Fexofenadine Hydrochloride Oral Suspension 30 mg/5 mL

Manufacturer
Aurohealth LLC | APL HEALTHCARE LIMITED
Effective date
2026-09-01
Label type
Human OTC Drug Label
Version
1
Source
daily-update
Hydrated at
2026-09-05 01:00:59

Label at a glance#

ProductFEXOFENADINE HYDROCHLORIDE
Active ingredientFexofenadine Hydrochloride
Label structure14 sections

Indications and 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

Dosage and administration

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 = mi...

Storage and handling

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)

Label contents#

Full prescribing information#

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

Active ingredient (in each 5 mL)  

Fexofenadine Hydrochloride USP 30 mg

Purpose

OTC - PURPOSE SECTION

Antihistamine

Uses

INDICATIONS & USAGE SECTION

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

WARNINGS SECTION

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

OTC - ASK DOCTOR SECTION

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

When using this product

OTC - WHEN USING SECTION

  • 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

OTC - STOP USE SECTION

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


OTC - PREGNANCY OR BREAST FEEDING SECTION

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

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Directions

DOSAGE & ADMINISTRATION SECTION

  • 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

STORAGE AND HANDLING SECTION

  • 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

INACTIVE INGREDIENT SECTION

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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 LabelPACKAGE 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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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 LabelPACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 8 fl. oz. (240 mL Bottle) Carton Container Label

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 16 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
58602-42758602-427-24, 58602-427-20

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 14 matching rows.

Source Document#

Source XML

Orange Book application contexts#

All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.

Orange Book application contexts page 1 of 1 · 1 matching rows.

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A213466-001FEXOFENADINE HYDROCHLORIDEFEXOFENADINE HYDROCHLORIDE30MG/5MLSUSPENSION / ORAL2023-05-23

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-10-15 13:18:302026-09A213466-001FEXOFENADINE HYDROCHLORIDE30MG/5MLSUSPENSION / ORAL2023-05-23c2088c7a36db…
2026-09-14 22:38:342026-08A213466-001FEXOFENADINE HYDROCHLORIDE30MG/5MLSUSPENSION / ORAL2023-05-2384e616aacf4f…
2026-08-18 06:07:402026-07A213466-001FEXOFENADINE HYDROCHLORIDE30MG/5MLSUSPENSION / ORAL2023-05-23caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A213466-001FEXOFENADINE HYDROCHLORIDE30MG/5MLSUSPENSION / ORAL2023-05-23011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A213466-001FEXOFENADINE HYDROCHLORIDE30MG/5MLSUSPENSION / ORAL2023-05-2331067a03dcf5…
2025-08-23 18:47 UTC2025-08A213466-001FEXOFENADINE HYDROCHLORIDE30MG/5MLSUSPENSION / ORAL2023-05-236a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A213466-001FEXOFENADINE HYDROCHLORIDE30MG/5MLSUSPENSION / ORAL2023-05-23fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A213466-001FEXOFENADINE HYDROCHLORIDE30MG/5MLSUSPENSION / ORAL2023-05-23b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A213466-001FEXOFENADINE HYDROCHLORIDE30MG/5MLSUSPENSION / ORAL2023-05-2303ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A213466-001FEXOFENADINE HYDROCHLORIDE30MG/5MLSUSPENSION / ORAL2023-05-232680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A213466-001FEXOFENADINE HYDROCHLORIDE30MG/5MLSUSPENSION / ORAL2023-05-235bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A213466-001FEXOFENADINE HYDROCHLORIDE30MG/5MLSUSPENSION / ORAL2023-05-23d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A213466-001FEXOFENADINE HYDROCHLORIDE30MG/5MLSUSPENSION / ORAL2023-05-23d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A213466-001FEXOFENADINE HYDROCHLORIDE30MG/5MLSUSPENSION / ORAL2023-05-2379d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A213466-001FEXOFENADINE HYDROCHLORIDE30MG/5MLSUSPENSION / ORAL2023-05-23301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A213466-001FEXOFENADINE HYDROCHLORIDE30MG/5MLSUSPENSION / ORAL2023-05-231e350fbaab3a…
2024-05-31 18:47 UTC2024-05A213466-001FEXOFENADINE HYDROCHLORIDE30MG/5MLSUSPENSION / ORAL2023-05-238072bd15b7f6…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A213466-001FEXOFENADINE HYDROCHLORIDE30MG/5MLSUSPENSION / ORAL2023-05-236a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A213466-001FEXOFENADINE HYDROCHLORIDE30MG/5MLSUSPENSION / ORAL2023-05-231c564ffb4f44…
2023-12-20 04:57 UTC2023-12A213466-001FEXOFENADINE HYDROCHLORIDE30MG/5MLSUSPENSION / ORAL2023-05-23ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A213466-001FEXOFENADINE HYDROCHLORIDE30MG/5MLSUSPENSION / ORAL2023-05-23a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A213466-001FEXOFENADINE HYDROCHLORIDE30MG/5MLSUSPENSION / ORAL2023-05-239b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A213466-001FEXOFENADINE HYDROCHLORIDE30MG/5MLSUSPENSION / ORAL2023-05-23a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A213466-001FEXOFENADINE HYDROCHLORIDE30MG/5MLSUSPENSION / ORAL2023-05-233f0d92c62455…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A213466-001FEXOFENADINE HYDROCHLORIDE30MG/5MLSUSPENSION / ORAL2023-05-23a50c72e98297…

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
FEXOFENADINE HYDROCHLORIDEFEXOFENADINE HYDROCHLORIDE ORALAurohealth LLCfe864426-c0d6-492a-96be-cd44fd9ca0542026-09-01WarningsExact identifier
ndc (package): 58602-427-24
ndc (package): 58602-427-20
ndc (product): 58602-427
ndc11 (package): 58602042720
ndc11 (package): 58602042724
spl id: fe864426-c0d6-492a-96be-cd44fd9ca054
spl set id: fe864426-c0d6-492a-96be-cd44fd9ca054

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.