Childrens Allegra Allergy

Childrens Allegra Allergy
SPL v16
SPL
SPL Set ID 06115cea-5a44-409d-85ed-bb71743491c1
Route
ORAL
Published
Effective Date 2025-02-18
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Fexofenadine (30 mg)
Inactive Ingredients
Aspartame Crospovidone Lactose Monohydrate Magnesium Stearate Methacrylic Acid And Ethyl Acrylate Copolymer Cellulose, Microcrystalline Povidone Silicon Dioxide

Identifiers & Packaging

Pill Appearance
Imprint: e;311;AV Shape: round Color: white Size: 11 mm Score: 1
Marketing Status
NDA Completed Since 2014-01-02 Until 2024-12-01

Description

Drug Facts

Purpose

Antihistamine


Medication Information

Purpose

Antihistamine

Description

Drug Facts

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
Section 42229-5

Drug Facts

Directions
  • place 1 tablet on tongue; tablet disintegrates, with or without water
adults and children 12 years of age and over take 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 age take 1 tablet every 12 hours on an empty stomach; do not take more than 2 tablets in 24 hours
children under 6 years of age do not use
adults 65 years of age and older ask a doctor
consumers with kidney disease ask a doctor
Do Not Use

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

Active Ingredient

(in each tablet)

Fexofenadine HCI 30 mg

Other Information
  • phenylketonurics: contains phenylalanine 3.8 mg per tablet

  • safety sealed: do not use if carton is opened or if individual blister units are torn or opened

  • store between 20º and 25ºC (68º and 77ºF)

  • use tablet immediately after opening individual blister

  • contains lactose
Inactive Ingredients

aspartame, crospovidone, flavors, lactose monohydrate, magnesium stearate, methacrylic acid copolymer, microcrystalline cellulose, povidone, silicon dioxide

Questions Or Comments?

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

Dist. By: Chattem, Inc, a Sanofi Company,

Chattanooga, TN 37409-0219 ©2015

Principal Display Panel

NDC 41167-4232-1

NON-DROWSY


Children’s


Allegra
®  

Allergy


fexofenadine HC
l orally disintegrating

tablet 30
mg/antihista mine

Indoor and Outdoor Aller
gies

Orange Cream flavor


12 Orally Disintegrating Tablets

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.

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)

Structured Label Content

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
Section 42229-5 (42229-5)

Drug Facts

Purpose

Antihistamine

Directions
  • place 1 tablet on tongue; tablet disintegrates, with or without water
adults and children 12 years of age and over take 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 age take 1 tablet every 12 hours on an empty stomach; do not take more than 2 tablets in 24 hours
children under 6 years of age do not use
adults 65 years of age and older ask a doctor
consumers with kidney disease ask a doctor
Do Not Use (Do not use)

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

Active Ingredient (Active ingredient)

(in each tablet)

Fexofenadine HCI 30 mg

Other Information (Other information)
  • phenylketonurics: contains phenylalanine 3.8 mg per tablet

  • safety sealed: do not use if carton is opened or if individual blister units are torn or opened

  • store between 20º and 25ºC (68º and 77ºF)

  • use tablet immediately after opening individual blister

  • contains lactose
Inactive Ingredients (Inactive ingredients)

aspartame, crospovidone, flavors, lactose monohydrate, magnesium stearate, methacrylic acid copolymer, microcrystalline cellulose, povidone, silicon dioxide

Questions Or Comments? (Questions or comments?)

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

Dist. By: Chattem, Inc, a Sanofi Company,

Chattanooga, TN 37409-0219 ©2015

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

NDC 41167-4232-1

NON-DROWSY


Children’s


Allegra
®  

Allergy


fexofenadine HC
l orally disintegrating

tablet 30
mg/antihista mine

Indoor and Outdoor Aller
gies

Orange Cream flavor


12 Orally Disintegrating Tablets

Stop Use and Ask A Doctor If (Stop use and ask a doctor if)

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

If Pregnant Or Breast Feeding, (If pregnant or breast-feeding,)

ask a health professional before use.

Keep Out of Reach of Children. (Keep out of reach of children.)

In case of overdose, get medical help or contact a Poison Control Center right away.

Ask A Doctor Before Use If You Have (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)

Advanced Ingredient Data


Raw Label Data

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