Children's Allergy

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 2022-07-18 Until 2025-06-30

Medication Information

Purpose

Antihistamine

Description

Drug Facts

Uses

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

runny nose
itchy, watery eyes
sneezing
itching of the nose or throat

Section 42229-5

Drug Facts

Section 50565-1

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.

Section 50566-9

Stop use and ask a doctor if an allergic reaction to this product occurs. Seek medical help right away.

Section 50569-3

Ask a doctor before use if you have kidney disease. Your doctor should determine if you need a different dose.

Section 50570-1

Do not use if you have ever had an allergic reaction to this product or any of its ingredients.

Section 53414-9

If pregnant or breast-feeding, ask a health professional before use.

Directions

shake well before using
use only with enclosed dosing cup

Note: mL = milliliters
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

Other Information

each 5 mL contains: sodium 18 mg
store between 20° to 25°C (68° to 77°F)
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

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)

Active Ingredient (in Each 5 Ml)

Fexofenadine HCl, USP 30 mg

Principal Display Panel 237 Ml Bottle Carton

NDC 61269-527-98

*Compare to the active ingredient

in Children's Allegra® Allergy

Children's

Allergy

Fexofenadine HCl

Oral Suspension 30 mg/5 mL

Antihistamine

Indoor/Outdoor allergy relief

Sneezing

Runny nose

Itchy, watery eyes

Itchy nose or throat

12 Hour Relief

Ages 2 years and older

Non-drowsy

Dye-free

Alcohol-free

Use only with

enclosed dosing cup.

Wash and let air dry

after each use.

BERRY FLAVOR

8 fl oz (237 mL)

H² pharma

Structured Label Content

Uses

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

runny nose
itchy, watery eyes
sneezing
itching of the nose or throat

Section 42229-5 (42229-5)

Drug Facts

Section 50565-1 (50565-1)

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.

Section 50566-9 (50566-9)

Stop use and ask a doctor if an allergic reaction to this product occurs. Seek medical help right away.

Section 50569-3 (50569-3)

Ask a doctor before use if you have kidney disease. Your doctor should determine if you need a different dose.

Section 50570-1 (50570-1)

Do not use if you have ever had an allergic reaction to this product or any of its ingredients.

Section 53414-9 (53414-9)

If pregnant or breast-feeding, ask a health professional before use.

Purpose

Antihistamine

Directions

shake well before using
use only with enclosed dosing cup

Note: mL = milliliters
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

Other Information (Other information)

each 5 mL contains: sodium 18 mg
store between 20° to 25°C (68° to 77°F)
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

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)

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

Fexofenadine HCl, USP 30 mg

Principal Display Panel 237 Ml Bottle Carton (PRINCIPAL DISPLAY PANEL - 237 mL Bottle Carton)

NDC 61269-527-98

*Compare to the active ingredient

in Children's Allegra® Allergy

Children's

Allergy

Fexofenadine HCl

Oral Suspension 30 mg/5 mL

Antihistamine

Indoor/Outdoor allergy relief

Sneezing

Runny nose

Itchy, watery eyes

Itchy nose or throat

12 Hour Relief

Ages 2 years and older

Non-drowsy

Dye-free

Alcohol-free

Use only with

enclosed dosing cup.

Wash and let air dry

after each use.

BERRY FLAVOR

8 fl oz (237 mL)

H² pharma

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 itchy, watery eyes sneezing itching of the nose or throat", "42229-5": "Drug Facts", "50565-1": "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.", "50566-9": "Stop use and ask a doctor if an allergic reaction to this product occurs. Seek medical help right away.", "50569-3": "Ask a doctor before use if you have kidney disease. Your doctor should determine if you need a different dose.", "50570-1": "Do not use if you have ever had an allergic reaction to this product or any of its ingredients.", "53414-9": "If pregnant or breast-feeding, ask a health professional before use.", "Purpose": "Antihistamine", "Directions": "shake well before using use only with enclosed dosing cup Note: mL = milliliters 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", "Other information": "each 5 mL contains: sodium 18 mg store between 20° to 25°C (68° to 77°F) 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", "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 )", "Active ingredient (in each 5 mL)": "Fexofenadine HCl, USP 30 mg", "PRINCIPAL DISPLAY PANEL - 237 mL Bottle Carton": "NDC 61269-527-98 *Compare to the active ingredient in Children's Allegra® Allergy Children's Allergy Fexofenadine HCl Oral Suspension 30 mg/5 mL Antihistamine Indoor/Outdoor allergy relief Sneezing Runny nose Itchy, watery eyes Itchy nose or throat 12 Hour Relief Ages 2 years and older Non-drowsy Dye-free Alcohol-free Use only with enclosed dosing cup. Wash and let air dry after each use. BERRY FLAVOR 8 fl oz (237 mL) H 2 pharma"}

Drug Facts

Composition & Product

Identifiers & Packaging

Medication Information

Structured Label Content

Advanced Ingredient Data

Raw Label Data

Additional Information