Label: ALLERGY RELIEF NON DROWSY- loratadine tablet

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

Drug Label Information

Updated October 15, 2012

If you are a consumer or patient please visit this version.

View All Sections
  • ACTIVE INGREDIENT

    Active Ingredients

    Loratadine USP 10 mg
  • PURPOSE

    Antihistamine

  • DOSAGE & ADMINISTRATION

    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

  • INDICATIONS & USAGE

    Uses: • temporarily relieves these symptoms due to hay fever
    or other upper respiratory allergies: • runny nose • sneezing
    • itchy, watery eyes • itching of the nose or throat

  • WARNINGS

    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 a doctor if: • an allergic reaction
    to this product occurs. Seek medical help right away.
  • PREGNANCY OR BREAST FEEDING

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

  • KEEP OUT OF REACH OF CHILDREN

    KEEP OUT OF REACH OF CHILDREN.

  • INACTIVE INGREDIENT

    Inactive
    ingredients: corn starch, lactose monohydrate,
    magnesium stearate, pregelatinized starch

  • PRINCIPAL DISPLAY PANEL

    MM1

    Allergy Non Drowsy packet

  • INGREDIENTS AND APPEARANCE
    ALLERGY RELIEF NON DROWSY 
    loratadine tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52904-430
    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)  
    LACTOSE (UNII: J2B2A4N98G)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    Product Characteristics
    Colorwhite (snow white) Scoreno score
    ShapeROUND (RX526) Size6mm
    FlavorImprint Code RX526
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:52904-430-011 in 1 PACKET
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA07715310/15/2012
    Labeler - Select Corporation (053805599)
    Registrant - Select Corporation (053805599)
View All Sections

Find additional resources

(also available in the left menu)

Safety

Report Adverse Events, FDA Safety Recalls, Presence in Breast Milk

Related Resources

Medline Plus, Clinical Trials, PubMed, Biochemical Data Summary

More Info on this Drug

View Labeling Archives, RxNorm, Get Label RSS Feed, View NDC Code(s)NEW!