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 Hetero Labs Limited. 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)
(in each tablet)
Fexofenadine Hydrochloride USP, 30 mg
Fexofenadine Hydrochloride USP, 60 mg
Fexofenadine Hydrochloride USP, 180 mg
Purpose
Antihistamine
Use(S)
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
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 Doctor If
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
30 mg
| adults and children 12 years of age and over | take two 30 mg tablets with water every 12 hours; do not take more than 4 tablets in 24 hours |
| children 6 to under 12 years of age | take one 30 mg tablet with water every 12 hours; do not take more than 2 tablets in 24 hours |
| children under 6 years of age | do not use |
| adults 65 years of age and older | ask a doctor |
| consumers with kidney disease | ask a doctor |
60 mg
| adults and children 12 years of age and over | take one 60 mg tablet with water every 12 hours; do not take more than 2 tablets 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 |
180 mg
| 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
- Tamper Evident: Do not use if printed foil seal under cap is missing
- This unit-dose package is not child-resistant
- store between 20° and 25°C (68° and 77°F)
- protect from excessive moisture
Inactive Ingredients
Colloidal silicon dioxide, hypromellose, light liquid paraffin, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, pregelatinized starch, red iron oxide, sodium starch glycolate, talc, titanium dioxide and yellow iron oxide.
Questions?
Call 1-866-495-1995
Principal Display Panel
Fexofenadine Hydrochloride Tablets USP, 30 mg - Container Carton
Fexofenadine Hydrochloride Tablets USP, 30 mg - Container Label
Fexofenadine Hydrochloride Tablets USP, 30 mg - Blister Foil
Fexofenadine Hydrochloride Tablets USP, 30 mg - Blister Carton
Fexofenadine Hydrochloride Tablets USP, 60 mg - Container Carton
Fexofenadine Hydrochloride Tablets USP, 60 mg - Container Label
Fexofenadine Hydrochloride Tablets USP, 60 mg - Blister Foil
Fexofenadine Hydrochloride Tablets USP, 60 mg - Blister Carton
Fexofenadine Hydrochloride Tablets USP, 180 mg - Container Carton
Fexofenadine Hydrochloride Tablets USP, 180 mg - Container Label
Fexofenadine Hydrochloride Tablets USP, 180 mg - Blister Foil
Fexofenadine Hydrochloride Tablets USP, 180 mg - Blister Carton
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