Active Ingredient (In Each Tablet)
Fexofenadine HCl 180 mg
Fexofenadine Hydrochloride
FDA Label NDC 66336-561
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Dispensing Solutions, Inc. for the product Fexofenadine Hydrochloride (NDC 66336-561). 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 tablet), purpose, uses, warnings, keep out of reach of children., directions, other information, inactive ingredients, 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
- itchy, watery eyes
- sneezing
- 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
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
- do not use if blister unit is broken or torn (Use for Blister Configurations Only)
- do not use if printed foil under cap is broken or missing (Use for Bottle Configurations Only)
- store at 20°-25°C (68°-77°F)
- protect from excessive moisture
- this product meets the requirements of USP Dissolution Test 3
Inactive Ingredients
colloidal silicon dioxide, croscarmellose sodium, hypromellose, iron oxide black, iron oxide red, iron oxide yellow, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, titanium dioxide
Questions Or Comments?
1-800-719-9260
Package/Label Principal Display Panel
NDC 66336-0561-XX
NDC 66336-0561-30
COMPARE TO active ingredient of ALLEGRA® ALLERGY TABLETS
Original Prescription Strength
FEXOFENADINE HYDROCHLORIDE TABLETS, 180 mg
Antihistamine
ALLERGY
Relief of:
Sneezing
Runny Nose
Itchy, Watery Eyes
Itchy Nose or Throat
Indoor and Outdoor Allergies
24 HOUR
Non-Drowsy
actual size
180 mg EACH
* Please review the disclaimer below.
