Active Ingredients And Purpose
ACTIVE INGREDIENT(S) in each tablet
Fexofenadine hydrochloride USP, 180 mg
PURPOSE
Antihistamine
Fexofenadine Hydrochloride Tablets USP, 180 mg
- Manufacturer
- Strategic Sourcing Services | Hetero Labs Limited Unit V
- Effective date
- 2025-03-24
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 1
- Source
- full-release
- Hydrated at
- 2026-06-01 01:00:06
Key Label Information#
Uses
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
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.
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.
Directions And Dosage
DIRECTIONS
adults and children 12 years of age and over take one 180 mg 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 Label Information
INACTIVE INGREDIENTS
colloidal silicon dioxide, hypromellose, light liquid paraffin, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, pregelatinized starch, red iron oxide, sodium starch glycolate, talc, titanium dioxide and yellow iron oxide.
QUESTIONS OR COMMENTS
Call 833-358-6431 Monday to Friday 9:00 am to 7:00 pm EST
PRINCIPAL DISPLAY PANEL
Fexofenadine Hydrochloride Tablets, USP 180 mg 30s Container Label Fexofenadine Hydrochloride Tablets, USP 180 mg 30s Carton Label Fexofenadine Hydrochloride Tablets, USP 180 mg 500s Container Label Fexofenadine Hydrochloride Tablets, USP 180 mg 500s Carton Label
Label Images#
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 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 70677-1256-1 | Fexofenadine HCL | 1 in 1 CARTON | TABLET | 1 | 1 | |
| 70677-1256-1 | Fexofenadine HCL | 30 in 1 BOTTLE | TABLET | 30 | 1 | |
| 70677-1256-2 | Fexofenadine HCL | 1 in 1 CARTON | TABLET | 1 | 1 | |
| 70677-1256-2 | Fexofenadine HCL | 500 in 1 BOTTLE | TABLET | 500 | 1 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 70677-1256 | FEXOFENADINE HCL (FEXOFENADINE HCL) TABLET [STRATEGIC SOURCING SERVICES] | 1 | Current NDC, 4 package rows | 20250501_722eda62-9204-400a-8db4-e4aba9cd443b.zip |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 70677-1256-1 | EA - Each | 70677-1256 | 214cf67b-4aaa-48c1-887b-a3b50de12a87 | 1 | 2025-05-14 |
| 70677-1256-2 | EA - Each | 70677-1256 | 8722da54-5828-48f9-bf79-d14ca66854b8 | 1 | 2025-05-14 |
Products#
- Fexofenadine HCL
- FEXOFENADINE
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 70677-1256 | 70677-1256-1, 70677-1256-2 |
Ingredients#
Complete SPL Sections#
ACTIVE INGREDIENT(S) in each tablet
Fexofenadine hydrochloride 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. 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 (1-800-222-1222).
DIRECTIONS
adults and children 12 years of age and over take one 180 mg 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
Safety Sealed: do not use if carton is opened or if printed foil inner seal on the bottle is torn or missing. store between 20° and 25°C (68° and 77°F) protect from excessive moisture
INACTIVE INGREDIENTS
colloidal silicon dioxide, hypromellose, light liquid paraffin, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, pregelatinized starch, red iron oxide, sodium starch glycolate, talc, titanium dioxide and yellow iron oxide.
QUESTIONS OR COMMENTS
Call 833-358-6431 Monday to Friday 9:00 am to 7:00 pm EST
PRINCIPAL DISPLAY PANEL
Fexofenadine Hydrochloride Tablets, USP 180 mg 30s Container Label Fexofenadine Hydrochloride Tablets, USP 180 mg 30s Carton Label Fexofenadine Hydrochloride Tablets, USP 180 mg 500s Container Label Fexofenadine Hydrochloride Tablets, USP 180 mg 500s Carton Label