FDA.reportPublic FDA data

Childrens Fexofenadine Hydrochloride

Manufacturer
Wal-Mart Stores Inc | Taro Pharmaceutical Industries Ltd.
Effective date
2024-12-06
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 00:47:01

Label at a glance#

ProductChildrens Fexofenadine Hydrochloride Allergy
Active ingredientFEXOFENADINE HYDROCHLORIDE
Label structure11 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 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...

Storage and handling

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)

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient (in each 5 mL)

OTC - ACTIVE INGREDIENT SECTION

Fexofenadine HCl 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

OTC - DO NOT USE SECTION

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

OTC - ASK DOCTOR SECTION

Ask a doctor before use if you have 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)

OTC - STOP USE SECTION

Stop use and ask a doctor if 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.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

  • shake well before using
  • use only with enclosed dosing cup
Note: mL = milliliters
adults and children 12 years of age and overtake 10 mL every 12 hours; do not take more than 20 mL in 24 hours
children 2 to under 12 years of agetake 5 mL every 12 hours; do not take more than 10 mL in 24 hours
children under 2 years of ageask a doctor
adults 65 years of age and olderask a doctor
consumers with kidney diseaseask a doctor

Other information

STORAGE AND HANDLING SECTION

  • 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 INGREDIENT SECTION

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

Questions?

OTC - QUESTIONS SECTION

Call 1-888-287-1915

SPL UNCLASSIFIED SECTION

DISTRIBUTED BY: Walmart Inc.,
Bentonville, AR 72716

PRINCIPAL DISPLAY PANEL - 120 mL Bottle Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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)

CartonCarton

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
997491fexofenadine HCl 30 MG in 5 mL Oral SuspensionPSN2
997491fexofenadine hydrochloride 6 MG/ML Oral SuspensionSCD2
997491fexofenadine HCl 30 MG per 5 ML Oral SuspensionSY2

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
FEXOFENADINE Pharmacologic Class Indexing3Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
726062af-1135-4707-a1d7-57256991bbf9Product name220250226
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717
19c71a3d-ed9c-166b-a7e5-38c250c35631Product name120140508
b893258d-0942-3d8a-3411-056ea0788ff5Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
79903-306-04Childrens Fexofenadine HydrochlorideAllergy120 mL in 1 BOTTLESUSPENSION1202
79903-306-04Childrens Fexofenadine HydrochlorideAllergy1 in 1 CARTONSUSPENSION12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
79903-306CHILDRENS FEXOFENADINE HYDROCHLORIDE ALLERGY (FEXOFENADINE HYDROCHLORIDE) SUSPENSION [WAL-MART STORES INC]2Current NDC, 2 package rows20241222_2432f862-6d7e-666d-e063-6294a90acf74.zip

Products#

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

DailyMed product names page 1 of 1 · 15 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
79903-30679903-306-04

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 13 matching rows.

Name, UNII, Kind table
NameUNIIKind
EDETATE DISODIUM7FLD91C86KIACT
MALTITOLD65DG142WKIACT
POLOXAMER 407TUF2IVW3M2IACT
PROPYLENE GLYCOL6DC9Q167V3IACT
WATER059QF0KO0RIACT
SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE70WT22SF4BIACT
SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE593YOG76RNIACT
SUCRALOSE96K6UQ3ZD4IACT
POTASSIUM SORBATE1VPU26JZZ4IACT
TITANIUM DIOXIDE15FIX9V2JPIACT
XANTHAN GUMTTV12P4NEEIACT
SODIUM BENZOATEOJ245FE5EUIACT
FEXOFENADINE HYDROCHLORIDE2S068B75ZUACTIB

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 43.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A208123-001CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGYFEXOFENADINE HYDROCHLORIDE30MG/5MLSUSPENSION / ORAL2017-11-09
A208123-002CHILDREN'S FEXOFENADINE HYDROCHLORIDE HIVESFEXOFENADINE HYDROCHLORIDE30MG/5MLSUSPENSION / ORAL2017-11-09

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.

Product history page 1 of 3 · 86 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A208123-001CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY30MG/5MLSUSPENSION / ORAL2017-11-0984e616aacf4f…
2026-09-14 22:38:342026-08A208123-002CHILDREN'S FEXOFENADINE HYDROCHLORIDE HIVES30MG/5MLSUSPENSION / ORAL2017-11-0984e616aacf4f…
2026-08-18 06:07:402026-07A208123-001CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY30MG/5MLSUSPENSION / ORAL2017-11-09caaa826d4ba7…
2026-08-18 06:07:402026-07A208123-002CHILDREN'S FEXOFENADINE HYDROCHLORIDE HIVES30MG/5MLSUSPENSION / ORAL2017-11-09caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A208123-001CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY30MG/5MLSUSPENSION / ORAL2017-11-09011fe1cb6892…
2026-02-19 14:30 UTC2026-02A208123-002CHILDREN'S FEXOFENADINE HYDROCHLORIDE HIVES30MG/5MLSUSPENSION / ORAL2017-11-09011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A208123-001CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY30MG/5MLSUSPENSION / ORAL2017-11-0931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A208123-002CHILDREN'S FEXOFENADINE HYDROCHLORIDE HIVES30MG/5MLSUSPENSION / ORAL2017-11-0931067a03dcf5…
2025-08-23 18:47 UTC2025-08A208123-001CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY30MG/5MLSUSPENSION / ORAL2017-11-096a471c1ec25d…
2025-08-23 18:47 UTC2025-08A208123-002CHILDREN'S FEXOFENADINE HYDROCHLORIDE HIVES30MG/5MLSUSPENSION / ORAL2017-11-096a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A208123-001CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY30MG/5MLSUSPENSION / ORAL2017-11-09fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A208123-002CHILDREN'S FEXOFENADINE HYDROCHLORIDE HIVES30MG/5MLSUSPENSION / ORAL2017-11-09fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A208123-001CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY30MG/5MLSUSPENSION / ORAL2017-11-09b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A208123-002CHILDREN'S FEXOFENADINE HYDROCHLORIDE HIVES30MG/5MLSUSPENSION / ORAL2017-11-09b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A208123-001CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY30MG/5MLSUSPENSION / ORAL2017-11-0903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A208123-002CHILDREN'S FEXOFENADINE HYDROCHLORIDE HIVES30MG/5MLSUSPENSION / ORAL2017-11-0903ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A208123-001CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY30MG/5MLSUSPENSION / ORAL2017-11-092680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A208123-002CHILDREN'S FEXOFENADINE HYDROCHLORIDE HIVES30MG/5MLSUSPENSION / ORAL2017-11-092680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A208123-001CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY30MG/5MLSUSPENSION / ORAL2017-11-095bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A208123-002CHILDREN'S FEXOFENADINE HYDROCHLORIDE HIVES30MG/5MLSUSPENSION / ORAL2017-11-095bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A208123-001CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY30MG/5MLSUSPENSION / ORAL2017-11-09d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A208123-002CHILDREN'S FEXOFENADINE HYDROCHLORIDE HIVES30MG/5MLSUSPENSION / ORAL2017-11-09d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A208123-001CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY30MG/5MLSUSPENSION / ORAL2017-11-09d06236e962d9…
2024-10-29 15:01 UTC2024-10A208123-002CHILDREN'S FEXOFENADINE HYDROCHLORIDE HIVES30MG/5MLSUSPENSION / ORAL2017-11-09d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A208123-001CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY30MG/5MLSUSPENSION / ORAL2017-11-0979d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A208123-002CHILDREN'S FEXOFENADINE HYDROCHLORIDE HIVES30MG/5MLSUSPENSION / ORAL2017-11-0979d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A208123-001CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY30MG/5MLSUSPENSION / ORAL2017-11-09301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A208123-002CHILDREN'S FEXOFENADINE HYDROCHLORIDE HIVES30MG/5MLSUSPENSION / ORAL2017-11-09301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A208123-001CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY30MG/5MLSUSPENSION / ORAL2017-11-091e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A208123-002CHILDREN'S FEXOFENADINE HYDROCHLORIDE HIVES30MG/5MLSUSPENSION / ORAL2017-11-091e350fbaab3a…
2024-05-31 18:47 UTC2024-05A208123-001CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY30MG/5MLSUSPENSION / ORAL2017-11-098072bd15b7f6…
2024-05-31 18:47 UTC2024-05A208123-002CHILDREN'S FEXOFENADINE HYDROCHLORIDE HIVES30MG/5MLSUSPENSION / ORAL2017-11-098072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A208123-001CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY30MG/5MLSUSPENSION / ORAL2017-11-095c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A208123-002CHILDREN'S FEXOFENADINE HYDROCHLORIDE HIVES30MG/5MLSUSPENSION / ORAL2017-11-095c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A208123-001CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY30MG/5MLSUSPENSION / ORAL2017-11-095d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A208123-002CHILDREN'S FEXOFENADINE HYDROCHLORIDE HIVES30MG/5MLSUSPENSION / ORAL2017-11-095d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A208123-001CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY30MG/5MLSUSPENSION / ORAL2017-11-094b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A208123-002CHILDREN'S FEXOFENADINE HYDROCHLORIDE HIVES30MG/5MLSUSPENSION / ORAL2017-11-094b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A208123-001CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY30MG/5MLSUSPENSION / ORAL2017-11-0974a2ff9319b5…
2019-12-13 00:20 UTC2019-12A208123-002CHILDREN'S FEXOFENADINE HYDROCHLORIDE HIVES30MG/5MLSUSPENSION / ORAL2017-11-0974a2ff9319b5…

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
Childrens Fexofenadine Hydrochloride AllergyFEXOFENADINE HYDROCHLORIDEWal-Mart Stores Inc2432f862-6d7e-666d-e063-6294a90acf742024-12-06WarningsExact identifier
ndc (package): 79903-306-04
ndc (product): 79903-306
ndc11 (package): 79903030604
spl id: 2905c49e-1ab8-3d84-e063-6394a90ac1a4
spl set id: 2432f862-6d7e-666d-e063-6294a90acf74

Reported adverse events (FAERS/openFDA)#

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