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 Retail Business Services, Llc. 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 180 mg
Purpose
Antihistamine
Uses
temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:
runny nose sneezing itchy, watery eyes itching of the nose or throat
Otc - Do Not Use
Do not use if you have ever had an allergic reaction to this product or any of its ingredients.
Otc - Ask Doctor
Ask a doctor before use if you have kidney disease. Your doctor should determine if you need a
different dose.
Otc - When Using
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)
Otc - Stop Use
Stop use and ask a doctor if an allergic reaction to this product occurs. Seek
medical help right away. You may report side effects to FDA at
1-800-FDA-1088.
Otc - Pregnancy Or Breast Feeding
If pregnant or breast-feeding, ask a health professional before use.
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.
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 Safety Information
Other information safety sealed: do not use 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
Inactive Ingredient
Inactive ingredients colloidal silicone dioxide, croscarmellose sodium, hypromellose,
magnesium stearate, microcrystalline cellulose, polyethylene
glycol/macrogol, povidone, pregelatinized starch, red iron oxide,
silica, titanium dioxide, yellow iron oxide.
Otc - Questions
Questions or comments? call +1-888-333-9792
Principal Display Panel
non-drowsy
FEXOFENADINE
HYDROCHLORIDE
TABLETS USP
180 mg
antihistamine
24 Hour
indoor & outdoor allergy relief
• sneezing • runny nose
• itchy, watery eyes
• itchy nose or throat
* Please review the disclaimer below.