Active Ingredient (In Each Caplet)
Fexofenadine HCl 180 mg
Fexofenadine Hydrochloride Tablet
FDA Label NDC 84324-008
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Nuvicare Llc for the product Fexofenadine Hydrochloride (NDC 84324-008). 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 active ingredient (in each caplet), purpose, uses, otc - do not use, otc - ask doctor, otc - when using, otc - stop use, otc - pregnancy or breast feeding, 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
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.
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 (1-800-222-1222) 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 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
Call 1(718) 337-8733 or visit: [email protected]
This Product Is Not Manufactured Or Distributed By Chattem, Inc, A Sanofi Company, Owner Of The Registered Trademark Allegra®.
* Please review the disclaimer below.
