FDA Label for Loratadine

View Indications, Usage & Precautions

    1. DRUG FACTS
    2. ACTIVE INGREDIENT (IN EACH TABLET) LORATADINE 10 MG
    3. PURPOSE ANTIHISTAMINE
    4. USESTEMPORARILY RELIEVES THESE SYMPTOMS DUE TO HAY FEVER OR OTHER UPPER RESPIRATORY ALLERGIES: • RUNNY NOSE • ITCHY, WATER EYES • SNEEZING • ITCHING OF THE NOSE OR THROAT
    5. WARNINGSDO NOT USEIF YOU HAVE EVER HAD AN ALLERGIC REACTION TO THIS PRODUCT OR ANY OF ITS INGREDIENTS
    6. ASK A DOCTOR BEFORE USE IF YOU HAVELIVER OR KIDNEY DISEASE. YOUR DOCTOR SHOULD DETERMINE IF YOU NEED A DIFFERENT DOSE.
    7. WHEN USING THIS PRODUCTDO NOT TAKE MORE THAN DIRECTED. TAKING MORE THAN DIRECTED MAY CAUSE DROWSINESS.
    8. STOP USE AND ASK A DOCTORIF AN ALLERGIC REACTION TO THIS PRODUCT OCCURS. SEEK MEDICAL HELP RIGHT AWAY.
    9. IF PREGNANT OR BREAST-FEEDING, ASK A HEALTH PROFESSIONAL BEFORE USE
    10. 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).
    11. 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
    12. OTHER INFORMATION • STORE BETWEEN 20º TO 25ºC (68º TO 77ºF)
    13. INACTIVE INGREDIENTS CORN STARCH, LACTOSE MONOHYDRATE, MAGNESIUM STEARATE, POVIDONE
    14. QUESTIONS OR COMMENTS? 833-358-6431
    15. PACKAGE AND PRINCIPAL DISPLAY

Loratadine Product Label

The following document was submitted to the FDA by the labeler of this product Strategic Sourcing Services, Llc. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

Drug Facts




Active Ingredient (In Each Tablet) Loratadine 10 Mg




Purpose Antihistamine




Usestemporarily Relieves These Symptoms Due To Hay Fever Or Other Upper Respiratory Allergies: • Runny Nose • Itchy, Water Eyes • Sneezing • Itching Of The Nose Or Throat




Warningsdo Not Useif You Have Ever Had An Allergic Reaction To This Product Or Any Of Its Ingredients




Ask A Doctor Before Use If You Haveliver Or Kidney Disease. Your Doctor Should Determine If You Need A Different Dose.




When Using This Productdo Not Take More Than Directed. Taking More Than Directed May Cause Drowsiness.




Stop Use And Ask A Doctorif 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 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 • Store Between 20º To 25ºc (68º To 77ºf)




Inactive Ingredients Corn Starch, Lactose Monohydrate, Magnesium Stearate, Povidone




Questions Or Comments? 833-358-6431




Package And Principal Display




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