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
FEXOFENADINE HYDROCHLORIDE TABLETS USP, 60mg and 180 mg Allergy
- Manufacturer
- Safrel Pharmaceuticals, LLC.
- Effective date
- 2023-07-31
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 1
- Source
- full-release
- Hydrated at
- 2026-05-31 23:55:46
Label at a glance#
ProductFexofenadine HCl
Active ingredientFEXOFENADINE HYDROCHLORIDE
Label structure9 sections
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
Contacts and useful links#
Label contents#
Full prescribing information#
ALLERGYActive ingredient (in each film-coated tablet)
Fexofenadine HCl USP, 60mg
Purpose
Antihistamine
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
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.
If pregnant or breast-feeding,
ask a health professional before use.
Keep out of reach of children.
In case of overdose, get medical help or contact a Poison Control Center right away (1800-222-1222).
Directions
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
Other information
- 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
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?
Fexofenadine 60 mg
DailyMed RxNorm Mappings#
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 |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 71309-090-10 | 2026-01-29 | C162847 | 48780-1 | 49896155-afdc-586f-e063-e6dba90add90 | FEXOFENADINE HYDROCHLORIDE TABLETS USP, 60mg and 180 mg Allergy |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 71309-090-10 | Fexofenadine HCl | 100 in 1 BOTTLE | TABLET, FILM COATED | 100 | 1 |
DailyMed Dashboard NDC Coverage#
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 |
|---|---|
| 71309-090 | 71309-090-10 |
Ingredients#
Every source-derived ingredient row is available through these pages.
Source Document#
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 |
|---|---|---|---|---|---|---|
| 01c94d0a-30a6-baf4-e063-6394a90a90e3 | 01c94471-3509-4240-e063-6294a90a203b | 2023-07-31 | Warnings | 01c94d0a-30a6-baf4-e063-6394a90a90e3 01c94471-3509-4240-e063-6294a90a203b |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.