Valumeds FEXOFENADINE HYDROCHLORIDE TABLETS USP 180 mg

Manufacturer
Spirit Pharmaceuticals LLC
Effective date
2024-12-13
Label type
HUMAN OTC DRUG LABEL
Version
8
Source
full-release
Hydrated at
2026-06-01 00:43:32

Label at a glance#

ProductFEXOFENADINE HYDROCHLORIDE
Active ingredientFEXOFENADINE HYDROCHLORIDE
Label structure15 sections

Indications and uses

temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:  runny nose  sneezing  itchy, watery eyes  itching of the nose or throat

Dosage and administration

 adults and children 12 years of age and over take one 180 mg tablet with water once a day; do not take more than 1 tablet in 24 hours   children under 12 years of age  do not use  adults 65 years of age and older  ask a doctor  consumers with kidney disease  ask a doctor

Label contents#

Full prescribing information#

Active ingredient (in each tablet)

OTC - ACTIVE INGREDIENT SECTION

Fexofenadine HCl 180 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  sneezing  itchy, watery eyes  itching of the nose or throat

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.

OTC - WHEN USING SECTION

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)

OTC - STOP USE SECTION

Stop use and ask a doctor if an allergic reaction to this product occurs. Seek
medical help right away. You may report side effects to FDA at 1-800-FDA-1088.

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

 adults and children 12 years of age and overtake one 180 mg tablet with water once a day; do not take more than 1 tablet in 24 hours 
 children under 12 years of age do not use
 adults 65 years of age and older ask a doctor
 consumers with kidney disease ask a doctor

OTHER SAFETY INFORMATION

Other information  safety sealed: do not use if printed foil inner
seal on bottle is torn or missing  store between 20º and 25ºC (68º
and 77ºF)  protect from excessive moisture

INACTIVE INGREDIENT SECTION

Inactive ingredients colloidal silicone dioxide, croscarmellose sodium, hypromellose,
magnesium stearate, microcrystalline cellulose, polyethylene
glycol/macrogol, povidone, pregelatinized starch, red iron oxide,
silica, titanium dioxide, yellow iron oxide.

OTC - QUESTIONS SECTION

Questions or comments? call +1-888-333-9792

SPL UNCLASSIFIED SECTION

Distributed by:
Spirit Pharmaceuticals LLC,
Ronkonkoma, NY 11779

ORG 03/19

Manufactured by:
Unique Pharmaceutical
Laboratories
(A Div. of J. B. Chemicals &
Pharmaceuticals Ltd.)
Mumbai 400 030, India
Mfg. Lic. No.: G/1430

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Valumeds™

NDC 68210-0122-1
non-drowsy
FEXOFENADINE
HYDROCHLORIDE
TABLETS USP
180 mg
antihistamine

24 Hour

indoor & outdoor allergy relief
• sneezing • runny nose
• itchy, watery eyes
• itchy nose or throat

100 tablets

Actual Size 

image descriptionimage description

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
997420fexofenadine HCl 180 MG 24 HR Oral TabletPSN8
997420fexofenadine hydrochloride 180 MG Oral TabletSCD8
997420fexofenadine HCl 180 MG 24 HR Oral TabletSY8

DailyMed Pharmacologic Classes#

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

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
b893258d-0942-3d8a-3411-056ea0788ff5Product name120140508

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68210-0122-1FEXOFENADINE HYDROCHLORIDE100 in 1 BOTTLETABLET1008
68210-0122-3FEXOFENADINE HYDROCHLORIDE30 in 1 BOTTLETABLET308
68210-0122-3FEXOFENADINE HYDROCHLORIDE1 in 1 CARTONTABLET18

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68210-0122FEXOFENADINE HYDROCHLORIDE TABLET [SPIRIT PHARMACEUTICALS LLC]8Legacy NDC, 3 package rows20241215_c18f3207-92ad-4999-99c8-b51a1edcece3.zip

Products#

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

DailyMed product names page 1 of 1 · 14 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
68210-012268210-0122-1, 68210-0122-3

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 · Source PDF

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 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A210137-001FEXOFENADINE HYDROCHLORIDE ALLERGYFEXOFENADINE HYDROCHLORIDE180MGTABLET / ORAL2018-08-13

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 2 · 43 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A210137-001FEXOFENADINE HYDROCHLORIDE ALLERGY180MGTABLET / ORAL2018-08-1384e616aacf4f…
2026-08-18 06:07:402026-07A210137-001FEXOFENADINE HYDROCHLORIDE ALLERGY180MGTABLET / ORAL2018-08-13caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A210137-001FEXOFENADINE HYDROCHLORIDE ALLERGY180MGTABLET / ORAL2018-08-13011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A210137-001FEXOFENADINE HYDROCHLORIDE ALLERGY180MGTABLET / ORAL2018-08-1331067a03dcf5…
2025-08-23 18:47 UTC2025-08A210137-001FEXOFENADINE HYDROCHLORIDE ALLERGY180MGTABLET / ORAL2018-08-136a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A210137-001FEXOFENADINE HYDROCHLORIDE ALLERGY180MGTABLET / ORAL2018-08-13fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A210137-001FEXOFENADINE HYDROCHLORIDE ALLERGY180MGTABLET / ORAL2018-08-13b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A210137-001FEXOFENADINE HYDROCHLORIDE ALLERGY180MGTABLET / ORAL2018-08-1303ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A210137-001FEXOFENADINE HYDROCHLORIDE ALLERGY180MGTABLET / ORAL2018-08-132680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A210137-001FEXOFENADINE HYDROCHLORIDE ALLERGY180MGTABLET / ORAL2018-08-135bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A210137-001FEXOFENADINE HYDROCHLORIDE ALLERGY180MGTABLET / ORAL2018-08-13d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A210137-001FEXOFENADINE HYDROCHLORIDE ALLERGY180MGTABLET / ORAL2018-08-13d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A210137-001FEXOFENADINE HYDROCHLORIDE ALLERGY180MGTABLET / ORAL2018-08-1379d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A210137-001FEXOFENADINE HYDROCHLORIDE ALLERGY180MGTABLET / ORAL2018-08-13301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A210137-001FEXOFENADINE HYDROCHLORIDE ALLERGY180MGTABLET / ORAL2018-08-131e350fbaab3a…
2024-05-31 18:47 UTC2024-05A210137-001FEXOFENADINE HYDROCHLORIDE ALLERGY180MGTABLET / ORAL2018-08-138072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A210137-001FEXOFENADINE HYDROCHLORIDE ALLERGY180MGTABLET / ORAL2018-08-135c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A210137-001FEXOFENADINE HYDROCHLORIDE ALLERGY180MGTABLET / ORAL2018-08-135d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A210137-001FEXOFENADINE HYDROCHLORIDE ALLERGY180MGTABLET / ORAL2018-08-134b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A210137-001FEXOFENADINE HYDROCHLORIDE ALLERGY180MGTABLET / ORAL2018-08-1374a2ff9319b5…
2022-03-09 01:35 UTC2022-03A210137-001FEXOFENADINE HYDROCHLORIDE ALLERGY180MGTABLET / ORAL2018-08-13bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A210137-001FEXOFENADINE HYDROCHLORIDE ALLERGY180MGTABLET / ORAL2018-08-13782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A210137-001FEXOFENADINE HYDROCHLORIDE ALLERGY180MGTABLET / ORAL2018-08-1387673890dc5c…
2021-03-12 10:30 UTC2021-03A210137-001FEXOFENADINE HYDROCHLORIDE ALLERGY180MGTABLET / ORAL2018-08-135aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A210137-001FEXOFENADINE HYDROCHLORIDE ALLERGY180MGTABLET / ORAL2018-08-138869cabd3fbd…
2020-11-12 02:37 UTC2020-11A210137-001FEXOFENADINE HYDROCHLORIDE ALLERGY180MGTABLET / ORAL2018-08-13c0c555d07b60…
2019-12-14 00:12 UTC2019-12A210137-001FEXOFENADINE HYDROCHLORIDE ALLERGY180MGTABLET / ORAL2018-08-133f01610625f2…
2019-09-15 20:21 UTC2019-09A210137-001FEXOFENADINE HYDROCHLORIDE ALLERGY180MGTABLET / ORAL2018-08-13b00525d2431f…
2019-07-19 19:46 UTC2019-07A210137-001FEXOFENADINE HYDROCHLORIDE ALLERGY180MGTABLET / ORAL2018-08-13ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A210137-001FEXOFENADINE HYDROCHLORIDE ALLERGY180MGTABLET / ORAL2018-08-136a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A210137-001FEXOFENADINE HYDROCHLORIDE ALLERGY180MGTABLET / ORAL2018-08-131c564ffb4f44…
2023-12-20 04:57 UTC2023-12A210137-001FEXOFENADINE HYDROCHLORIDE ALLERGY180MGTABLET / ORAL2018-08-13ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A210137-001FEXOFENADINE HYDROCHLORIDE ALLERGY180MGTABLET / ORAL2018-08-13a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A210137-001FEXOFENADINE HYDROCHLORIDE ALLERGY180MGTABLET / ORAL2018-08-139b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A210137-001FEXOFENADINE HYDROCHLORIDE ALLERGY180MGTABLET / ORAL2018-08-13a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A210137-001FEXOFENADINE HYDROCHLORIDE ALLERGY180MGTABLET / ORAL2018-08-133f0d92c62455…
2023-05-13 08:27 UTC2023-05A210137-001FEXOFENADINE HYDROCHLORIDE ALLERGY180MGTABLET / ORAL2018-08-13053a50430f4f…
2023-01-26 05:58 UTC2023-01A210137-001FEXOFENADINE HYDROCHLORIDE ALLERGY180MGTABLET / ORAL2018-08-133bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A210137-001FEXOFENADINE HYDROCHLORIDE ALLERGY180MGTABLET / ORAL2018-08-133a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A210137-001FEXOFENADINE HYDROCHLORIDE ALLERGY180MGTABLET / ORAL2018-08-13f41ea6bd6efb…

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
292e7312-a98d-3369-e063-6394a90a0555c18f3207-92ad-4999-99c8-b51a1edcece32024-12-13WarningsExact identifier
spl id: 292e7312-a98d-3369-e063-6394a90a0555
spl set id: c18f3207-92ad-4999-99c8-b51a1edcece3

Reported adverse events (FAERS/openFDA)#

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