Active Ingredient(In Each Tablet)
Fexofenadine HCl USP, 180 mg
Fexofenadine Hydrochloride
FDA Label NDC 53943-021
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Discount Drug Mart for the product Fexofenadine Hydrochloride (NDC 53943-021). 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, do not use, ask a doctor before use if you have, when using this product, stop use and ask doctor if, if pregnant 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 resporatory alleergies:
- 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 aluminium 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.
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.
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
- safety sealed: do not use if carton is opened or 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 and light
Inactive Ingredients
anhydrous lactose, colloidal silicon dioxide, corn starch,croscarmellose sodium, hypromellose, lactose monohydrate, polyethylene glycol 400, pregelatinized corn starch, red iron oxide, steric acid, titanium dioxide, and yellow iron oxide,
Questions Or Comments?
call 1-855-274-4122
Package Label-Principal Display Panel-180Mg ( 30 Tablets Bottle)
NDC 53943-021-09
Original Prescription Strength
Non-Drowsy
Fexofenadine Hydrochloride Tablets USP, 180 mg/antihistamine
Allergy
24 Hours Relief of:
Sneezing
Runny nose
Itchy, watery eyes
Itchy nose or throat
Indoor & Outdoor Allergies
DO NOT USE IF FOIL SEAL IS TORN OR MISSING
30 Tablets 180 mg each
Carton-180 mg-30scount (Fexofenadine Fig1)
Package Label-Principal Display Panel-180Mg ( 45 Tablets Bottle)
NDC 53943-021-17
Original Prescription Strength
Non-Drowsy
Fexofenadine Hydrochloride Tablets USP, 180 mg/antihistamine
Allergy
24 Hours Relief of:
Sneezing
Runny nose
Itchy, watery eyes
Itchy nose or throat
Indoor & Outdoor Allergies
DO NOT USE IF FOIL SEAL IS TORN OR MISSING
45 Tablets 180 mg each
Carton-180mg-45scount (Fexofenadine Fig2)
Package Label-Principal Display Panel-180Mg (15Tablets Blister)
NDC 53943-021-85 Blistor Carton-180 mg-15tablets (Fexofenadine Fig3)
Original Prescription Strength
Non-Drowsy
Fexofenadine Hydrochloride Tablets USP, 180 mg/antihistamine
Allergy
24 Hours Relief of:
Sneezing
Runny nose
Itchy, watery eyes
Itchy nose or throat
Indoor & Outdoor Allergies
DO NOT USE IF FOIL SEAL IS TORN OR MISSING
15 Tablets 180 mg each 
Blistor-5 Tablets (Fexofenadine Fig4)
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