Allergy Active Ingredient (In Each Film-Coated Tablet)
Fexofenadine HCl USP 60 mg
Fexofenadine HCl USP 180 mg
Fexofenadine Hcl Tablet, Film Coated
FDA Label NDC 77771-202
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Radha Pharmaceuticals for the product Fexofenadine Hcl (NDC 77771-202). 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 allergy active ingredient (in each film-coated tablet), purpose, uses, do not use, 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
- 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 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.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children.
In case of overdose, get medical help or contact a Poison Control Center right away.
Directions
Directions (for 60mg)
adults and children 12 years of age and over | take one 60mg 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 |
Directions (for 180mg)
adults and children 12 years of age and over | take one 180mg 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
- store between 20° and 25°C (68° and 77°F)
- protect from excessive moisture
- each tablet contains:sodium 2.7 mg (for 60 mg), sodium 8.2 mg (for 180 mg)
- this product meets the requirements of USP Dissolution Test 2
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
Otc - Questions
Questions or comments?
Call toll-free
1-855-724-3436
Distributed by:
Radha Pharmaceuticals Inc
Hauppauge, NY 11788 USA
Package/Label Principal Display Panel
Radha Pharmaceuticals Inc
NDC 77771-201-01
Compare to the
active ingredient in
Allegra
®Allergy
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Non-Drowsy
Fexofenadine Hydrochloride
Tablets, USP
60 mg
Antihistamine
12-Hour
Indoor/Outdoor Allergy Relief
◾ Sneezing ◾ Runny Nose
◾ Itchy, Watery Eyes ◾ Itchy Nose or Throat
100 Tablets
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Fexofenadine-allergy-60mg-100s (Fexofenadine Allergy 60mg 100s)
Radha Pharmaceuticals Inc
NDC 77771-201-05
Compare to the
active ingredient in
Allegra
®Allergy
*
Non-Drowsy
Fexofenadine Hydrochloride
Tablets, USP
60 mg
Antihistamine
12-Hour
Indoor/Outdoor Allergy Relief
◾ Sneezing ◾ Runny Nose
◾ Itchy, Watery Eyes ◾ Itchy Nose or Throat
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Fexofenadine-allergy-60mg-500s (Fexofenadine Allergy 60mg 500s)
Radha Pharmaceuticals Inc
NDC 77771-202-30
Compare to
the active ingredient in
Allegra
®Allergy
*
Non-Drowsy
Fexofenadine
Hydrochloride
Tablets, USP
180 mg
Antihistamine
24-Hour
Indoor/Outdoor Allergy Relief
◾ Sneezing ◾ Runny Nose
◾ Itchy, Watery Eyes ◾ Itchy Nose or Throat
30 Tablets
Allergy Relief
Fexofenadine-allergy-180mg-30s (Fexofenadine Allergy 180mg 30s)
Radha Pharmaceuticals Inc
NDC 77771-202-01
Compare to the active
ingredient in Allegra
®
Allergy 24 Hour Tablets
*
Non-Drowsy
Fexofenadine Hydrochloride
Tablets, USP
180 mg
Antihistamine
24-Hour
Indoor/Outdoor Allergy Relief
◾ Sneezing ◾ Runny Nose
◾ Itchy, Watery Eyes ◾ Itchy Nose or Throat
100 Tablets
Allergy Relief
Fexofenadine-allergy-180mg-100s (Fexofenadine Allergy 180mg 100s)
Radha Pharmaceuticals Inc
NDC 77771-202-05
Compare to the active
ingredient in Allegra
®
Allergy 24 Hour Tablets
*
Non-Drowsy
Fexofenadine Hydrochloride
Tablets, USP
180 mg
Antihistamine
24-Hour
Indoor/Outdoor Allergy Relief
◾ Sneezing ◾ Runny Nose
◾ Itchy, Watery Eyes ◾ Itchy Nose or Throat
500 Tablets
Allergy Relief
Fexofenadine-allergy-180mg-500s (Fexofenadine Allergy 180mg 500s)
* Please review the disclaimer below.
