FDA Label for Fexofenadine Hcl
View Indications, Usage & Precautions
Fexofenadine Hcl Product Label
The following document was submitted to the FDA by the labeler of this product H.j. Harkins Company, 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.
Otc - Active Ingredient
Fexofenadine HCl USP, 180 mg
Otc - Purpose
Antihistamine
Dosage & Administration
adults and children 12 years of age and over | take one 180mg 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 |
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 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.
Other Safety Information
- safety sealed: do not use if carton is opened or if printed foil inner seal on bottle is torn or missing
- store between 20° and 25°C (68° and 77°F)
- protect from excessive moisture
- each tablet contains: sodium 8.2 mg
- this product meets the requirements of USP Dissolution Test 2
Inactive Ingredient
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.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children.
In case of overdose, get medical help or contact a Poison Control Center right away.
Indications & Usage
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
* Please review the disclaimer below.