Source label information, not individualized medical advice. This record applies to the product and labeler shown below. Compare the exact formulation, strength and country with your package and the current source label.
Generic nameFEXOFENADINE HYDROCHLORIDE ORAL
Labeler / manufacturerAurohealth LLC
RouteORAL
Drug classDrug class not supplied in source label
Product NDC58602-427
Label effective date2026-09-01
Official product label reference
Fexofenadine Hydrochloride — Aurohealth LLC
This page contains 12 source sections for FEXOFENADINE HYDROCHLORIDE ORAL, oral route. Label set fe864426-c0d6-492a-96be-cd44fd9ca054, version 1.
Label records can cover multiple strengths or package sizes. A label listing does not by itself establish FDA approval or current market availability. Check the source and application history for this specific product.
Uses described in the label
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
Purpose
Purpose Antihistamine
Dosage and administration — label text
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
Table text from source:
| 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
Warnings
Warnings Do not use if you have ever had an allergic reaction to this product or any of its ingredients.
Active ingredient
Drug Facts Active ingredient (in each 5 mL) Fexofenadine Hydrochloride USP 30 mg
Ask a doctor before use
Ask a doctor before use if you have kidney disease. Your doctor should determine if you need a different dose.
While using this medicine
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)
When to stop use and seek help
Stop use and ask a doctor if an allergic reaction to this product occurs. Seek medical help right away.
Pregnancy or breast feeding
If pregnant or breast-feeding, ask a health professional before use.
Child safety
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.
Storage and handling
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 ingredient
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
The text is extracted from a US structured product label. Tables are represented as text where supplied; formatting and illustrations may be lost. A missing section does not mean a risk is absent. This reference has not been independently reviewed by a clinician and is not a live safety-alert service.