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  5. Label Information: Loratadine

FDA Label for Loratadine

View Indications, Usage & Precautions

Table of Contents

    1. ACTIVE INGREDIENT(S)
    2. PURPOSE
    3. USE(S)
    4. WARNINGS
    5. ASK A DOCTOR BEFORE USE IF
    6. WHEN USING THIS PRODUCT
    7. STOP USE AND ASK A DOCTOR IF
    8. IF PREGNANT OR BREAST-FEEDING
    9. KEEP OUT OF REACH OF CHILDREN
    10. DIRECTIONS
    11. OTHER INFORMATION
    12. STORAGE
    13. INACTIVE INGREDIENTS
    14. QUESTIONS OR COMMENTS
    15. PRINCIPAL DISPLAY PANEL

Loratadine Product Label

The following document was submitted to the FDA by the labeler of this product Camber Consumer Care Inc. 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.

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 doctor


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

carton-label - loratadine 100s carton label

carton-label - loratadine 100s carton label

  

Loratadine 10 mg 100-count Container Label


Loratadine 10 mg 300-count Container Label


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