Fexofenadine Hydrochloride Tablet
FDA Label NDC 71309-091

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Safrel Pharmaceuticals, Llc. for the product Fexofenadine Hydrochloride (NDC 71309-091). 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(s), purpose, use(s), warnings, keep out of reach of children, directions, other information, inactive ingredients, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredient(S)

Fexofenadine HCl USP 60 mg (for 60 mg)

Fexofenadine HCl USP 180 mg (for 180 mg)

Purpose

Antihistamine

Use(S)

temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:


  • runny nose
  • itchy, water 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.

    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 one 60 mg tablet with water every 12 hours; do not take more than 2 tablets in 24 hours (for 60 mg)
take one 180 mg tablet with water once a day; do not take more than 1 tablet in 24 hours (for 180 mg) 
 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 foil printed with granules logo under bottle cap is opened or torn.
  • Do not use if carton is opened or if individual blister units are torn or opened.
  • store between 20° and 25°C (68° and 77°F)
  • protect from excessive moisture

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

Contact 1-844-384-3723 Mon-Fri 8:00 AM EST to 5:00 PM PST



Distributed By:

Safrel Pharmaceuticals, LLC
Bridgewater, NJ 08807

Principal Display Panel

NDC 71309-091-01 - 100 Count

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