Allegra D 12 Hour Allergy And Congestion
FDA Label NDC 21695-931

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Rebel Distributors Corp for the product Allegra D 12 Hour Allergy And Congestion (NDC 21695-931). 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 other, active ingredients, purpose, uses, do not use, ask a doctor before use if you have, when using this product, stop use and ask a doctor if, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Other

Drug Facts

Active Ingredients

(in each tablet)

Fexofenadine HCI 60 mg

(in each tablet)

Pseudoephedrine HCI 120 mg

Purpose

Antihistamine

Nasal decongestant

Uses

  • temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:
    ▪    runny nose
    ▪    sneezing
    ▪    nasal congestion
    ▪    itchy, watery eyes
    ▪    itching of the nose or throat
  • reduces swelling of nasal passages
  • temporarily relieves sinus congestion and pressure
  • temporarily restores freer breathing through the nose

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)
  • the tablet coating may be seen in the stool (this is normal). Continue to take as directed (see Directions).

Stop Use And Ask A 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 overtake 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 agedo not use
    adults 65 years of age and olderask a doctor
    consumers with kidney diseaseask a doctor

Other Information

  • safety sealed: 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)

Inactive Ingredients

carnauba wax, colloidal silicon dioxide, croscarmellose sodium, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, pregelatinized starch, stearic acid

Questions Or Comments?

call toll-free 1-800-633-1610 or www.allegra.com

The makers of Allegra® do not make store brand products.

The trade dress of this Allegra® package is subject to trademark protection.

Dist. By: Chattem, Inc. (part of the sanofi-aventis Group),

Chattanooga, TN 37409-0219 ©2010       50094535

* Please review the disclaimer below.