Children's Fexofenadine Hcl

Drug Facts

Composition & Product

Active Ingredients

Fexofenadine (30 mg)

Inactive Ingredients

Edetate Disodium Maltitol Poloxamer 407 Propylene Glycol Water Sodium Phosphate, Dibasic, Heptahydrate Sodium Phosphate, Monobasic, Monohydrate Sucralose Potassium Sorbate Titanium Dioxide Xanthan Gum Sodium Benzoate

Identifiers & Packaging

Pill Appearance

Color: white

Marketing Status

ANDA Active Since 2024-12-06

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 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

Questions?

Call 1-888-287-1915

Other Information

each 5 mL contains: sodium 14 mg
safety sealed: do not use if carton is opened, or if foil inner seal on bottle is torn or missing
store between 20º and 25ºC (68º and 77ºF)

Inactive Ingredients

artificial raspberry flavor, edetate disodium, maltitol solution, poloxamer 407, potassium sorbate, propylene glycol, purified water, sodium benzoate, sodium phosphate dibasic heptahydrate, sodium phosphate monobasic monohydrate, sucralose powder, titanium dioxide and xanthan gum

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 30 mg

Principal Display Panel 120 Ml Bottle Carton

NDC 79903-306-04

Compare to the active

ingredient in Children's

Allegra ^®Allergy*

Children's

Allergy Relief

Fexofenadine HCl

Oral Suspension,

30 mg/ 5 mL

Antihistamine

NON-DROWSY

12

Hour

Berry Flavor

AGES 2

YEARS

AND OLDER

Indoor/Outdoor

Allergy Relief

4 FL OZ

(120 mL)

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 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

Questions?

Call 1-888-287-1915

Other Information (Other information)

each 5 mL contains: sodium 14 mg
safety sealed: do not use if carton is opened, or if foil inner seal on bottle is torn or missing
store between 20º and 25ºC (68º and 77ºF)

Inactive Ingredients (Inactive ingredients)

artificial raspberry flavor, edetate disodium, maltitol solution, poloxamer 407, potassium sorbate, propylene glycol, purified water, sodium benzoate, sodium phosphate dibasic heptahydrate, sodium phosphate monobasic monohydrate, sucralose powder, titanium dioxide and xanthan gum

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 30 mg

Principal Display Panel 120 Ml Bottle Carton (PRINCIPAL DISPLAY PANEL - 120 mL Bottle Carton)

NDC 79903-306-04

Compare to the active

ingredient in Children's

Allegra ^®Allergy*

Children's

Allergy Relief

Fexofenadine HCl

Oral Suspension,

30 mg/ 5 mL

Antihistamine

NON-DROWSY

12

Hour

Berry Flavor

AGES 2

YEARS

AND OLDER

Indoor/Outdoor

Allergy Relief

4 FL OZ

(120 mL)

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 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", "Questions?": "Call 1-888-287-1915", "Other information": "each 5 mL contains: sodium 14 mg safety sealed: do not use if carton is opened, or if foil inner seal on bottle is torn or missing store between 20º and 25ºC (68º and 77ºF)", "Inactive ingredients": "artificial raspberry flavor, edetate disodium, maltitol solution, poloxamer 407, potassium sorbate, propylene glycol, purified water, sodium benzoate, sodium phosphate dibasic heptahydrate, sodium phosphate monobasic monohydrate, sucralose powder, titanium dioxide and xanthan gum", "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 30 mg", "PRINCIPAL DISPLAY PANEL - 120 mL Bottle Carton": "NDC 79903-306-04 Compare to the active ingredient in Children's Allegra ® Allergy* Children's Allergy Relief Fexofenadine HCl Oral Suspension, 30 mg/ 5 mL Antihistamine NON-DROWSY 12 Hour Berry Flavor AGES 2 YEARS AND OLDER Indoor/Outdoor Allergy Relief 4 FL OZ (120 mL)"}

Drug Facts

Composition & Product

Identifiers & Packaging

Medication Information

Structured Label Content

Advanced Ingredient Data

Raw Label Data

Additional Information