Fexofenadine Hydrochloride
FDA Label NDC 49035-995

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Wal-mart Stores, Inc for the product Fexofenadine Hydrochloride (NDC 49035-995). 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, ask a doctor before use if, when using this product, stop use and ask doctor if, if pregnant or breast-feeding, 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, 180 mg

Purpose

Antihistamine

Use(S)

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

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 aluminium or magnesium antacids
  • do not take with fruit juices (see Directions)

Stop Use And Ask 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 180 mg 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

  • safety sealed: do not use if carton is opened or if individual blister units are torn or opened
  • store between 200 and 250C (680 and 770F)
  • protect from excessive moisture and light

Inactive Ingredients

anhydrous lactose, colloidal silicon dioxide, corn starch,croscarmellose sodium, hypromellose, lactose monohydrate, polyethylene glycol 400, pregelatinized corn starch, red iron oxide, stearic acid, titanium dioxide, and yellow iron oxide

Questions Or Comments?

call 1-888-287-1915

Principal Display Panel

NDC 49035-995-62

Non-Drowsy
Original Prescription Strength

Fexofenadine HCl Tablets USP,
180 mg/Antihistamine

Allergy Relief

Indoor and Outdoor Allergies
Relief of:

  • Sneezing
  • Runny nose
  • Itchy, watery eyes
  • Itchy nose or throat                                                                    180 mg EACH  15 TABLETS


    • Fexo-180mg (Fexo 180mg)

    Fexo-180mg (Fexo 180mg)

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