Fexofenadine Hcl Tablet, Film Coated
FDA Label NDC 71610-905

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Aphena Pharma Solutions - Tennessee, Llc for the product Fexofenadine Hcl (NDC 71610-905). 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

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

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