuticals Laboratories (650434645)
    Establishment
    NameAddressID/FEIBusiness Operations
    Unique Pharmaceuticals Laboratories650434645manufacture(16571-822)
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