Fexofenadine Hydrochloride
FDA Label NDC 66336-560

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Dispensing Solutions, Inc. for the product Fexofenadine Hydrochloride (NDC 66336-560). 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, 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 (In Each Tablet)

Fexofenadine HCl 60 mg

Purpose

Antihistamine

Uses

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

  • runny nose
  • itchy, watery 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

Keep Out Of Reach Of Children.

In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222)

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
children under 12 years of age
do not use
adults 65 years of age and older
ask a doctor

Other Information

  • do not use if printed foil under cap is broken or missing
  • store at 20°-25°C (68°-77°F)
  • protect from excessive moisture
  • this product meets the requirements of USP Dissolution Test 3

Inactive Ingredients

colloidal silicon dioxide, croscarmellose sodium, hypromellose, iron oxide black, iron oxide red, iron oxide yellow, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, titanium dioxide

Otc - Questions

1-800-719-9260

Package/Label Principal Display Panel

NDC 66336-0560-XX
NDC 66336-0560-14
NDC 66336-0560-30


Compare to Allegra® Allergy active ingredient

Fexofenadine Hydrochloride Tablets, 60 mg

Antihistamine

Non-Drowsy

Relief of:

Sneezing

Runny Nose

Itchy, Watery Eyes

Itchy Nose or Throat

Original Prescription Strength

12 Hour

60 mg Each

Actual Size

Indoor and Outdoor Allergies

Allergy


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