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  5. Label Information: Guardian Loratadine

FDA Label for Guardian Loratadine

View Indications, Usage & Precautions

Table of Contents

    1. ACTIVE INGREDIENT (IN EACH TABLET)
    2. PURPOSE
    3. USE(S)
    4. WARNINGS
    5. DO NOT USE
    6. ASK A DOCTOR BEFORE USE IF YOU HAVE
    7. WHEN USING THIS PRODUCT
    8. STOP USE AND ASK DOCTOR IF
    9. IF PREGNANT OR BREASTFEEDING,
    10. KEEP OUT OF REACH OF CHILDREN
    11. DIRECTIONS
    12. OTHER INFORMATION
    13. INACTIVE INGREDIENTS
    14. QUESTIONS OR COMMENTS?
    15. PRINCIPAL DISPLAY PANEL

Guardian Loratadine Product Label

The following document was submitted to the FDA by the labeler of this product Guardian Drug Company. 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 (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 doctor





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 PROTECTION" IS OPEN OR TORN 


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
Runny Nose
Itchy, Watery Eyes
Itchy Throat Or Nose



285 - 285

285 - 285



* Please review the disclaimer below.