Fexofenadine Hydrochloride Tablet
FDA Label NDC 62207-623

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Granules India Limited for the product Fexofenadine Hydrochloride (NDC 62207-623). 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, 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

Active Ingredient (In Each Tablet)

Fexofenadine HCl USP, 180 mg

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

  • 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.

Directions

adults and children 12 years of age and overtake one 180 mg tablet with water once a day; do not take more than 1 tablet in 24 hours
children under 12 years of agedo not use
adults 65 years of age and olderask a doctor
consumers with kidney diseaseask a doctor

Other Information

  • safety sealed: do not use if carton is opened or if individual blister units are torn or opened
  • store between 20° and 25°C (68° and 77°F)
  • protect from excessive moisture

Inactive Ingredients

ammonium hydroxide, colloidal silicon dioxide, croscarmellose sodium, D & C Red 33, ferrosoferric oxide, FD & C blue 1, FD & C yellow 6, gelatin, hydroxypropyl cellulose, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, pregelatinized starch, propylene glycol, shellac, titanium dioxide.

Questions Or Comments?

Contact 1-877-770-3183 Mon-Fri 8:00 AM EST to 5:00 PM PST.

Manufactured By:
Granules India Limited
Hyderabad-500 081, India

MADE IN INDIA

Distributed By:
Granules USA, Inc.
Parsippany, NJ 07054

Principal Display Panel 180 Mg - 24S Container Label

NDC 62207-623-41

NON-DROWSY

Fexofenadine HCl

Tablets USP, 180 mg

Allergy

Antihistamine

INDOOR / OUTDOOR ALLERGY
RELIEF 24HR

  • Sneezing
  • Runny Nose
  • Itchy, Watery Eyes
  • Itchy Nose or Throat

    • 24 GELCAPS

    Gel Coated Tablets

    *Compare to the active ingredient in

    Allegra ® Allergy 24 HOUR

    Fexo-container-label (62207 623 41)

    Fexo-container-label (62207 623 41)

Principal Display Panel 180 Mg -24S Container Carton

NDC 62207-623-41
NON-DROWSY


Fexofenadine HCl
Tablets, USP

180 mg

Allergy

Antihistamine
INDOOR / OUTDOOR ALLERGY
RELIEF 24 HR

  • Sneezing
  • Runny Nose
  • Itchy, Watery Eyes
  • Itchy Nose or Throat

    • 24 GELCAPS
    Gel Coated Tablets

    *Compare to the active ingredient in Allegra ®

    Allergy 24 HOUR


    Fexo-container-carton (62207 623 41 Contnr Carton)

    Fexo-container-carton (62207 623 41 Contnr Carton)

Principal Display Panel 180 Mg - Blister Carton

NDC 62207-623-71
NON-DROWSY


Fexofenadine HCl Tablets USP, 180 mg

Allergy


Antihistamine


INDOOR / OUTDOOR ALLERGY
RELIEF 24 HR

  • Sneezing
  • Runny Nose
  • Itchy, Watery Eyes
  • Itchy Nose or Throat

    • 70 (7x10) GELCAPS

    Gel Coated Tablets


    *Compare to the active ingredient in ALLEGRA ® ALLERGY 24 HOUR

    Fexo-blister-carton (Fexo Blister Carton)

    Fexo-blister-carton (Fexo Blister Carton)

* Please review the disclaimer below.