FDA Label for Fexofenadine Hydrochloride
View Indications, Usage & Precautions
Fexofenadine Hydrochloride Product Label
The following document was submitted to the FDA by the labeler of this product Physicians Total Care, Inc.. 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(S)
Fexofenadine HCl USP, 180 mg
Purpose
Antihistamine
Use(S)
temporarily relieves these symptoms due to hay fever or otherupper respiratory allergies:
- runny nose
- itchy, watery eys
- sneezing
- itching of the nose or Throad
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 doctorshould 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 Doctor If
Allergy
an allergic reaction to this product occurs. Seek medical help right away.
Pregnancy/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 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 individual blister units are torn or opened.
Storage
store between 20° - 25°C (68° - 77°F)
protect from excessive moisture
Inactive Ingredients
colloidal silicon dioxide, corn starch, croscarmellose sodium, magnesium stearate, mannitol, and powdered cellulose, opadry pink 03B54504 containing FD&C Red no. 40, hypromellose, iron oxide black, polyethylene glycol and titanium dioxide.
Questions
call toll-free 1-888-375-3784
Manufactured by:
Dr. Reddy’s Laboratories Louisiana LLC,
8800 Line Ave Shreveport, LA, 71106.
OR
Manufactured by:
Dr. Reddy’s Laboratories Limited
Bachepalli - 502 325 INDIA
Other
Additional barcode labeling by:
Physicians Total Care, Inc.
Tulsa, OK 74146
Principal Display Panel
Fexofenadine HCl USP, 180 mg
NDC 54868-6289-0
* Please review the disclaimer below.