Active Ingredient (In Each Tablet)
For 30 mg:
Fexofenadine HCl, USP 30 mg
For 60 mg:
Fexofenadine HCl, USP 60 mg
For 180 mg:
Fexofenadine HCl, USP 180 mg
Fexofenadine Hydrochloride
FDA Label NDC 62756-543
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Sun Pharmaceutical Industries, Inc. for the product Fexofenadine Hydrochloride (NDC 62756-543). 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, 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 respiratory allergies:
- runny nose
- sneezing
- itchy, watery eyes
- 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 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
For 30mg:
| 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 |
For 60mg:
| adults and children 12 years of age and over | take one 60 mg tablet with water every 12 hours; do not take more than 2 tablets 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 |
For 180mg:
| 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 inner safety seal is open or torn
- store between 20° to 25°C (68° to 77°F)
- protect from excessive moisture
Inactive Ingredients
crospovidone, hypromellose, iron oxide red, iron oxide yellow, magnesium stearate, microcrystalline cellulose, polyethylene glycol, pregelatinized starch, titanium dioxide
Questions?
Call toll free 1-800-818-4555 weekdays
Principal Display Panel
For 30 mg Allergy: 30mg-allergy-2 (30mg Allergy 2) 30mg-allergy-3 (30mg Allergy 3) 30mg-allergy-4 (30mg Allergy 4) 30mg-allergy-5 (30mg Allergy 5) 30mg-allergy-6 (30mg Allergy 6) 30mg-allergy-7 (30mg Allergy 7)
ORIGINAL PRESCRIPTION STRENGTH
NDC 62756-542-88
Children's
Fexofenadine Hydrochloride Tablets, USP
30 mg
ALLERGY
(12 Hour)
Antihistamine
Indoor and Outdoor Allergies
100 Tablets 30 mg each
SUN PHARMA 
For 60 mg Allergy:
NDC 62756-543-88
Fexofenadine Hydrochloride Tablets, USP
60 mg
ALLERGY
(12 Hour)
Antihistamine
Indoor and Outdoor Allergies
100 Tablets 60 mg each
SUN PHARMA
60mg-allergy-1 (60mg Allergy 1)
60mg-allergy-2 (60mg Allergy 2)
60mg-allergy-3 (60mg Allergy 3) 
For 180 mg Allergy:
NDC 62756-545-88
Fexofenadine Hydrochloride Tablets, USP
180 mg
ALLERGY
(24 Hour)
Antihistamine
Indoor and Outdoor Allergies
100 Tablets 180 mg each
SUN PHARMA
180mg-allergy-1 (180mg Allergy 1)
180mg-allergy-2 (180mg Allergy 2)
For 30 mg Allergy: 30mg-allergy-sb (30mg Allergy Sb)
NDC 62756-542-74
ORIGINAL PRESCRIPTION STRENGTH
NON-DROWSY
Children's
Fexofenadine Hydrochloride Tablets, USP
30 mg
ALLERGY
(12 Hour)
Antihistamine
Indoor and Outdoor Allergies
Ages 6 years and Older
Relief of:
- Sneezing
- Runny Nose
- Itchy, Watery Eyes
- Itchy Nose or Throat
5 (1 x 5)Tablets 30 mg each
SUN PHARMA
DO NOT USE IF INDIVIDUAL BLISTER UNIT IS OPEN OR TORN 
For 60 mg Allergy: 60mg-allergy-sb (60mg Allergy Sb)
NDC 62756-543-74
ORIGINAL PRESCRIPTION STRENGTH
NON-DROWSY
Fexofenadine Hydrochloride Tablets, USP
60 mg
ALLERGY
(12 Hour)
Antihistamine
Indoor and Outdoor Allergies
Relief of:
- Sneezing
- Runny Nose
- Itchy, Watery Eyes
- Itchy Nose or Throat
5 (1 x 5)Tablets 60 mg each
SUN PHARMA
DO NOT USE IF INDIVIDUAL BLISTER UNIT IS OPEN OR TORN 
For 180 mg Allergy:
NDC 62756-545-74
ORIGINAL PRESCRIPTION STRENGTH
NON-DROWSY
Fexofenadine Hydrochloride Tablets, USP
180 mg
ALLERGY
(24 Hour)
Antihistamine
Indoor and Outdoor Allergies
Relief of:
- Sneezing
- Runny Nose
- Itchy, Watery Eyes
- Itchy Nose or Throat
5 (1 x 5)Tablets 180 mg each
SUN PHARMA
DO NOT USE IF INDIVIDUAL BLISTER UNIT IS OPEN OR TORN
180mg-allergy-sb (180mg Allergy Sb)
* Please review the disclaimer below.
