Drug Facts
Active ingredient (in each tablet)
Fexofenadine HCl USP, 30 mg
Fexofenadine Hydrochloride Tablet, Film Coated
FDA Label NDC 58602-876
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 58602-876). 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
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 two 30 mg tablets with water every 12 hours; do not take more than 4 tablets in 24 hours |
| children 6 to under 12 years of age | take one 30 mg tablet with water every 12 hours; do not take more than 2 tablets in 24 hours |
| children under 6 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 - 30 Mg (30 Tablets Container Label)
AUROHEALTH
NDC 58602-876-09
NON-DROWSY
Children's
Fexofenadine Hydrochloride
Tablets USP, 30 mg
Antihistamine
Allergy
Ages 6 Years and Older
INDOOR/OUTDOOR ALLERGY RELIEF
√ Sneezing
√ Runny Nose
√ Itchy, Watery Eyes
√ Itchy Nose or Throat
12 Hour
30 TABLETS
Package Label-principal Display Panel -30 mg (30 Tablets Container Label) (Fexofenadine Fig1)
Package Label-Principal Display Panel - 30 Mg (30 Tablets Container Carton Label)
AUROHEALTH
NDC 58602-876-09
*Compare to Children's Allegra®
Allergy active ingredient
NON-DROWSY
Children's
Fexofenadine
Hydrochloride
Tablets USP, 30 mg
Antihistamine
Allergy
12 Hour
Ages 6 Years and Older
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 -30 mg (30 Tablets Container Carton Label) (Fexofenadine Fig2)
Package Label-Principal Display Panel - 30 Mg Blister Carton (1 X 5 Unit-Dose)
AUROHEALTH
NDC 58602-876-60
Package Label-principal Display Panel (30 mg Blister Carton (1 x 5 Unit-dose))
*Compare to Children’s Allegra®
Allergy active ingredient
NON-DROWSY
Children's
Fexofenadine Hydrochloride
Tablets USP, 30 mg
Antihistamine
Allergy
12 Hour
Ages 6 Years and Older
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 
* Please review the disclaimer below.
