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  5. Label Information: Kirkland Signature Aller Fex

FDA Label for Kirkland Signature Aller Fex

View Indications, Usage & Precautions

Table of Contents

    1. ACTIVE INGREDIENT (IN EACH TABLET)
    2. PURPOSE
    3. USES
    4. DO NOT USE
    5. ASK A DOCTOR BEFORE USE IS YOU HAVE
    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. INACTIVE INGREDIENTS
    13. QUESTIONS OR COMMENTS?
    14. PACKAGE/LABEL PRINCIPAL DISPLAY PANEL

Kirkland Signature Aller Fex Product Label

The following document was submitted to the FDA by the labeler of this product Costco Wholesale 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)



Fexofenadine HCl 180 mg


Purpose



Antihistamine


Uses



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

Do Not Use



if you have ever had an allergic reaction to this product or any of its ingredients.


Ask A Doctor Before Use Is You Have



kidney disease. Your doctor should determine if you need a different dose.


When Using This Product



  • •do not take more than directed
  • •do not take at the same time as aluminum or magnesium antacids
  • •do not take with fruit juices (see Directions)

Stop Use And Ask A Doctor If



an allergic reaction to this product occurs. Seek medical help right away.


If Pregnant Or Breast-Feeding,



as a health professional before use.


Keep Out Of Reach Of Children.



In case of overdoes, get medial help or contact a Poison Control Center right away (1-800-222-1222).


Directions



adults and children 12 years of age and over

take one 180 mg tablet with water once a day; do not take more than 1 tablet in 24 hours

children under 12 years of age

do not use

adults 65 years of age and older

ask a doctor

consumers with kidney disease

ask a doctor


Other Information



  • •do not use if package is opened or printed foil under cap is broken or missing
  • •store between 20°-25°C (68°-77°F)
  • •protect from excessive moisture
  • •this product meets the requirements of USP Dissolution Test 2

Inactive Ingredients



colloidal silicone dioxide, croscarmellose sodium, FD&C blue #2 aluminum lake, FD&C red #40 aluminum lake, FD&C yellow #6 aluminum lake, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, pregelatinized starch, talc, titanium dioxide


Questions Or Comments?



1-800-719-9260


Package/Label Principal Display Panel



COMPARE TO ALLEGRA® ALLERGY active ingredient*

ALLERGY

ALLER-FEX®

Fexofenadine Hydrochloride Tablets, 180mg

Antihistamine

24 HR

Indoor/Outdoor Allergy Relief

- Sneezing – Runny Nose

- Itchy, Watery Eyes

- Itchy Nose or Throat

NON-DROWSY

Actual Size

180 Tablets 180 mg each

*This product is not manufactured or distributed by Chattem, Inc., a Sanofi Company, distributor of Allegra® Allergy.

aller fex image - image 01

aller fex image - image 01


* Please review the disclaimer below.