Fexofenadine Hydrochloride Oral Suspension 30 Mg/5 Ml

Drug Facts

Composition & Product

Active Ingredients

Fexofenadine (30 mg)

Inactive Ingredients

Strawberry Sodium Phosphate, Dibasic, Anhydrous Edetate Disodium Ethylparaben Methylparaben Modified Corn Starch (1-octenyl Succinic Anhydride) Sodium Phosphate, Monobasic, Monohydrate Poloxamer 407 Propylene Glycol Water Sucrose Titanium Dioxide Triacetin Xanthan Gum Xylitol

Identifiers & Packaging

Pill Appearance

Color: white

Marketing Status

ANDA Active Since 2023-05-23

Medication Information

Purpose

Antihistamine

Description

Active ingredient (in each 5 mL) Fexofenadine Hydrochloride USP 30 mg

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 53414-9

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

Warnings

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

Directions

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

Drug Facts

Active ingredient (in each 5 mL)

Fexofenadine Hydrochloride USP 30 mg

Other Information

each 5 mL contains: phosphorus 15 mg and sodium18 mg
safety sealed: do not use if carton is opened or seal under cap opening is broken or missing
store between 20° to 25°C (68° to 77°F)

Inactive Ingredients

art strawberry flavor, dibasic sodium phosphate anhydrous, edetate disodium, ethylparaben, methylparaben, modified food starch (corn), monobasic sodium phosphate, poloxamer 407, propylene glycol, purified water, sucrose, titanium dioxide, triacetin, xanthan gum, xylitol.

Questions Or Comments?

call 1-855-274-4122 (Monday - Friday 8:30 AM to 5:00 PM EST)

Distributed by:

AUROHEALTH LLC

279 Princeton-Hightstown Road

East Windsor, NJ 08520

Made in India

Code: AP/DRUGS/04/2016

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.

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.

Ask A Doctor Before Use If You Have

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

Package Label Principal Display Panel 8 fl. oz.(240 Ml Bottle) container Label

AUROHEALTH

NDC 58602-426-20

Ages 2 Years & Older

NON-DROWSY

Children’s

Fexofenadine Hydrochloride

Oral Suspension

30 mg/5 mL

antihistamine

INDOOR / OUTDOOR ALLERGY RELIEF

Dosing Cup Included

Wash and let air dry

after each use

12 HR

Berry

FLAVOR

Alcohol & Dye FREE

8 fl. oz. (240 mL)

Package Label Principal Display Panel 8 fl. oz. (240 Ml Bottle) Carton Container Label

AUROHEALTH

NDC 58602-426-20

^#Compare to the active Ingredient

in Children’s Allegra^®Allergy

Ages 2 Years & Older

Children’s

Fexofenadine Hydrochloride

Oral Suspension

30 mg/5 mL

antihistamine 12 HR

NON-DROWSY

Liquid

INDOOR / OUTDOOR ALLERGY RELIEF

√ Sneezing

√ Runny Nose

√ Itchy, Watery Eyes

√ Itchy Nose or Throat

Use Only With

Enclosed Dosing Cup

Wash and let air dry after each use

Berry

FLAVOR

Alcohol & Dye FREE

8 fl. oz. (240 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 53414-9 (53414-9)

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

Purpose

Antihistamine

Warnings

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

Directions

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

Drug Facts

Active ingredient (in each 5 mL)

Fexofenadine Hydrochloride USP 30 mg

Other Information (Other information)

each 5 mL contains: phosphorus 15 mg and sodium18 mg
safety sealed: do not use if carton is opened or seal under cap opening is broken or missing
store between 20° to 25°C (68° to 77°F)

Inactive Ingredients (Inactive ingredients)

art strawberry flavor, dibasic sodium phosphate anhydrous, edetate disodium, ethylparaben, methylparaben, modified food starch (corn), monobasic sodium phosphate, poloxamer 407, propylene glycol, purified water, sucrose, titanium dioxide, triacetin, xanthan gum, xylitol.

Questions Or Comments? (Questions or comments?)

call 1-855-274-4122 (Monday - Friday 8:30 AM to 5:00 PM EST)

Distributed by:

AUROHEALTH LLC

279 Princeton-Hightstown Road

East Windsor, NJ 08520

Made in India

Code: AP/DRUGS/04/2016

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.

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.

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.

Package Label Principal Display Panel 8 fl. oz.(240 Ml Bottle) container Label (PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 8 fl. oz.(240 mL Bottle) Container Label)

AUROHEALTH

NDC 58602-426-20

Ages 2 Years & Older

NON-DROWSY

Children’s

Fexofenadine Hydrochloride

Oral Suspension

30 mg/5 mL

antihistamine

INDOOR / OUTDOOR ALLERGY RELIEF

Dosing Cup Included

Wash and let air dry

after each use

12 HR

Berry

FLAVOR

Alcohol & Dye FREE

8 fl. oz. (240 mL)

Package Label Principal Display Panel 8 fl. oz. (240 Ml Bottle) Carton Container Label (PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 8 fl. oz. (240 mL Bottle) Carton Container Label)

AUROHEALTH

NDC 58602-426-20

^#Compare to the active Ingredient

in Children’s Allegra^®Allergy

Ages 2 Years & Older

Children’s

Fexofenadine Hydrochloride

Oral Suspension

30 mg/5 mL

antihistamine 12 HR

NON-DROWSY

Liquid

INDOOR / OUTDOOR ALLERGY RELIEF

√ Sneezing

√ Runny Nose

√ Itchy, Watery Eyes

√ Itchy Nose or Throat

Use Only With

Enclosed Dosing Cup

Wash and let air dry after each use

Berry

FLAVOR

Alcohol & Dye FREE

8 fl. oz. (240 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", "53414-9": "If pregnant or breast-feeding, ask a health professional before use.", "Purpose": "Antihistamine", "Warnings": "Do not use if you have ever had an allergic reaction to this product or any of its ingredients.", "Directions": "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", "Drug Facts": "Active ingredient (in each 5 mL) Fexofenadine Hydrochloride USP 30 mg", "Other information": "each 5 mL contains: phosphorus 15 mg and sodium18 mg safety sealed: do not use if carton is opened or seal under cap opening is broken or missing store between 20° to 25°C (68° to 77°F)", "Inactive ingredients": "art strawberry flavor, dibasic sodium phosphate anhydrous, edetate disodium, ethylparaben, methylparaben, modified food starch (corn), monobasic sodium phosphate, poloxamer 407, propylene glycol, purified water, sucrose, titanium dioxide, triacetin, xanthan gum, xylitol.", "Questions or comments?": "call 1-855-274-4122 (Monday - Friday 8:30 AM to 5:00 PM EST) Distributed by: AUROHEALTH LLC 279 Princeton-Hightstown Road East Windsor, NJ 08520 Made in India Code: AP/DRUGS/04/2016", "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.", "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.", "Ask a doctor before use if you have": "kidney disease. Your doctor should determine if you need a different dose.", "PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 8 fl. oz.(240 mL Bottle) Container Label": "AUROHEALTH NDC 58602-426-20 Ages 2 Years & Older NON-DROWSY Children’s Fexofenadine Hydrochloride Oral Suspension 30 mg/5 mL antihistamine INDOOR / OUTDOOR ALLERGY RELIEF Dosing Cup Included Wash and let air dry after each use 12 HR Berry FLAVOR Alcohol & Dye FREE 8 fl. oz. (240 mL)", "PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 8 fl. oz. (240 mL Bottle) Carton Container Label": "AUROHEALTH NDC 58602-426-20 # Compare to the active Ingredient in Children’s Allegra ® Allergy Ages 2 Years & Older Children’s Fexofenadine Hydrochloride Oral Suspension 30 mg/5 mL antihistamine 12 HR NON-DROWSY Liquid INDOOR / OUTDOOR ALLERGY RELIEF √ Sneezing √ Runny Nose √ Itchy, Watery Eyes √ Itchy Nose or Throat Use Only With Enclosed Dosing Cup Wash and let air dry after each use Berry FLAVOR Alcohol & Dye FREE 8 fl. oz. (240 mL)"}

Fexofenadine Hydrochloride Oral Suspension 30 Mg/5 Ml

Drug Facts

Composition & Product

Identifiers & Packaging

Medication Information

Structured Label Content

Advanced Ingredient Data

Raw Label Data

Additional Information