FEXOFENADINE HYDROCHLORIDE TABLETS USP, 60mg and 180 mg Allergy

Manufacturer
Camber Consumer Care
Effective date
2023-11-06
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-05-31 23:59:14

Label at a glance#

ProductFexofenadine HCl
Active ingredientFEXOFENADINE HYDROCHLORIDE
Label structure10 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

FOR 60mg adults and children 12 years of age and over take two 60mg tablets with water evrery 12 hours; do not take more than 2 tablets 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 FOR 180mg 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 h...

Label contents#

Full prescribing information#

ALLERGYActive ingredient (in each film-coated tablet)

OTC - ACTIVE INGREDIENT SECTION

Fexofenadine HCl USP, 60mg and 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
  • 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 you have

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

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

If pregnant or breast-feeding,

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 overdose, get medical help or contact a Poison Control Center right away (1800-222-1222).

Directions

DOSAGE & ADMINISTRATION SECTION

FOR 60mg
adults and children 12 years of age and overtake two 60mg tablets with water evrery 12 hours; do not take more than 2 tablets in 24 hours
children under 12 years of agedo not use
adults 65 years of age and olderask a doctor
consumers with kidney diseaseask a doctor
FOR 180mg
adults and children 12 years of age and overtake 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

SPL UNCLASSIFIED SECTION

  • safety sealed: do not use if carton is opened or if printed foil inner seal on bottle is torn or missing
  • store between 20° and 25°C (68° and 77°F)
  • protect from excessive moisture
  • each tablet contains: sodium 8.2 mg (for 180mg)
  • each tablet contains: sodium 2.7 mg (for 60mg)
  • this product meets the requirements of USP Dissolution Test 2

Inactive ingredients

INACTIVE INGREDIENT SECTION

anhydrous lactose, colloidal silicon dioxide, corn starch, croscarmellose sodium, lactose monohydrate, pregelatinized starch (maize), stearic acid, opadry pink 03B84893 containing hypromellose, polyethylene glycol, red iron oxide, titanium dioxide and yellow iron oxide.

Questions or comments?

OTC - QUESTIONS SECTION

Call 1-888-588-1418

Distributed by:
Camber Consumer Care, Inc.
Piscataway, NJ 08854, USA,

Made in USA

Camber Consumer Care - Compare to the active ingredient in Allegra® Allergy 24 Hour Tablets Allergy Relief - 24 HOUR FEXOFENADINE HYDROCHLORIDE TABLETS USP, 180 mg Antihistamine Indoor & Outdoor Allergies

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

180 mg180 mg

CAMBER CONSUMER CARE

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 69230-201-01 Compare to the active ingredient in Allegra® Allergy*

Non-Drowsy

Fexofenadine Hydrochloride Tablets USP

60 mg

Antihistamine

12 HR Indoor/Outdoor Allergy Relief

Sneezing
Runny Nose
Itchy, Watery Eyes
Itchy Nose or Throat

Fexo-60mg-allergy-100sFexo-60mg-allergy-100s

NDC 69230-201-05 Compare to the active ingredient in Allegra® Allergy*

Non-Drowsy

Fexofenadine Hydrochloride Tablets USP

60 mg

Antihistamine

12 HR Indoor/Outdoor Allergy Relief

  • Sneezing
  • Runny Nose
  • Itchy, Watery Eyes
  • Itchy Nose or Throat

60 mg60 mg

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
997420fexofenadine HCl 180 MG 24 HR Oral TabletPSN3
997501fexofenadine HCl 60 MG Oral TabletPSN3
997420fexofenadine hydrochloride 180 MG Oral TabletSCD3
997501fexofenadine hydrochloride 60 MG Oral TabletSCD3
997420fexofenadine HCl 180 MG 24 HR Oral TabletSY3

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#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
69230-202-012021-12-13C16284748780-19d75b9cf-d11b-f424-e053-dadaa90a57ceFEXOFENADINE HYDROCHLORIDE TABLETS USP, 60mg and 180 mg Allergy
69230-202-052021-12-13C16284748780-19d75b9cf-d11b-f424-e053-dadaa90a57ceFEXOFENADINE HYDROCHLORIDE TABLETS USP, 60mg and 180 mg Allergy
69230-202-112021-12-13C16284748780-19d75b9cf-d11b-f424-e053-dadaa90a57ceFEXOFENADINE HYDROCHLORIDE TABLETS USP, 60mg and 180 mg Allergy
69230-202-302021-12-13C16284748780-19d75b9cf-d11b-f424-e053-dadaa90a57ceFEXOFENADINE HYDROCHLORIDE TABLETS USP, 60mg and 180 mg Allergy
69230-202-452021-12-13C16284748780-19d75b9cf-d11b-f424-e053-dadaa90a57ceFEXOFENADINE HYDROCHLORIDE TABLETS USP, 60mg and 180 mg Allergy
69230-202-602021-12-13C16284748780-19d75b9cf-d11b-f424-e053-dadaa90a57ceFEXOFENADINE HYDROCHLORIDE TABLETS USP, 60mg and 180 mg Allergy
69230-202-902021-12-13C16284748780-19d75b9cf-d11b-f424-e053-dadaa90a57ceFEXOFENADINE HYDROCHLORIDE TABLETS USP, 60mg and 180 mg Allergy
69230-202-012020-01-31C16284748780-19d75b9cf-d11b-f424-e053-dadaa90a57ceFEXOFENADINE HYDROCHLORIDE TABLETS USP, 60mg and 180 mg Allergy
69230-202-052020-01-31C16284748780-19d75b9cf-d11b-f424-e053-dadaa90a57ceFEXOFENADINE HYDROCHLORIDE TABLETS USP, 60mg and 180 mg Allergy
69230-202-112020-01-31C16284748780-19d75b9cf-d11b-f424-e053-dadaa90a57ceFEXOFENADINE HYDROCHLORIDE TABLETS USP, 60mg and 180 mg Allergy
69230-202-302020-01-31C16284748780-19d75b9cf-d11b-f424-e053-dadaa90a57ceFEXOFENADINE HYDROCHLORIDE TABLETS USP, 60mg and 180 mg Allergy
69230-202-452020-01-31C16284748780-19d75b9cf-d11b-f424-e053-dadaa90a57ceFEXOFENADINE HYDROCHLORIDE TABLETS USP, 60mg and 180 mg Allergy
69230-202-602020-01-31C16284748780-19d75b9cf-d11b-f424-e053-dadaa90a57ceFEXOFENADINE HYDROCHLORIDE TABLETS USP, 60mg and 180 mg Allergy
69230-202-902020-01-31C16284748780-19d75b9cf-d11b-f424-e053-dadaa90a57ceFEXOFENADINE HYDROCHLORIDE TABLETS USP, 60mg and 180 mg Allergy

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69230-201-01Fexofenadine HCl100 in 1 BOTTLETABLET, FILM COATED1003
69230-201-05Fexofenadine HCl500 in 1 BOTTLETABLET, FILM COATED5003
69230-202-01Fexofenadine HCl100 in 1 BOTTLETABLET, FILM COATED1003
69230-202-01Fexofenadine HCl1 in 1 CARTONTABLET, FILM COATED13
69230-202-05Fexofenadine HCl500 in 1 BOTTLETABLET, FILM COATED5003
69230-202-11Fexofenadine HCl1000 in 1 BOTTLETABLET, FILM COATED10003
69230-202-30Fexofenadine HCl30 in 1 BOTTLETABLET, FILM COATED303
69230-202-30Fexofenadine HCl1 in 1 CARTONTABLET, FILM COATED13
69230-202-45Fexofenadine HCl1 in 1 CARTONTABLET, FILM COATED13
69230-202-45Fexofenadine HCl45 in 1 BOTTLETABLET, FILM COATED453
69230-202-60Fexofenadine HCl1 in 1 CARTONTABLET, FILM COATED13
69230-202-60Fexofenadine HCl60 in 1 BOTTLETABLET, FILM COATED603
69230-202-90Fexofenadine HCl90 in 1 BOTTLETABLET, FILM COATED903
69230-202-90Fexofenadine HCl1 in 1 CARTONTABLET, FILM COATED13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69230-201FEXOFENADINE HCL TABLET, FILM COATED [CAMBER CONSUMER CARE]3Current NDC, Legacy NDC, 2 package rows20231108_1bb1bea3-b17d-4326-b037-7468add0df80.zip
69230-202FEXOFENADINE HCL TABLET, FILM COATED [CAMBER CONSUMER CARE]3Current NDC, Legacy NDC, 12 package rows20231108_1bb1bea3-b17d-4326-b037-7468add0df80.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
69230-202-01EA - Each69230-20283484e5c-4840-461c-91cb-f7f8b309cbd612018-02-20
69230-202-30EA - Each69230-2020bfc5135-5b54-4d96-b2ed-9bdac16e063712018-02-20
69230-202-60EA - Each69230-2024e8881ff-d9f4-4224-b74c-f9ef0e3d3e4b12020-07-13
69230-201-01EA - Each69230-201d28ade0f-555a-41bf-8706-88c5cd34a48f12024-09-09
69230-201-05EA - Each69230-2012c03c8a2-d2f2-4e1d-bd18-93294b653a4e12022-01-06

Products#

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

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

NDC Codes#

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 24 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 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A204507-002FEXOFENADINE HYDROCHLORIDE ALLERGYFEXOFENADINE HYDROCHLORIDE60MGTABLET / ORAL2015-09-16
A204507-003FEXOFENADINE HYDROCHLORIDE ALLERGYFEXOFENADINE HYDROCHLORIDE180MGTABLET / ORAL2015-09-16
A204507-004FEXOFENADINE HYDROCHLORIDE HIVESFEXOFENADINE HYDROCHLORIDE60MGTABLET / ORAL2015-09-16
A204507-005FEXOFENADINE HYDROCHLORIDE HIVESFEXOFENADINE HYDROCHLORIDE180MGTABLET / ORAL2015-09-16

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 5 · 176 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-10-15 13:18:302026-09A204507-002FEXOFENADINE HYDROCHLORIDE ALLERGY60MGTABLET / ORAL2015-09-16c2088c7a36db…
2026-10-15 13:18:302026-09A204507-003FEXOFENADINE HYDROCHLORIDE ALLERGY180MGTABLET / ORAL2015-09-16c2088c7a36db…
2026-10-15 13:18:302026-09A204507-004FEXOFENADINE HYDROCHLORIDE HIVES60MGTABLET / ORAL2015-09-16c2088c7a36db…
2026-10-15 13:18:302026-09A204507-005FEXOFENADINE HYDROCHLORIDE HIVES180MGTABLET / ORAL2015-09-16c2088c7a36db…
2026-09-14 22:38:342026-08A204507-002FEXOFENADINE HYDROCHLORIDE ALLERGY60MGTABLET / ORAL2015-09-1684e616aacf4f…
2026-09-14 22:38:342026-08A204507-003FEXOFENADINE HYDROCHLORIDE ALLERGY180MGTABLET / ORAL2015-09-1684e616aacf4f…
2026-09-14 22:38:342026-08A204507-004FEXOFENADINE HYDROCHLORIDE HIVES60MGTABLET / ORAL2015-09-1684e616aacf4f…
2026-09-14 22:38:342026-08A204507-005FEXOFENADINE HYDROCHLORIDE HIVES180MGTABLET / ORAL2015-09-1684e616aacf4f…
2026-08-18 06:07:402026-07A204507-002FEXOFENADINE HYDROCHLORIDE ALLERGY60MGTABLET / ORAL2015-09-16caaa826d4ba7…
2026-08-18 06:07:402026-07A204507-003FEXOFENADINE HYDROCHLORIDE ALLERGY180MGTABLET / ORAL2015-09-16caaa826d4ba7…
2026-08-18 06:07:402026-07A204507-004FEXOFENADINE HYDROCHLORIDE HIVES60MGTABLET / ORAL2015-09-16caaa826d4ba7…
2026-08-18 06:07:402026-07A204507-005FEXOFENADINE HYDROCHLORIDE HIVES180MGTABLET / ORAL2015-09-16caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A204507-002FEXOFENADINE HYDROCHLORIDE ALLERGY60MGTABLET / ORAL2015-09-16011fe1cb6892…
2026-02-19 14:30 UTC2026-02A204507-003FEXOFENADINE HYDROCHLORIDE ALLERGY180MGTABLET / ORAL2015-09-16011fe1cb6892…
2026-02-19 14:30 UTC2026-02A204507-004FEXOFENADINE HYDROCHLORIDE HIVES60MGTABLET / ORAL2015-09-16011fe1cb6892…
2026-02-19 14:30 UTC2026-02A204507-005FEXOFENADINE HYDROCHLORIDE HIVES180MGTABLET / ORAL2015-09-16011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A204507-002FEXOFENADINE HYDROCHLORIDE ALLERGY60MGTABLET / ORAL2015-09-1631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A204507-003FEXOFENADINE HYDROCHLORIDE ALLERGY180MGTABLET / ORAL2015-09-1631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A204507-004FEXOFENADINE HYDROCHLORIDE HIVES60MGTABLET / ORAL2015-09-1631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A204507-005FEXOFENADINE HYDROCHLORIDE HIVES180MGTABLET / ORAL2015-09-1631067a03dcf5…
2025-08-23 18:47 UTC2025-08A204507-002FEXOFENADINE HYDROCHLORIDE ALLERGY60MGTABLET / ORAL2015-09-166a471c1ec25d…
2025-08-23 18:47 UTC2025-08A204507-003FEXOFENADINE HYDROCHLORIDE ALLERGY180MGTABLET / ORAL2015-09-166a471c1ec25d…
2025-08-23 18:47 UTC2025-08A204507-004FEXOFENADINE HYDROCHLORIDE HIVES60MGTABLET / ORAL2015-09-166a471c1ec25d…
2025-08-23 18:47 UTC2025-08A204507-005FEXOFENADINE HYDROCHLORIDE HIVES180MGTABLET / ORAL2015-09-166a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A204507-002FEXOFENADINE HYDROCHLORIDE ALLERGY60MGTABLET / ORAL2015-09-16fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A204507-003FEXOFENADINE HYDROCHLORIDE ALLERGY180MGTABLET / ORAL2015-09-16fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A204507-004FEXOFENADINE HYDROCHLORIDE HIVES60MGTABLET / ORAL2015-09-16fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A204507-005FEXOFENADINE HYDROCHLORIDE HIVES180MGTABLET / ORAL2015-09-16fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A204507-002FEXOFENADINE HYDROCHLORIDE ALLERGY60MGTABLET / ORAL2015-09-16b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A204507-003FEXOFENADINE HYDROCHLORIDE ALLERGY180MGTABLET / ORAL2015-09-16b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A204507-004FEXOFENADINE HYDROCHLORIDE HIVES60MGTABLET / ORAL2015-09-16b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A204507-005FEXOFENADINE HYDROCHLORIDE HIVES180MGTABLET / ORAL2015-09-16b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A204507-002FEXOFENADINE HYDROCHLORIDE ALLERGY60MGTABLET / ORAL2015-09-1603ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A204507-003FEXOFENADINE HYDROCHLORIDE ALLERGY180MGTABLET / ORAL2015-09-1603ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A204507-004FEXOFENADINE HYDROCHLORIDE HIVES60MGTABLET / ORAL2015-09-1603ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A204507-005FEXOFENADINE HYDROCHLORIDE HIVES180MGTABLET / ORAL2015-09-1603ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A204507-002FEXOFENADINE HYDROCHLORIDE ALLERGY60MGTABLET / ORAL2015-09-162680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A204507-003FEXOFENADINE HYDROCHLORIDE ALLERGY180MGTABLET / ORAL2015-09-162680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A204507-004FEXOFENADINE HYDROCHLORIDE HIVES60MGTABLET / ORAL2015-09-162680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A204507-005FEXOFENADINE HYDROCHLORIDE HIVES180MGTABLET / ORAL2015-09-162680178bc6a6…

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
Fexofenadine HClFEXOFENADINE HCLCamber Consumer Care1bb1bea3-b17d-4326-b037-7468add0df802023-11-06WarningsExact identifier
ndc (package): 69230-202-90
ndc (package): 69230-202-60
ndc (package): 69230-202-01
ndc (package): 69230-202-05
ndc (package): 69230-201-01
ndc (package): 69230-202-30
ndc (package): 69230-201-05
ndc (package): 69230-202-45
ndc (package): 69230-202-11
ndc (product): 69230-201
ndc (product): 69230-202
ndc11 (package): 69230020205
ndc11 (package): 69230020201
ndc11 (package): 69230020230
ndc11 (package): 69230020260
ndc11 (package): 69230020290
ndc11 (package): 69230020101
ndc11 (package): 69230020245
ndc11 (package): 69230020105
ndc11 (package): 69230020211
spl id: 09845f21-f05e-34b2-e063-6394a90a7677
spl set id: 1bb1bea3-b17d-4326-b037-7468add0df80

Reported adverse events (FAERS/openFDA)#

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