Allergy Relief

Manufacturer
Allegiant Health
Effective date
2021-03-23
Label type
HUMAN OTC DRUG LABEL
Version
6
Source
full-release
Hydrated at
2026-06-01 01:49:29

Label at a glance#

ProductAllergy Relief
Active ingredientFEXOFENADINE HYDROCHLORIDE
Label structure10 sections

Dosage and administration

Adults and children 12 years of age and over  take one 180 mg caplet with water, once a day; do not take more than 1 caplet 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

Storage and handling

store at room temperature 20°– 25°C (68°– 77°F)

Label contents#

Full prescribing information#

Active ingredient(s)

OTC - ACTIVE INGREDIENT SECTION

Fexofenadine HCl 180 mg

Purpose

OTC - PURPOSE SECTION

Antihistamine

Use(s)

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

OTC - DO NOT USE SECTION

if you have ever had an allergic reaction to this product or any of its ingredients

Ask a doctor before use if

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

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

Pregnancy/Breastfeeding

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a health professional before use.

Keep out of reach of children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

Adults and children 12 years of age and over  take one 180 mg caplet with water, once a day; do not take more than 1 caplet 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

SPL UNCLASSIFIED SECTION

  • protect from excessive moisture
  • do not use if imprinted seal under safety cap is broken or missing [for bottle]
  • do not use if blister unit is torn or open [for blister]

Storage

STORAGE AND HANDLING SECTION

store at room temperature 20°– 25°C (68°– 77°F)

Inactive ingredients

INACTIVE INGREDIENT SECTION

colloidal silicon dioxide, croscarmellose sodium, ferrosoferric oxide (black iron oxide),
hypromellose, iron oxide red, iron oxide yellow, lactose monohydrate, magnesium stearate,
microcrystalline cellulose, polyethylene glycol, pregelatinized starch, titanium dioxide

Questions

OTC - QUESTIONS SECTION

Call 1-888-952-0050 Monday through Friday 9AM - 5PM

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Allergy Relief
Allergy Relief

DailyMed Pharmacologic Classes#

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

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130369168416062GTIN-13: 0369168416062
EAN-13: 0369168416062
GTIN-12: 369168416062
UPC-A: 369168416062
GTIN storage (14 digits): 00369168416062
413---allery-relief-1.jpg

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
69168-413-03Allergy Relief3 in 1 CARTONCAPSULE, COATED36
69168-413-06Allergy Relief120 in 1 BOTTLECAPSULE, COATED1206
69168-413-14Allergy Relief250 in 1 BOTTLECAPSULE, COATED2506
69168-413-30Allergy Relief30 in 1 BOTTLECAPSULE, COATED306
69168-413-80Allergy Relief180 in 1 BOTTLECAPSULE, COATED1806
69168-413-82Allergy Relief90 in 1 BOTTLECAPSULE, COATED906

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
69168-41369168-413-03, 69168-413-06, 69168-413-30, 69168-413-82, 69168-413-80, 69168-413-14

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
A211075-001FEXOFENADINE HYDROCHLORIDE ALLERGYFEXOFENADINE HYDROCHLORIDE60MGTABLET / ORAL2019-10-18
A211075-002FEXOFENADINE HYDROCHLORIDE ALLERGYFEXOFENADINE HYDROCHLORIDE180MGTABLET / ORAL2019-10-18

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 · 82 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A211075-001FEXOFENADINE HYDROCHLORIDE ALLERGY60MGTABLET / ORAL2019-10-1884e616aacf4f…
2026-09-14 22:38:342026-08A211075-002FEXOFENADINE HYDROCHLORIDE ALLERGY180MGTABLET / ORAL2019-10-1884e616aacf4f…
2026-08-18 06:07:402026-07A211075-001FEXOFENADINE HYDROCHLORIDE ALLERGY60MGTABLET / ORAL2019-10-18caaa826d4ba7…
2026-08-18 06:07:402026-07A211075-002FEXOFENADINE HYDROCHLORIDE ALLERGY180MGTABLET / ORAL2019-10-18caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A211075-001FEXOFENADINE HYDROCHLORIDE ALLERGY60MGTABLET / ORAL2019-10-18011fe1cb6892…
2026-02-19 14:30 UTC2026-02A211075-002FEXOFENADINE HYDROCHLORIDE ALLERGY180MGTABLET / ORAL2019-10-18011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A211075-001FEXOFENADINE HYDROCHLORIDE ALLERGY60MGTABLET / ORAL2019-10-1831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A211075-002FEXOFENADINE HYDROCHLORIDE ALLERGY180MGTABLET / ORAL2019-10-1831067a03dcf5…
2025-08-23 18:47 UTC2025-08A211075-001FEXOFENADINE HYDROCHLORIDE ALLERGY60MGTABLET / ORAL2019-10-186a471c1ec25d…
2025-08-23 18:47 UTC2025-08A211075-002FEXOFENADINE HYDROCHLORIDE ALLERGY180MGTABLET / ORAL2019-10-186a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A211075-001FEXOFENADINE HYDROCHLORIDE ALLERGY60MGTABLET / ORAL2019-10-18fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A211075-002FEXOFENADINE HYDROCHLORIDE ALLERGY180MGTABLET / ORAL2019-10-18fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A211075-001FEXOFENADINE HYDROCHLORIDE ALLERGY60MGTABLET / ORAL2019-10-18b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A211075-002FEXOFENADINE HYDROCHLORIDE ALLERGY180MGTABLET / ORAL2019-10-18b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A211075-001FEXOFENADINE HYDROCHLORIDE ALLERGY60MGTABLET / ORAL2019-10-1803ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A211075-002FEXOFENADINE HYDROCHLORIDE ALLERGY180MGTABLET / ORAL2019-10-1803ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A211075-001FEXOFENADINE HYDROCHLORIDE ALLERGY60MGTABLET / ORAL2019-10-182680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A211075-002FEXOFENADINE HYDROCHLORIDE ALLERGY180MGTABLET / ORAL2019-10-182680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A211075-001FEXOFENADINE HYDROCHLORIDE ALLERGY60MGTABLET / ORAL2019-10-185bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A211075-002FEXOFENADINE HYDROCHLORIDE ALLERGY180MGTABLET / ORAL2019-10-185bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A211075-001FEXOFENADINE HYDROCHLORIDE ALLERGY60MGTABLET / ORAL2019-10-18d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A211075-002FEXOFENADINE HYDROCHLORIDE ALLERGY180MGTABLET / ORAL2019-10-18d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A211075-001FEXOFENADINE HYDROCHLORIDE ALLERGY60MGTABLET / ORAL2019-10-18d06236e962d9…
2024-10-29 15:01 UTC2024-10A211075-002FEXOFENADINE HYDROCHLORIDE ALLERGY180MGTABLET / ORAL2019-10-18d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A211075-001FEXOFENADINE HYDROCHLORIDE ALLERGY60MGTABLET / ORAL2019-10-1879d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A211075-002FEXOFENADINE HYDROCHLORIDE ALLERGY180MGTABLET / ORAL2019-10-1879d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A211075-001FEXOFENADINE HYDROCHLORIDE ALLERGY60MGTABLET / ORAL2019-10-18301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A211075-002FEXOFENADINE HYDROCHLORIDE ALLERGY180MGTABLET / ORAL2019-10-18301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A211075-001FEXOFENADINE HYDROCHLORIDE ALLERGY60MGTABLET / ORAL2019-10-181e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A211075-002FEXOFENADINE HYDROCHLORIDE ALLERGY180MGTABLET / ORAL2019-10-181e350fbaab3a…
2024-05-31 18:47 UTC2024-05A211075-001FEXOFENADINE HYDROCHLORIDE ALLERGY60MGTABLET / ORAL2019-10-188072bd15b7f6…
2024-05-31 18:47 UTC2024-05A211075-002FEXOFENADINE HYDROCHLORIDE ALLERGY180MGTABLET / ORAL2019-10-188072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A211075-001FEXOFENADINE HYDROCHLORIDE ALLERGY60MGTABLET / ORAL2019-10-185c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A211075-002FEXOFENADINE HYDROCHLORIDE ALLERGY180MGTABLET / ORAL2019-10-185c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A211075-001FEXOFENADINE HYDROCHLORIDE ALLERGY60MGTABLET / ORAL2019-10-185d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A211075-002FEXOFENADINE HYDROCHLORIDE ALLERGY180MGTABLET / ORAL2019-10-185d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A211075-001FEXOFENADINE HYDROCHLORIDE ALLERGY60MGTABLET / ORAL2019-10-184b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A211075-002FEXOFENADINE HYDROCHLORIDE ALLERGY180MGTABLET / ORAL2019-10-184b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A211075-001FEXOFENADINE HYDROCHLORIDE ALLERGY60MGTABLET / ORAL2019-10-1874a2ff9319b5…
2019-12-13 00:20 UTC2019-12A211075-002FEXOFENADINE HYDROCHLORIDE ALLERGY180MGTABLET / ORAL2019-10-1874a2ff9319b5…

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
Allergy ReliefFEXOFENADINE HCLAllegiant Health25e72bd3-25c6-4943-92bb-27f9543e2d8a2021-03-23WarningsExact identifier
ndc (package): 69168-413-80
ndc (package): 69168-413-14
ndc (package): 69168-413-03
ndc (package): 69168-413-82
ndc (package): 69168-413-30
ndc (package): 69168-413-06
ndc (product): 69168-413
ndc11 (package): 69168041314
ndc11 (package): 69168041330
ndc11 (package): 69168041380
ndc11 (package): 69168041303
ndc11 (package): 69168041306
ndc11 (package): 69168041382
spl id: 706fa553-a089-4d9b-8e40-f814a6c4dc75
spl set id: 25e72bd3-25c6-4943-92bb-27f9543e2d8a

Reported adverse events (FAERS/openFDA)#

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