Label: GUARDIAN LORATADINE- loratadine tablet

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

Drug Label Information

Updated July 22, 2019

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

View All Sections
  • ACTIVE INGREDIENT (in each tablet)
    Loratadine USP, 10mg
  • PURPOSE
    Antihistamine
  • USE(S)
    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
    .
  • 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 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 over1 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 ...
  • OTHER INFORMATION
    Store at 20o to 25oC (68o to 77oF) [See USP Controlled Room Temperature] Protect from excessive moisture - SAFETY SEALED: DO NOT USE IF THE IMPRINTED BOTTLE SEAL WITH "SEALED FOR YOUR ...
  • INACTIVE INGREDIENTS
    colloidal silicon dioxide, croscarmellose sodium, lactose monohydrate, magnesium stearate
  • QUESTIONS OR COMMENTS?
    call 1-609-860-2600 Hours: 8am-4pm, EST.
  • PRINCIPAL DISPLAY PANEL
    Guardian - NDC 53041-285-21 - Non-Drowsy* Original Prescription Strength - Loratadine - Tablets, USP 10 mg - Antihistamine - Indoor & Outdoor Allergies - 24 Hour Relief of: Sneezing ...
  • INGREDIENTS AND APPEARANCE
    Product Information
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!