Nuvicare Hives Relief

Manufacturer
NUVICARE LLC
Effective date
2026-01-21
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 01:34:20

Label at a glance#

ProductNuvicare Hives Relief
Active ingredientFEXOFENADINE HYDROCHLORIDE
Label structure15 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

adults and children 12 years of age and over: take one 180mg 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 caplet)

OTC - ACTIVE INGREDIENT SECTION

Fexofenadine HCl 180 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:
Get emergency help immediately if you have hives along with any of the following symptoms:
■trouble swallowing
■dizziness or loss of consciousness
■swelling of tongue
■swelling in or around mouth
■trouble speaking
■drooling
■wheezing or problems breathing

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

adults and children 12 years of age and over: take one 180mg 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 information

OTHER SAFETY INFORMATION

■ Store between 20°C and 25 °C (68 °and 77°F)
■ Protect from excessive moisture

Inactive ingredient

INACTIVE INGREDIENT SECTION

Colloidal Silicon Dioxide, Croscarmellose Sodium Hypromellose, Magnesium Stearate, Microcrystalline Cellulose, Polyethylene Glycol/macrogol, Povidone, Pregelatinized Starch, Red iron oxide, Silica, Titanium dioxide, Yellow iron oxide.

Questions or comments

OTC - QUESTIONS SECTION

Call 1 (718) 337-8733 or email: support@nuvicare.com

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PL0281-00 NC-Hives Relief-Fexo 30ct-signedPL0281-00 NC-Hives Relief-Fexo 30ct-signed

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
997420fexofenadine HCl 180 MG 24 HR Oral TabletPSN1
997420fexofenadine hydrochloride 180 MG Oral TabletSCD1
997420fexofenadine HCl 180 MG 24 HR Oral TabletSY1

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
84324-031-01Nuvicare Hives Relief30 in 1 BOTTLETABLET301

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
84324-03184324-031-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 12 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
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 · 44 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-10-15 13:18:302026-09A210137-001FEXOFENADINE HYDROCHLORIDE ALLERGY180MGTABLET / ORAL2018-08-13c2088c7a36db…
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…

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
Nuvicare Hives ReliefFEXOFENADINE HYDROCHLORIDENUVICARE LLCa8e11094-ca69-488d-a720-b8129f17f5052026-01-21WarningsExact identifier
ndc (package): 84324-031-01
ndc (product): 84324-031
ndc11 (package): 84324003101
spl id: 8a758eab-e855-4cac-85e1-c7df0aa2150d
spl set id: a8e11094-ca69-488d-a720-b8129f17f505

Reported adverse events (FAERS/openFDA)#

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