Childrens Allegra Allergy Tablet, Orally Disintegrating
FDA Label NDC 41167-4232

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Chattem, Inc. for the product Childrens Allegra Allergy (NDC 41167-4232). 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, purpose, uses, do not use, ask a doctor before use if you have, stop use and ask a doctor if, if pregnant or breast-feeding,, keep out of reach of children., 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 HCI 30 mg

Purpose

Antihistamine

Uses

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

  • runny nose
  • sneezing
  • itchy, water eyes
  • itching of the nose or throat

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

  • place 1 tablet on tongue; tablet disintegrates, with or without water
    • adults and children 12 years of age and overtake 2 tablets every 12 hours on an empty stomach; do not take more than 4 tablets in 24 hours
    children 6 to under 12 years of agetake 1 tablet every 12 hours on an empty stomach; do not take more than 2 tablets in 24 hours
    children under 6 years of agedo not use
    adults 65 years of age and olderask a doctor
    consumers with kidney diseaseask a doctor

Other Information

  • each tablet contains: sodium 5 mg
  • phenylketonurics: contains phenylalanine 5.3 mg per tablet
  • 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)
  • use tablet immediately after opening individual blister

Inactive Ingredients

aspartame, citric acid anhydrous, crospovidone, flavors, magnesium stearate, mannitol, methacrylic acid copolymer, microcrystalline cellulose, povidone, sodium bicarbonate, sodium starch glycolate

Questions Or Comments?

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

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

Chattanooga, TN 37409-0219 ©2010             50094020

Principal Display Panel

NDC 41167-4232-1
NON-DROWSY
Children’s
Allegra® 
Allergy
fexofenadine HCl orally disintegrating
tablet 30 mg/antihistamine
Indoor and Outdoor Allergies
Orange Cream flavored
12 Orally Disintegrating Tablets

Principal Display Panelndc 41167-4232-1non-drowsychildren’sallegra® Allergyfexofenadine HCl Orally Disintegratingtablet 30 mg/antihistamineindoor And Outdoor Allergiesorange Cream Flavored12 Orally Disintegrating Tablets (Childrens Allegra Allergy 01)

Principal Display Panelndc 41167-4232-1non-drowsychildren’sallegra® Allergyfexofenadine HCl Orally Disintegratingtablet 30 mg/antihistamineindoor And Outdoor Allergiesorange Cream Flavored12 Orally Disintegrating Tablets (Childrens Allegra Allergy 01)

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