Drug Facts

Composition & Product

Active Ingredients

Fexofenadine (30 mg)

Inactive Ingredients

Butylparaben Edetate Disodium Poloxamer 407 Propylene Glycol Propylparaben Water Sodium Phosphate, Dibasic, Anhydrous Sodium Phosphate, Monobasic, Anhydrous Sucrose Titanium Dioxide Xanthan Gum Xylitol

Identifiers & Packaging

Marketing Status

ANDA Active Since 2023-07-01

Medication Information

Purpose

Antihistamine

Description

Fexofenadine HCl, USP 30 mg

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

Direction

shake well before using
use only with enclosed dosing cup

adults and children 12 years of age and over	take 10 mL every 12 hours; do not take more than 20 mL in 24 hours
children 2 to under 12 years of age	take 5 mL every 12 hours; do not take more than 10 mL in 24 hours
children under 2 years of age	ask a doctor
adults 65 years of age and older	ask a doctor
consumers with kidney disease	ask a doctor

Note: mL = milliliters

Do Not Use

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

Product Label

FAMILY WELLNESS Children's Allergy Berry Flavor

Other Information

each 5 mL contains: sodium 18 mg
store between 20º to 25ºC (68º and 77ºF)
before using any medication, read all label directions. Keep carton, it contains important information.

Inactive Ingredients

artificial raspberry flavor, butylparaben, edetate disodium, poloxamer 407, propylene glycol, propylparaben, purified water, sodium phosphate dibasic, sodium phosphate monobasic, sucrose, titanium dioxide, xanthan gum, xylitol

Questions Or Comments?

Call 1-877-753-3935 Monday-Friday 9AM-5PM EST

Principal Display Panel

COMPARE TO THE ACTIVE INGREDIENT IN CHILDREN'S ALLEGRA® ALLERGY*

Children's

ALLERGY

AGES 2 YEARS & UP

FEXOFENADINE HCl

ORAL SUSPENSION 30 mg/5mL

Antihistamine

Indoor/Outdoor allergy relief

Sneezing
Runny nose
Itchy, watery eyes
Itchy nose or throat

12 HOUR

Non-drowsy

Alcohol-free

DYE-FREE

BERRY FLAVOR

FL OZ (mL)

Use only with enclosed dosing cup. Wash and let air dry after each use

*This product is not manufactured or distributed by Chattem Inc., distributor of Children's Allegra® Allergy.

KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION

TAMPER EVIDENT: DO NOT USE IF CARTON, UNPRINTED FOIL INNER SEAL OR NECKBAND PRINTED WITH "SEAL FOR YOUR PROTECTION" IS OPENED, TORN OR MISSING

KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION

DISTRIBUTED BY

MIDWOOD BRANDS, LLC

500 VOLVO PARKWAY,

CHESAPEAKE, VA 23320

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 (1-800-222-1222) right away.

Active Ingredient (in Each 5 Ml)

Fexofenadine HCl, USP 30 mg

Ask A Doctor Before Use If You Have

kidney disease. Your doctor should determine if you need a different dose.

Structured Label Content

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

Purpose

Antihistamine

Direction

shake well before using
use only with enclosed dosing cup

adults and children 12 years of age and over	take 10 mL every 12 hours; do not take more than 20 mL in 24 hours
children 2 to under 12 years of age	take 5 mL every 12 hours; do not take more than 10 mL in 24 hours
children under 2 years of age	ask a doctor
adults 65 years of age and older	ask a doctor
consumers with kidney disease	ask a doctor

Note: mL = milliliters

Do Not Use (Do not use)

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

Product Label

FAMILY WELLNESS Children's Allergy Berry Flavor

Other Information (Other information)

each 5 mL contains: sodium 18 mg
store between 20º to 25ºC (68º and 77ºF)
before using any medication, read all label directions. Keep carton, it contains important information.

Inactive Ingredients (Inactive ingredients)

artificial raspberry flavor, butylparaben, edetate disodium, poloxamer 407, propylene glycol, propylparaben, purified water, sodium phosphate dibasic, sodium phosphate monobasic, sucrose, titanium dioxide, xanthan gum, xylitol

Questions Or Comments? (Questions or comments?)

Call 1-877-753-3935 Monday-Friday 9AM-5PM EST

Principal Display Panel

COMPARE TO THE ACTIVE INGREDIENT IN CHILDREN'S ALLEGRA® ALLERGY*

Children's

ALLERGY

AGES 2 YEARS & UP

FEXOFENADINE HCl

ORAL SUSPENSION 30 mg/5mL

Antihistamine

Indoor/Outdoor allergy relief

Sneezing
Runny nose
Itchy, watery eyes
Itchy nose or throat

12 HOUR

Non-drowsy

Alcohol-free

DYE-FREE

BERRY FLAVOR

FL OZ (mL)

Use only with enclosed dosing cup. Wash and let air dry after each use

*This product is not manufactured or distributed by Chattem Inc., distributor of Children's Allegra® Allergy.

KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION

TAMPER EVIDENT: DO NOT USE IF CARTON, UNPRINTED FOIL INNER SEAL OR NECKBAND PRINTED WITH "SEAL FOR YOUR PROTECTION" IS OPENED, TORN OR MISSING

KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION

DISTRIBUTED BY

MIDWOOD BRANDS, LLC

500 VOLVO PARKWAY,

CHESAPEAKE, VA 23320

When Using This Product (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 (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 (1-800-222-1222) right away.

Active Ingredient (in Each 5 Ml) (Active ingredient (in each 5 mL))

Fexofenadine HCl, USP 30 mg

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.

Advanced Ingredient Data

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Raw Label Data

All Sections (JSON)

{"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", "Purpose": "Antihistamine", "Direction": "shake well before using use only with enclosed dosing cup adults and children 12 years of age and over take 10 mL every 12 hours; do not take more than 20 mL in 24 hours children 2 to under 12 years of age take 5 mL every 12 hours; do not take more than 10 mL in 24 hours children under 2 years of age ask a doctor adults 65 years of age and older ask a doctor consumers with kidney disease ask a doctor Note: mL = milliliters", "Do not use": "if you have ever had an allergic reaction to this product or any of its ingredients.", "Product Label": "FAMILY WELLNESS Children's Allergy Berry Flavor", "Other information": "each 5 mL contains: sodium 18 mg store between 20º to 25ºC (68º and 77ºF) before using any medication, read all label directions. Keep carton, it contains important information.", "Inactive ingredients": "artificial raspberry flavor, butylparaben, edetate disodium, poloxamer 407, propylene glycol, propylparaben, purified water, sodium phosphate dibasic, sodium phosphate monobasic, sucrose, titanium dioxide, xanthan gum, xylitol", "Questions or comments?": "Call 1-877-753-3935 Monday-Friday 9AM-5PM EST", "Principal Display Panel": "COMPARE TO THE ACTIVE INGREDIENT IN CHILDREN'S ALLEGRA® ALLERGY* Children's ALLERGY AGES 2 YEARS & UP FEXOFENADINE HCl ORAL SUSPENSION 30 mg/5mL Antihistamine Indoor/Outdoor allergy relief Sneezing Runny nose Itchy, watery eyes Itchy nose or throat 12 HOUR Non-drowsy Alcohol-free DYE-FREE BERRY FLAVOR FL OZ (mL) Use only with enclosed dosing cup. Wash and let air dry after each use *This product is not manufactured or distributed by Chattem Inc., distributor of Children's Allegra® Allergy. KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION TAMPER EVIDENT: DO NOT USE IF CARTON, UNPRINTED FOIL INNER SEAL OR NECKBAND PRINTED WITH "SEAL FOR YOUR PROTECTION" IS OPENED, TORN OR MISSING KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION DISTRIBUTED BY MIDWOOD BRANDS, LLC 500 VOLVO PARKWAY, CHESAPEAKE, VA 23320", "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 (1-800-222-1222) right away.", "Active ingredient (in each 5 mL)": "Fexofenadine HCl, USP 30 mg", "Ask a doctor before use if you have": "kidney disease. Your doctor should determine if you need a different dose."}

Drug Facts

Drug Facts

Composition & Product

Identifiers & Packaging

Medication Information

Structured Label Content

Advanced Ingredient Data

Raw Label Data

Additional Information