Fexofenadine Hydrochloride Tablet, Film Coated
FDA Label NDC 58602-878

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Aurohealth Llc for the product Fexofenadine Hydrochloride (NDC 58602-878). 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, purpose, uses, warnings, ask a doctor before use if you have, when using this product, stop use and ask a doctor if, 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

Drug Facts

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.


Otc - Pregnancy Or Breast Feeding

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, pregelatinized starch (maize), red iron oxide, stearic acid, titanium dioxide, and yellow iron oxide


Questions Or Comments?

call 1-855-274-4122 (Monday - Friday 8:30 AM to 5:00 PM EST)

Distributed by:
AUROHEALTH LLC
279 Princeton-Hightstown Road
East Windsor, NJ 08520

Made in India

Package Label-Principal Display Panel - 180 Mg (30 Tablets Container Label)

AUROHEALTH

NDC 58602-878-09

NON-DROWSY
Fexofenadine Hydrochloride
Tablets USP, 180 mg
Antihistamine
Allergy

INDOOR / OUTDOOR ALLERGY RELIEF
√ Sneezing
√ Runny Nose
√ Itchy, Watery Eyes
√ Itchy Nose or Throat

24 Hour
30 TABLETS

Package Label-principal Display Panel (180 mg (30 Tablets Container Label))

Package Label-principal Display Panel (180 mg (30 Tablets Container Label))

Package Label-Principal Display Panel - 180 Mg (30 Tablets Container Carton Label)

AUROHEALTH

NDC 58602-878-09

*Compare to 24 Hour Allegra®
Allergy active ingredient

NON-DROWSY
Fexofenadine
Hydrochloride
Tablets USP, 180 mg
Antihistamine
Allergy
24 Hour

INDOOR / OUTDOOR ALLERGY RELIEF
√ Sneezing
√ Runny Nose
√ Itchy, Watery Eyes
√ Itchy Nose or Throat

DO NOT USE IF FOIL SEAL
IS TORN OR MISSING

30 TABLETS

Package Label-principal Display Panel (180 mg (30 Tablets Container Carton Label))

Package Label-principal Display Panel (180 mg (30 Tablets Container Carton Label))

Package Label-Principal Display Panel - 180 Mg Blister Carton (1 X 5 Unit-Dose)

AUROHEALTH

NDC 58602-878-60

*Compare to 24 Hour Allegra®
Allergy active ingredient

NON-DROWSY
Fexofenadine Hydrochloride
Tablets USP, 180 mg
Antihistamine
Allergy

24 Hour

INDOOR / OUTDOOR ALLERGY RELIEF
√ Sneezing
√ Runny Nose
√ Itchy, Watery Eyes
√ Itchy Nose or Throat

DO NOT USE IF BLISTER UNITS
ARE BROKEN OR TORN

5 TABLETS

Package Label-principal Display Panel (180 mg Blister Carton (1 x 5 Unit-dose))

Package Label-principal Display Panel (180 mg Blister Carton (1 x 5 Unit-dose))

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