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
fexofenadine hcl
- Manufacturer
- ScieGen Pharmaceuticals, Inc.
- Effective date
- 2024-12-24
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 8
- Source
- full-release
- Hydrated at
- 2026-06-01 00:48:43
Label at a glance#
Productfexofenadine hcl
Active ingredientFEXOFENADINE HYDROCHLORIDE
Label structure27 sections
Dosage and administration
adults and children 12 years of age and over take one 60mg tablet with water every 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
Storage and handling
store between 20° and 25°C (68° and 77°F) protect from excessive moisture each tablet contains: sodium 2.7mg(for 60 mg), sodium 8.2mg(for 180 mg) this product meets the requirements of USP Dissolution Test 2 Tamper Evident: Do not use if imprinted inner safety seal is torn or missing
Contacts and useful links#
Label contents#
Full prescribing information#
HIVES Active ingredient (in each film-coated tablet)
Fexofenadine HCl USP 60 mg
Fexofenadine HCl USP 180 mg
Purpose
Antihistamine
INDICATIONS & USAGE SECTION
Uses
reduces hives and relieves itching due to hives (urticaria). This product will not prevent hives or an allergic skin reaction from occurring.
Warnings
OTC - WHEN USING SECTION
Severe Allergy Warning:Get emergency help immediatelyif 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 profession 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
to preventhives 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
- 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
- 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
- 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 (for 60mg)
adults and children 12 years of age and over | take one 60mg tablet with water every 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 |
Directions (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 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
- store between 20° and 25°C (68° and 77°F)
- protect from excessive moisture
- each tablet contains:sodium 2.7mg(for 60 mg), sodium 8.2mg(for 180 mg)
- this product meets the requirements of USP Dissolution Test 2
- Tamper Evident:Do not use if imprinted inner safety seal is torn or missing
Inactive ingredients
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?
Call toll-free 1-855-724-3436
Manufactured by:
ScieGen Pharmaceuticals, Inc.
Hauppauge, NY 11788 USA
ALLERGY Active ingredient (in each film-coated tablet)
Fexofenadine HCl USP 60 mg
Fexofenadine HCl USP 180 mg
Purpose
Antihistamine
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
Warnings
Do not use
if you have ever had an allergic reaction to this product or any of its ingredients.
Ask a doctor before use if you have
kidney disease. Your doctor should determine if you need a different dose.
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)
Stop use and ask a doctor if
an allergic reaction to this product occurs. Seek medical help right away.
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 (for 60mg)
adults and children 12 years of age and over | take one 60mg tablet with water every 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 |
Directions (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 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
- store between 20° and 25°C (68° and 77°F)
- protect from excessive moisture
- each tablet contains:sodium 2.7mg(for 60 mg), sodium 8.2mg(for 180 mg)
- this product meets the requirements of USP Dissolution Test 2
- Tamper Evident:Do not use if imprinted inner safety seal is torn or missing
Inactive ingredients
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?
Call toll-free 1-855-724-3436
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
Manufactured by:
ScieGen Pharmaceuticals, Inc.
Hauppauge, NY 11788 USA
Package/Label Principal Display Panel
Fexofenadine Hydrochloride Tablets USP 60mg
Package/Label Principal Display Panel
Fexofenadine Hydrochloride Tablets USP 60mg
Package/Label Principal Display Panel
Fexofenadine Hydrochloride Tablets USP 180mg
Package/Label Principal Display Panel
Fexofenadine Hydrochloride Tablets USP 180mg
Package/Label Principal Display Panel
Fexofenadine Hydrochloride Tablets USP 60mg
Package/Label Principal Display Panel
Fexofenadine Hydrochloride Tablets USP 60mg
Package/Label Principal Display Panel
Fexofenadine Hydrochloride Tablets USP 180mg
Package/Label Principal Display Panel
Fexofenadine Hydrochloride Tablets USP 180mg
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | SPL version |
|---|---|---|---|
| 997420 | fexofenadine HCl 180 MG 24 HR Oral Tablet | PSN | 8 |
| 997501 | fexofenadine HCl 60 MG Oral Tablet | PSN | 8 |
| 997420 | fexofenadine hydrochloride 180 MG Oral Tablet | SCD | 8 |
| 997501 | fexofenadine hydrochloride 60 MG Oral Tablet | SCD | 8 |
| 997420 | fexofenadine HCl 180 MG 24 HR Oral Tablet | SY | 8 |
DailyMed Pharmacologic Classes#
| Class | Version | Type | Effective |
|---|---|---|---|
| FEXOFENADINE Pharmacologic Class Indexing | 3 | Indexing - Pharmacologic Class | 20180813 |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| b893258d-0942-3d8a-3411-056ea0788ff5 | Product name | 1 | 20140508 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 50228-201-01 | fexofenadine hcl | 30 in 1 BOTTLE | TABLET, FILM COATED | 30 | 8 | |
| 50228-201-02 | fexofenadine hcl | 1000 in 1 BOTTLE | TABLET, FILM COATED | 1000 | 8 | |
| 50228-201-03 | fexofenadine hcl | 30 in 1 BOTTLE | TABLET, FILM COATED | 30 | 8 | |
| 50228-201-04 | fexofenadine hcl | 1000 in 1 BOTTLE | TABLET, FILM COATED | 1000 | 8 | |
| 50228-202-01 | fexofenadine hcl | 30 in 1 BOTTLE | TABLET, FILM COATED | 30 | 8 | |
| 50228-202-02 | fexofenadine hcl | 1000 in 1 BOTTLE | TABLET, FILM COATED | 1000 | 8 | |
| 50228-202-03 | fexofenadine hcl | 30 in 1 BOTTLE | TABLET, FILM COATED | 30 | 8 | |
| 50228-202-04 | fexofenadine hcl | 1000 in 1 BOTTLE | TABLET, FILM COATED | 1000 | 8 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 50228-201 | FEXOFENADINE HCL TABLET, FILM COATED [SCIEGEN PHARMACEUTICALS, INC.] | 8 | Current NDC, Legacy NDC, 4 package rows | 20241226_b7e9477d-33d9-4463-b8a6-69af5f71ce35.zip |
| 50228-202 | FEXOFENADINE HCL TABLET, FILM COATED [SCIEGEN PHARMACEUTICALS, INC.] | 8 | Current NDC, Legacy NDC, 4 package rows | 20241226_b7e9477d-33d9-4463-b8a6-69af5f71ce35.zip |
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | SPL version | Uploaded |
|---|---|---|---|---|
| FEXOFENADINE HYDROCHLORIDE | ACTIVE INGREDIENT | 2S068B75ZU | 3 | |
| FEXOFENADINE | ACTIVE MOIETY | E6582LOH6V | 3 | |
| ANHYDROUS LACTOSE | INACTIVE INGREDIENT | 3SY5LH9PMK | 3 | |
| COLLOIDAL SILICON DIOXIDE | INACTIVE INGREDIENT | ETJ7Z6XBU4 | 3 | |
| CROSCARMELLOSE SODIUM | INACTIVE INGREDIENT | M28OL1HH48 | 3 | |
| FERRIC OXIDE RED | INACTIVE INGREDIENT | 1K09F3G675 | 3 | |
| FERRIC OXIDE YELLOW | INACTIVE INGREDIENT | EX438O2MRT | 3 | |
| HYPROMELLOSES | INACTIVE INGREDIENT | 3NXW29V3WO | 3 | |
| LACTOSE MONOHYDRATE | INACTIVE INGREDIENT | EWQ57Q8I5X | 3 | |
| POLYETHYLENE GLYCOLS | INACTIVE INGREDIENT | 3WJQ0SDW1A | 3 | |
| STARCH, CORN | INACTIVE INGREDIENT | O8232NY3SJ | 3 | |
| STEARIC ACID | INACTIVE INGREDIENT | 4ELV7Z65AP | 3 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | 3 |
Products#
Every source-derived product name is available through these pages.
- fexofenadine hcl
- ANHYDROUS LACTOSE
- SILICON DIOXIDE
- STARCH, CORN
- CROSCARMELLOSE SODIUM
- LACTOSE MONOHYDRATE
- STEARIC ACID
- HYPROMELLOSE, UNSPECIFIED
- POLYETHYLENE GLYCOL, UNSPECIFIED
- FERRIC OXIDE RED
- TITANIUM DIOXIDE
- FERRIC OXIDE YELLOW
- FEXOFENADINE HYDROCHLORIDE
- FEXOFENADINE
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 50228-201 | 50228-201-01, 50228-201-02, 50228-201-03, 50228-201-04 |
| 50228-202 | 50228-202-01, 50228-202-02, 50228-202-03, 50228-202-04 |
Ingredients#
Every source-derived ingredient row is available through these pages.
Source Document#
Inactive ingredient matches#
Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.
| DailyMed ingredient | IID ingredient | UNII | Dosage form / route | Potency | Maximum daily exposure | Match |
|---|---|---|---|---|---|---|
| HYPROMELLOSES | HYPROMELLOSE | 3NXW29V3WO | TABLET, FILM COATED / ORAL | 582 mg | ||
| STEARIC ACID | STEARIC ACID | 4ELV7Z65AP | TABLET, FILM COATED / ORAL | 176 mg | ||
| HYPROMELLOSES | HYPROMELLOSE | 3NXW29V3WO | TABLET, FILM COATED / ORAL | 582 mg | ||
| FERRIC OXIDE RED | FERRIC OXIDE RED | 1K09F3G675 | TABLET, FILM COATED / ORAL | 3 mg | ||
| ANHYDROUS LACTOSE | ANHYDROUS LACTOSE | 3SY5LH9PMK | TABLET, FILM COATED / ORAL | 2906 mg | ||
| CROSCARMELLOSE SODIUM | CROSCARMELLOSE SODIUM | M28OL1HH48 | TABLET, FILM COATED / ORAL | 330 mg | ||
| STARCH, CORN | STARCH, CORN | O8232NY3SJ | TABLET, FILM COATED / ORAL | 2000 mg | ||
| FERRIC OXIDE YELLOW | FERRIC OXIDE YELLOW | EX438O2MRT | TABLET, FILM COATED / ORAL | 6 mg | ||
| COLLOIDAL SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | TABLET, FILM COATED / ORAL | 166 mg | ||
| STEARIC ACID | STEARIC ACID | 4ELV7Z65AP | TABLET, FILM COATED / ORAL | 176 mg | ||
| COLLOIDAL SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | TABLET, FILM COATED / ORAL | 166 mg | ||
| HYPROMELLOSES | HYPROMELLOSE | 3NXW29V3WO | TABLET, FILM COATED / ORAL | 582 mg | ||
| CROSCARMELLOSE SODIUM | CROSCARMELLOSE SODIUM | M28OL1HH48 | TABLET, FILM COATED / ORAL | 330 mg | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | TABLET, FILM COATED / ORAL | 36 mg | ||
| FERRIC OXIDE YELLOW | FERRIC OXIDE YELLOW | EX438O2MRT | TABLET, FILM COATED / ORAL | 6 mg | ||
| COLLOIDAL SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | TABLET, FILM COATED / ORAL | 166 mg | ||
| HYPROMELLOSES | HYPROMELLOSE | 3NXW29V3WO | TABLET, FILM COATED / ORAL | 582 mg | ||
| FERRIC OXIDE RED | FERRIC OXIDE RED | 1K09F3G675 | TABLET, FILM COATED / ORAL | 3 mg | ||
| ANHYDROUS LACTOSE | ANHYDROUS LACTOSE | 3SY5LH9PMK | TABLET, FILM COATED / ORAL | 2906 mg | ||
| STEARIC ACID | STEARIC ACID | 4ELV7Z65AP | TABLET, FILM COATED / ORAL | 176 mg | ||
| STARCH, CORN | STARCH, CORN | O8232NY3SJ | TABLET, FILM COATED / ORAL | 2000 mg | ||
| CROSCARMELLOSE SODIUM | CROSCARMELLOSE SODIUM | M28OL1HH48 | TABLET, FILM COATED / ORAL | 330 mg | ||
| HYPROMELLOSES | HYPROMELLOSE | 3NXW29V3WO | TABLET, FILM COATED / ORAL | 582 mg | ||
| COLLOIDAL SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | TABLET, FILM COATED / ORAL | 166 mg | ||
| LACTOSE MONOHYDRATE | LACTOSE MONOHYDRATE | EWQ57Q8I5X | TABLET, FILM COATED / ORAL | 968 mg | ||
| ANHYDROUS LACTOSE | ANHYDROUS LACTOSE | 3SY5LH9PMK | TABLET, FILM COATED / ORAL | 2906 mg | ||
| FERRIC OXIDE RED | FERRIC OXIDE RED | 1K09F3G675 | TABLET, FILM COATED / ORAL | 3 mg | ||
| ANHYDROUS LACTOSE | ANHYDROUS LACTOSE | 3SY5LH9PMK | TABLET, FILM COATED / ORAL | 2906 mg | ||
| LACTOSE MONOHYDRATE | LACTOSE MONOHYDRATE | EWQ57Q8I5X | TABLET, FILM COATED / ORAL | 968 mg | ||
| STEARIC ACID | STEARIC ACID | 4ELV7Z65AP | TABLET, FILM COATED / ORAL | 176 mg | ||
| STARCH, CORN | STARCH, CORN | O8232NY3SJ | TABLET, FILM COATED / ORAL | 2000 mg | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | TABLET, FILM COATED / ORAL | 36 mg | ||
| STARCH, CORN | STARCH, CORN | O8232NY3SJ | TABLET, FILM COATED / ORAL | 2000 mg | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | TABLET, FILM COATED / ORAL | 36 mg | ||
| STEARIC ACID | STEARIC ACID | 4ELV7Z65AP | TABLET, FILM COATED / ORAL | 176 mg | ||
| ANHYDROUS LACTOSE | ANHYDROUS LACTOSE | 3SY5LH9PMK | TABLET, FILM COATED / ORAL | 2906 mg | ||
| STARCH, CORN | STARCH, CORN | O8232NY3SJ | TABLET, FILM COATED / ORAL | 2000 mg | ||
| COLLOIDAL SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | TABLET, FILM COATED / ORAL | 166 mg | ||
| COLLOIDAL SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | TABLET, FILM COATED / ORAL | 166 mg | ||
| CROSCARMELLOSE SODIUM | CROSCARMELLOSE SODIUM | M28OL1HH48 | TABLET, FILM COATED / ORAL | 330 mg | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | TABLET, FILM COATED / ORAL | 36 mg | ||
| ANHYDROUS LACTOSE | ANHYDROUS LACTOSE | 3SY5LH9PMK | TABLET, FILM COATED / ORAL | 2906 mg | ||
| LACTOSE MONOHYDRATE | LACTOSE MONOHYDRATE | EWQ57Q8I5X | TABLET, FILM COATED / ORAL | 968 mg | ||
| STARCH, CORN | STARCH, CORN | O8232NY3SJ | TABLET, FILM COATED / ORAL | 2000 mg | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | TABLET, FILM COATED / ORAL | 36 mg | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | TABLET, FILM COATED / ORAL | 36 mg | ||
| COLLOIDAL SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | TABLET, FILM COATED / ORAL | 166 mg | ||
| FERRIC OXIDE RED | FERRIC OXIDE RED | 1K09F3G675 | TABLET, FILM COATED / ORAL | 3 mg | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | TABLET, FILM COATED / ORAL | 36 mg | ||
| STEARIC ACID | STEARIC ACID | 4ELV7Z65AP | TABLET, FILM COATED / ORAL | 176 mg | ||
| COLLOIDAL SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | TABLET, FILM COATED / ORAL | 166 mg | ||
| CROSCARMELLOSE SODIUM | CROSCARMELLOSE SODIUM | M28OL1HH48 | TABLET, FILM COATED / ORAL | 330 mg | ||
| LACTOSE MONOHYDRATE | LACTOSE MONOHYDRATE | EWQ57Q8I5X | TABLET, FILM COATED / ORAL | 968 mg | ||
| ANHYDROUS LACTOSE | ANHYDROUS LACTOSE | 3SY5LH9PMK | TABLET, FILM COATED / ORAL | 2906 mg | ||
| STEARIC ACID | STEARIC ACID | 4ELV7Z65AP | TABLET, FILM COATED / ORAL | 176 mg | ||
| FERRIC OXIDE YELLOW | FERRIC OXIDE YELLOW | EX438O2MRT | TABLET, FILM COATED / ORAL | 6 mg | ||
| FERRIC OXIDE RED | FERRIC OXIDE RED | 1K09F3G675 | TABLET, FILM COATED / ORAL | 3 mg | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | TABLET, FILM COATED / ORAL | 36 mg | ||
| STARCH, CORN | STARCH, CORN | O8232NY3SJ | TABLET, FILM COATED / ORAL | 2000 mg | ||
| ANHYDROUS LACTOSE | ANHYDROUS LACTOSE | 3SY5LH9PMK | TABLET, FILM COATED / ORAL | 2906 mg |
Orange Book application contexts#
All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A204507-002 | FEXOFENADINE HYDROCHLORIDE ALLERGY | FEXOFENADINE HYDROCHLORIDE | 60MG | TABLET / ORAL | 2015-09-16 | ||
| A204507-003 | FEXOFENADINE HYDROCHLORIDE ALLERGY | FEXOFENADINE HYDROCHLORIDE | 180MG | TABLET / ORAL | 2015-09-16 | ||
| A204507-004 | FEXOFENADINE HYDROCHLORIDE HIVES | FEXOFENADINE HYDROCHLORIDE | 60MG | TABLET / ORAL | 2015-09-16 | ||
| A204507-005 | FEXOFENADINE HYDROCHLORIDE HIVES | FEXOFENADINE HYDROCHLORIDE | 180MG | TABLET / ORAL | 2015-09-16 |
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.
| Captured | Edition | Application-product | Trade name | Strength | Dosage form / route | Product TE source text | RLD / RS | Approval date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-10-15 13:18:30 | 2026-09 | A204507-002 | FEXOFENADINE HYDROCHLORIDE ALLERGY | 60MG | TABLET / ORAL | 2015-09-16 | c2088c7a36db… | ||
| 2026-10-15 13:18:30 | 2026-09 | A204507-003 | FEXOFENADINE HYDROCHLORIDE ALLERGY | 180MG | TABLET / ORAL | 2015-09-16 | c2088c7a36db… | ||
| 2026-10-15 13:18:30 | 2026-09 | A204507-004 | FEXOFENADINE HYDROCHLORIDE HIVES | 60MG | TABLET / ORAL | 2015-09-16 | c2088c7a36db… | ||
| 2026-10-15 13:18:30 | 2026-09 | A204507-005 | FEXOFENADINE HYDROCHLORIDE HIVES | 180MG | TABLET / ORAL | 2015-09-16 | c2088c7a36db… | ||
| 2026-09-14 22:38:34 | 2026-08 | A204507-002 | FEXOFENADINE HYDROCHLORIDE ALLERGY | 60MG | TABLET / ORAL | 2015-09-16 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | A204507-003 | FEXOFENADINE HYDROCHLORIDE ALLERGY | 180MG | TABLET / ORAL | 2015-09-16 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | A204507-004 | FEXOFENADINE HYDROCHLORIDE HIVES | 60MG | TABLET / ORAL | 2015-09-16 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | A204507-005 | FEXOFENADINE HYDROCHLORIDE HIVES | 180MG | TABLET / ORAL | 2015-09-16 | 84e616aacf4f… | ||
| 2026-08-18 06:07:40 | 2026-07 | A204507-002 | FEXOFENADINE HYDROCHLORIDE ALLERGY | 60MG | TABLET / ORAL | 2015-09-16 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A204507-003 | FEXOFENADINE HYDROCHLORIDE ALLERGY | 180MG | TABLET / ORAL | 2015-09-16 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A204507-004 | FEXOFENADINE HYDROCHLORIDE HIVES | 60MG | TABLET / ORAL | 2015-09-16 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A204507-005 | FEXOFENADINE HYDROCHLORIDE HIVES | 180MG | TABLET / ORAL | 2015-09-16 | caaa826d4ba7… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A204507-002 | FEXOFENADINE HYDROCHLORIDE ALLERGY | 60MG | TABLET / ORAL | 2015-09-16 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A204507-003 | FEXOFENADINE HYDROCHLORIDE ALLERGY | 180MG | TABLET / ORAL | 2015-09-16 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A204507-004 | FEXOFENADINE HYDROCHLORIDE HIVES | 60MG | TABLET / ORAL | 2015-09-16 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A204507-005 | FEXOFENADINE HYDROCHLORIDE HIVES | 180MG | TABLET / ORAL | 2015-09-16 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A204507-002 | FEXOFENADINE HYDROCHLORIDE ALLERGY | 60MG | TABLET / ORAL | 2015-09-16 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A204507-003 | FEXOFENADINE HYDROCHLORIDE ALLERGY | 180MG | TABLET / ORAL | 2015-09-16 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A204507-004 | FEXOFENADINE HYDROCHLORIDE HIVES | 60MG | TABLET / ORAL | 2015-09-16 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A204507-005 | FEXOFENADINE HYDROCHLORIDE HIVES | 180MG | TABLET / ORAL | 2015-09-16 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A204507-002 | FEXOFENADINE HYDROCHLORIDE ALLERGY | 60MG | TABLET / ORAL | 2015-09-16 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A204507-003 | FEXOFENADINE HYDROCHLORIDE ALLERGY | 180MG | TABLET / ORAL | 2015-09-16 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A204507-004 | FEXOFENADINE HYDROCHLORIDE HIVES | 60MG | TABLET / ORAL | 2015-09-16 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A204507-005 | FEXOFENADINE HYDROCHLORIDE HIVES | 180MG | TABLET / ORAL | 2015-09-16 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A204507-002 | FEXOFENADINE HYDROCHLORIDE ALLERGY | 60MG | TABLET / ORAL | 2015-09-16 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A204507-003 | FEXOFENADINE HYDROCHLORIDE ALLERGY | 180MG | TABLET / ORAL | 2015-09-16 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A204507-004 | FEXOFENADINE HYDROCHLORIDE HIVES | 60MG | TABLET / ORAL | 2015-09-16 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A204507-005 | FEXOFENADINE HYDROCHLORIDE HIVES | 180MG | TABLET / ORAL | 2015-09-16 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A204507-002 | FEXOFENADINE HYDROCHLORIDE ALLERGY | 60MG | TABLET / ORAL | 2015-09-16 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A204507-003 | FEXOFENADINE HYDROCHLORIDE ALLERGY | 180MG | TABLET / ORAL | 2015-09-16 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A204507-004 | FEXOFENADINE HYDROCHLORIDE HIVES | 60MG | TABLET / ORAL | 2015-09-16 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A204507-005 | FEXOFENADINE HYDROCHLORIDE HIVES | 180MG | TABLET / ORAL | 2015-09-16 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A204507-002 | FEXOFENADINE HYDROCHLORIDE ALLERGY | 60MG | TABLET / ORAL | 2015-09-16 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A204507-003 | FEXOFENADINE HYDROCHLORIDE ALLERGY | 180MG | TABLET / ORAL | 2015-09-16 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A204507-004 | FEXOFENADINE HYDROCHLORIDE HIVES | 60MG | TABLET / ORAL | 2015-09-16 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A204507-005 | FEXOFENADINE HYDROCHLORIDE HIVES | 180MG | TABLET / ORAL | 2015-09-16 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A204507-002 | FEXOFENADINE HYDROCHLORIDE ALLERGY | 60MG | TABLET / ORAL | 2015-09-16 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A204507-003 | FEXOFENADINE HYDROCHLORIDE ALLERGY | 180MG | TABLET / ORAL | 2015-09-16 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A204507-004 | FEXOFENADINE HYDROCHLORIDE HIVES | 60MG | TABLET / ORAL | 2015-09-16 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A204507-005 | FEXOFENADINE HYDROCHLORIDE HIVES | 180MG | TABLET / ORAL | 2015-09-16 | 2680178bc6a6… |
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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| fexofenadine hcl | FEXOFENADINE HCL | ScieGen Pharmaceuticals, Inc. | b7e9477d-33d9-4463-b8a6-69af5f71ce35 | 2024-12-24 | Warnings | 50228-202-04 50228-202-03 50228-202-01 50228-201-01 50228-202-02 50228-201-04 50228-201-02 50228-201-03 50228-202 50228-201 50228020101 50228020204 50228020202 50228020103 50228020201 50228020203 50228020104 50228020102 2a0b48b8-5955-9ab7-e063-6394a90a6b24 b7e9477d-33d9-4463-b8a6-69af5f71ce35 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.