Fexofenadine Hydrochloride And Pseudoephedrine Hydrochloride Tablet, Film Coated, Extended Release
FDA Label NDC 46122-452

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Amerisource Bergen for the product Fexofenadine Hydrochloride And Pseudoephedrine Hydrochloride (NDC 46122-452). 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, uses, warnings, do not use, ask a doctor before use if you have, when using this product, stop use and ask doctor if, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredient(S)


(in each extended-release tablet)
Fexofenadine HCl, USP 60 mg
Pseudoephedrine HCl, USP 120 mg

Purpose


Antihistamine
Nasal Decongestant

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
    • temporarily relieves nasal congestion due to the common cold, hay fever or other upper respiratory allergies
    • reduces swelling of nasal passages
    • temporarily relieves sinus congestion and pressure
    • temporarily restores freer breathing through the nose

Warnings

     

Do Not Use


  • if you have ever had an allergic reaction to this product or any of its ingredients

  • if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.

  • if you have difficulty swallowing

Ask A Doctor Before Use If You Have

  • heart disease
  • thyroid disease
  • glaucoma
  • high blood pressure
  • diabetes
  • trouble urinating due to an enlarged prostate gland
  • 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 Doctor If


  • an allergic reaction to this product occurs. Seek medical help right away.

  • symptoms do not improve within 7 days or are accompanied by a fever

  • you get nervous, dizzy, or sleepless

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


  • do not divide, crush, chew or dissolve the tablet; swallow tablet whole

    • adults and children 12 years of age and over
    		take 1 tablet with a glass of water every 12 hours on an empty stomach; 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

Other Information

  • safety sealed; do not use if inner safety seal is open or torn
  • store between 20° to 25°C (68° to 77°F)
  • USP dissolution test is pending.

Inactive Ingredients


colloidal silicon dioxide, croscarmellose sodium, dibasic calcium phosphate dihydrate, ethyl cellulose, ferric oxide yellow, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, stearic acid.

Questions?


Call toll free 1-800-818-4555 weekdays

Other

Distributed By AmerisourceBergen
1300 Morris Drive, Chesterbrook, PA 19087

Principal Display Panel - 60 Mg/120 Mg Tablet Blister Pack Carton

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Compare to Allegra-D® active ingredients**

NDC 46122-452-60

Original Prescription Strength

NON-DROWSY

12 HOUR

fexofenadine HCl 60 mg/antihistamine
pseudoephedrine HCl 120 mg/nasal decongestant
Extended-Release Tablets, USP

Indoor & Outdoor Allergies

Allergy & Congestion

Relief of:

  • Nasal and Sinus Congestion Due to Colds or Allergies
  • Sneezing; Runny Nose; Itchy, Watery Eyes and Itchy Nose or
    Throat Due to Allergies

    • 20 Extended-Release Tablets

    Principal Display Panel (60 mg/120 mg Tablet Blister Pack Carton)

    Principal Display Panel (60 mg/120 mg Tablet Blister Pack Carton)

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