Active Ingredient (In Each Tablet)
Fexofenadine HCl 180 mg
Kirkland Signature Aller Fex Tablet, Film Coated
FDA Label NDC 63981-847
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Costco Wholesale Company for the product Kirkland Signature Aller Fex (NDC 63981-847). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding active ingredient (in each tablet), purpose, uses, do not use, ask a doctor before use is you have, when using this product, stop use and ask a doctor if, if pregnant or breast-feeding,, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
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
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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)
* Please review the disclaimer below.
