FDA Label for Fexofenadine Hcl
View Indications, Usage & Precautions
- ACTIVE INGREDIENT (IN EACH FILM-COATED TABLET)
- PURPOSE
- USES
- DO NOT USE
- ASK A DOCTOR BEFORE USE IF YOU HAVE
- WHEN USING THIS PRODUCT
- STOP USE AND ASK A DOCTOR IF
- IF PREGNANT OR BREAST-FEEDING,
- KEEP OUT OF REACH OF CHILDREN.
- DIRECTIONS
- OTHER INFORMATION
- INACTIVE INGREDIENTS
- QUESTIONS OR COMMENTS?
- PRINCIPAL DISPLAY PANEL
- PRODUCT LABEL
Fexofenadine Hcl Product Label
The following document was submitted to the FDA by the labeler of this product Quality Choice (chain Drug Marketing Association). 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 Film-Coated Tablet)
Fexofenadine HCl USP 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 If 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,
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 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
- each tablet contains: sodium 8 mg
- store between 20-25°C (68-77°F)
- protect from excessive moisture
- this product meets the requirements of USP Dissolution Test 2
Inactive Ingredients
anhydrous lactose,colloidal silicon dioxide, corn starch, croscarmellose sodium, lactose monohydrate, pregelatinized starch (maize), stearic acid, opadry pink 03B84893 containing hypromellose, polyethylene glycol, red iron oxide, titanium dioxide, and yellow iron oxide
Questions Or Comments?
call 1-248-449-9300 Monday- Friday 9AM- 5PM EST
Principal Display Panel
†Compare to the active ingredient in Allegra® Allergy 24 hour*
ORIGINAL PRESCRIPTION STRENGTH
Fexofenadine hydrochloride
tablets USP, 180 mg / Antihistamine
Indoor and outdoor allergies
Non-Drowsy
24 Hour Relief of:
sneezing
runny nose
itchy, watery eyes
itchy nose or throat
Tablets
†This product is not manufactured or distributed by Chattem Inc., distributor of Allegra® Allergy 24 hour
KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.
TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING.
Distributed by C.D.M.A., Inc.©
43157 W. Nine Mile
Novi, MI 48376-0995
Product Label
Quality Choice Fexofenadine Hydrochloride Tablets USP, 180 mg
* Please review the disclaimer below.