Childrens Fexofenadine Hydrochloride

Manufacturer
Taro Pharmaceuticals U.S.A., Inc.
Effective date
2017-11-29
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
legacy-cache
Hydrated at
2026-08-02 01:09:29

Label at a glance#

ProductChildrens Fexofenadine Hydrochloride HIVES
Active ingredientFexofenadine Hydrochloride
Label structure11 sections

Indications and uses

reduces hives and relieves itching due to hives (urticaria). This product will not prevent hives or an allergic skin reaction from occurring.

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 6 to under 12 years of age take 5 mL every 12 hours; do not take more than 10 mL in 24 hours children under 6 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 9 mg safety sealed: do not use if carton is opened or if foil inner seal on bottle is torn or missing store between 20° and 25°C (68° and 77°F)

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient (in each 5 mL)

OTC - ACTIVE INGREDIENT SECTION

Fexofenadine HCI 30 mg

Purpose

OTC - PURPOSE SECTION

Antihistamine

Uses

INDICATIONS & USAGE SECTION

reduces hives and relieves itching due to hives (urticaria). This product will not prevent hives or an allergic skin reaction from occurring.

Warnings

WARNINGS SECTION

Severe Allergy Warning

SPL UNCLASSIFIED SECTION

Get emergency help immediately if you have hives along with any of the following symptoms:

  • swelling of tongue
  • trouble swallowing
  • swelling in or around mouth
  • trouble speaking
  • wheezing or problems breathing
  • drooling
  • dizziness or loss of consciousness

These symptoms may be signs of anaphylactic shock. This condition can be life threatening if not treated by a health professional immediately. Symptoms of anaphylactic shock may occur when hives first appear or up to a few hours later.

Not a Substitute for Epinephrine. If your doctor has prescribed an epinephrine injector for "anaphylaxis" or severe allergy symptoms that could occur with your hives, never use this product as a substitute for the epinephrine injector. If you have been prescribed an epinephrine injector, you should carry it with you at all times.

Do not use

OTC - DO NOT USE SECTION

  • to prevent hives from any known cause such as:
    • foods
    • insect stings
    • medicines
    • latex or rubber gloves
    because this product will not stop hives from occurring. Avoiding the cause of your hives is the only way to prevent them. Hives can sometimes be serious. If you do not know the cause of your hives, see your doctor for a medical exam. Your doctor may be able to help you find a cause.
  • 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.
  • hives that are an unusual color, look bruised or blistered
  • hives that do not itch

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.
  • symptoms do not improve after 3 days of treatment
  • the hives have lasted more than 6 weeks

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 6 to under 12 years of agetake 5 mL every 12 hours; do not take more than 10 mL in 24 hours
children under 6 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 9 mg
  • safety sealed: do not use if carton is opened or if foil inner seal on bottle is torn or missing
  • store between 20° and 25°C (68° and 77°F)

Inactive ingredients

INACTIVE INGREDIENT SECTION

artificial raspberry flavor, butylparaben, edetate disodium, maltitol solution, poloxamer 407, propylene glycol, propylparaben, purified water, sodium phosphate dibasic heptahydrate, sodium phosphate monobasic monohydrate, sucralose, titanium dioxide and xanthan gum

Questions?

OTC - QUESTIONS SECTION

Call 1-866-923-4914

SPL UNCLASSIFIED SECTION

Distributed by:
Taro Pharmaceuticals U.S.A., Inc.
Hawthorne, NY 10532

PRINCIPAL DISPLAY PANEL - 120 mL Bottle Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Compare to the active
ingredient in Children's
Allegra® Hives*

NDC 51672-2121-8

Children's
Fexofenadine HCI
Oral Suspension,
30 mg/ 5 mL

Antihistamine
HIVES

NON-DROWSY

Berry Flavor

Ages 6 Years
& Older

12
Hour
RELIEF OF
ITCHING DUE
TO HIVES

Dye free / Alcohol free / Sugar free

LIQUID
Oral Suspension

4 fl. oz.
(120 mL)

Principal Display Panel - 120 mL Bottle Carton
Principal Display Panel - 120 mL Bottle Carton

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
51672-212151672-2121-4, 51672-2121-8, 51672-2121-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 13 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 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
5dfc5785-e140-421f-ac22-80d90861bad6c9bd7c29-a462-43ff-9cb9-453ffa9b46ba2023-11-20WarningsExact identifier
spl set id: c9bd7c29-a462-43ff-9cb9-453ffa9b46ba

Reported adverse events (FAERS/openFDA)#

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