FDA Label for Fexofenadine Hcl

View Indications, Usage & Precautions

Fexofenadine Hcl Product Label

The following document was submitted to the FDA by the labeler of this product Radha Pharmaceuticals. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

Allergy Active Ingredient (In Each Film-Coated Tablet)



Fexofenadine HCl USP 60 mg
Fexofenadine HCl USP 180 mg


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 *

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

Allergy Relief

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

500 Tablets

Allergy Relief

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

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

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


* Please review the disclaimer below.