Label: LORATADINE- loratadine tablet

  • NDC Code(s): 69230-328-01, 69230-328-03
  • Packager: Camber Consumer Care Inc
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated December 6, 2022

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

View All Sections
  • 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 - 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.
  • 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.
  • IF PREGNANT OR BREAST-FEEDING
    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. (1-800-222-1222)
  • DIRECTIONS
    adults and children 6 years and over1 tablet daily; not more than 1 tablet in 24 hours - children under 6 years of ageask a doctor - consumers with liver or kidney diseaseask a ...
  • OTHER INFORMATION
    Tamper-evident: do not use if foil seal under cap, printed with "SEALED for YOUR PROTECTION" is missing, open or broken
  • STORAGE
    store between 20° to 25°C (68° to 77°F)
  • INACTIVE INGREDIENTS
    Lactose monohydrate, magnesium stearate, sodium starch glycolate and starch maize pregelatinized
  • QUESTIONS OR COMMENTS
    Contact 1-888-588-1418 Mon-Fri 8:00 AM EST to 5:00 PM EST
  • PRINCIPAL DISPLAY PANEL
    Loratadine 10 mg 100-count Carton Label -    Loratadine 10 mg 100-count Container Label - Loratadine 10 mg 300-count Container Label
  • 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!