Drug Facts Active Ingredient (In Each Tablet)
Fexofenadine HCl 180 mg
Fexofenadine Hcl 180 Mg Tablet
FDA Label NDC 85786-204
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Farmacias De Similares Tx Llc for the product Fexofenadine Hcl 180 Mg (NDC 85786-204). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding drug facts 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 a doctor if, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
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
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.
Keep Out Of Reach Of Children.
In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222).
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
■ store between 20-25°C (68-77°F)
■ protect from excessive moisture
■ retain carton for complete product information and warnings
Inactive Ingredients
colloidal silicon dioxide, croscarmellose sodium, hypromellose, iron oxide black, iron oxide red, iron oxide yellow, lactose monohydrate, macrogol, magnesium stearate, microcrystalline cellulose, pregelatinized starch, titanium dioxide
Questions Or Comments?
855-280-1079
Principal Display Panel
NDC: 85786-204-30
DR. SIMI
Non-Drowsy
Allergy Relief
Fexofenadine HCl Tablets, 180 mg
Antihistamine
Indoor / Outdoor Allergy Relief ■ Sneezing ■ Runny Nose ■ Itchy, Watery Eyes ■ Itchy Nose or Throat
24 Hour
30 TABLETS
†Compare to the active ingredient in Allegra® 24 Hour
†This product is not manufactured or distributed by Chattem, Inc., distributor of Allegra® 24 Hour.
Made in India
Distributed by:
FARMACIAS DE SIMILARES TX LLC
800 Brazos St Ste 260, Austin, TX, 78701, USA
[email protected]
www.drsimi.com
* Please review the disclaimer below.
