Fexofenadine Hydrochloride Suspension
FDA Label NDC 58602-427

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Aurohealth Llc for the product Fexofenadine Hydrochloride (NDC 58602-427). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding drug facts, purpose, uses, warnings, ask a doctor before use if you have, when using this product, stop use and ask a doctor if, otc - pregnancy or breast feeding, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Drug Facts

Active ingredient (in each 5 mL)  

Fexofenadine Hydrochloride USP 30 mg

Purpose

Antihistamine

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

Warnings

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

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)

Stop Use And Ask A Doctor If

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


Otc - Pregnancy Or Breast Feeding

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.

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

Other Information

  • each 5 mL contains: phosphorus 15 mg and sodium 18 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

dibasic sodium phosphate anhydrous, edetate disodium, ethylparaben, methylparaben, monobasic sodium phosphate, poloxamer 407, propylene glycol, purified water, raspberry flavor (contains propylene glycol and triacetin), raspberry sweet flavor (contains propylene glycol), sucrose, titanium dioxide, 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

Package Label-Principal Display Panel - 8 Fl. Oz.(240 Ml Bottle) Container Label

AUROHEALTH

NDC 58602-427-20

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

Raspberry
FLAVOR


Alcohol & Dye FREE

 8 fl. oz. (240 mL)


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)

Package Label-Principal Display Panel - 8 Fl. Oz. (240 Ml Bottle) Carton Container Label

AUROHEALTH

NDC 58602-427-20
#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 

Raspberry
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)

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