FDA Label for Fexofenadine Hydrochloride
View Indications, Usage & Precautions
- ACTIVE INGREDIENT(IN EACH TABLET)
- PURPOSE
- USES
- WARNINGS
- DO NOT USE
- ASK A DOCTOR BEFORE USE IF YOU HAVE
- WHEN USING THIS PRODUCT
- STOP USE AND ASK DOCTOR IF
- IF PREGNANT OR BREAST-FEEDING
- KEEP OUT OF REACH OF CHILDREN
- DIRECTIONS
- OTHER INFORMATION
- INACTIVE INGREDIENTS
- QUESTIONS OR COMMENTS?
- PRINCIPAL DISPLAY PANEL- 60 MG 24 CT
- PRINCIPAL DISPLAY PANEL- 180 MG 15 CT
Fexofenadine Hydrochloride Product Label
The following document was submitted to the FDA by the labeler of this product Walgreen Co. 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 USP, 180 mg
Fexofenadine HCl USP, 60 mg
Purpose
Antihistamine
Uses
temporarily relieves these symptoms due to hay fever or other upper resporatory 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
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 aluminium or magnesium antacids
- do not take with fruit juices (see directions)
Stop Use And Ask 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 |
| 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
- safety sealed: do not use if carton is opened or if printed foil inner seal on bottle is torn or opened
- store between 20°and 25°C (68°and 77°F)
- protect from excessive moisture and light
Inactive Ingredients
anhydrous lactose, colloidal silicon dioxide, corn starch,croscarmellose sodium, hypromellose, lactose monohydrate, polyethylene glycol 400, pregelatinized corn starch, red iron oxide, steric acid, titanium dioxide, and yellow iron oxide,
Questions Or Comments?
call 1-855-274-4122
Principal Display Panel- 60 Mg 24 Ct
NDC 0363-0095-24
NON-DROWSY ORIGINAL PRESCRIPTION STRENGTH
Wal-Fex
12 HOUR ALLERGY
Fexofenadine Hydrochloride Tablets USP, 60 mg/antihistamine
12 Hour, TABLETS
INDOOR & OUTDOOR ALLERGIES
Relief of Sneezing;Runny nose; Itchy, Watery Eyes & Itchy Nose or Throat
24 Tablets 60 mg each
Principal Display Panel- 180 Mg 15 Ct
NDC 0363-0097-53
NON-DROWSY ORIGINAL PRESCRIPTION STRENGTH
Wal-Fex
Fexofenadine Hydrochloride Tablets USP, 180 mg/antihistamine
24 Hour, TABLETS
INDOOR & OUTDOOR ALLERGIES
Relief of Sneezing;Runny nose; Itchy, Watery Eyes & Itchy Nose or Throat
15 Tablets 180 mg each
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