Search by Drug Name or NDC
NDC 71610-0070-30 fexofenadine hcl 180 mg/1 Details
fexofenadine hcl 180 mg/1
fexofenadine hcl is a ORAL TABLET, FILM COATED in the HUMAN OTC DRUG category. It is labeled and distributed by Aphena Pharma Solutions - Tennessee, LLC. The primary component is FEXOFENADINE HYDROCHLORIDE.
MedlinePlus Drug Summary
Fexofenadine is used to relieve the allergy symptoms of seasonal allergic rhinitis (''hay fever''), including runny nose; sneezing; red, itchy, or watery eyes; or itching of the nose, throat, or roof of the mouth in adults and children 2 years of age and older. It is also used to relieve symptoms of urticaria (hives; red, itchy raised areas of the skin), including itching and rash in adults and children 6 months of age and older. Fexofenadine is in a class of medications called antihistamines. It works by blocking the effects of histamine, a substance in the body that causes allergy symptoms.
Related Packages: 71610-0070-30Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Fexofenadine
Product Information
| NDC | 71610-0070 |
|---|---|
| Product ID | 71610-070_c95ab4c6-4665-4554-91fe-98aec928f628 |
| Associated GPIs | 41550024100350 |
| GCN Sequence Number | 033716 |
| GCN Sequence Number Description | fexofenadine HCl TABLET 180 MG ORAL |
| HIC3 | Z2Q |
| HIC3 Description | ANTIHISTAMINES - 2ND GENERATION |
| GCN | 46594 |
| HICL Sequence Number | 011595 |
| HICL Sequence Number Description | FEXOFENADINE HCL |
| Brand/Generic | Generic |
| Proprietary Name | fexofenadine hcl |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | fexofenadine hcl |
| Product Type | HUMAN OTC DRUG |
| Dosage Form | TABLET, FILM COATED |
| Route | ORAL |
| Active Ingredient Strength | 180 |
| Active Ingredient Units | mg/1 |
| Substance Name | FEXOFENADINE HYDROCHLORIDE |
| Labeler Name | Aphena Pharma Solutions - Tennessee, LLC |
| Pharmaceutical Class | Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC] |
| DEA Schedule | n/a |
| Marketing Category | ANDA |
| Application Number | ANDA204507 |
| Listing Certified Through | 2024-12-31 |
Package
Package Images
NDC 71610-0070-30 (71610007030)
| NDC Package Code | 71610-070-30 |
|---|---|
| Billing NDC | 71610007030 |
| Package | 30 TABLET, FILM COATED in 1 BOTTLE (71610-070-30) |
| Marketing Start Date | 2018-05-18 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |
Standard Product Labeling (SPL)/Prescribing Information SPL b7bcde69-6f97-4fd9-9137-bfc170a51f00 Details
HIVES Active ingredient (in each film-coated tablet)
SPL UNCLASSIFIED SECTION
Warnings
Severe Allergy Warning: Get emergency help immediately if 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 prevent hives 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)
Directions (for 60mg)
Directions (for 180mg)
Other information
Inactive ingredients
Questions or comments?
ALLERGY Active ingredient (in each film-coated tablet)
Uses
Warnings
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)
Directions (for 60mg)
Directions (for 180mg)
Other information
Inactive ingredients
Repackaging Information
Please reference the How Supplied section listed above for a description of individual tablets. This drug product has been received by Aphena Pharma - TN in a manufacturer or distributor packaged configuration and repackaged in full compliance with all applicable cGMP regulations. The package configurations available from Aphena are listed below:
| Count | 180 mg |
| 30 | 71610-070-30 |
Store between 20°-25°C (68°-77°F). See USP Controlled Room Temperature. Dispense in a tight light-resistant container as defined by USP. Keep this and all drugs out of the reach of children.
Repackaged by:
Cookeville, TN 38506
20180531JH
INGREDIENTS AND APPEARANCE
| FEXOFENADINE HCL
fexofenadine hcl tablet, film coated |
||||||||||||||||||||||||||
|
||||||||||||||||||||||||||
|
||||||||||||||||||||||||||
|
||||||||||||||||||||||||||
|
||||||||||||||||||||||||||
|
||||||||||||||||||||||||||
|
||||||||||||||||||||||||||
| Labeler - Aphena Pharma Solutions - Tennessee, LLC (128385585) |
| Establishment | |||
| Name | Address | ID/FEI | Business Operations |
|---|---|---|---|
| Aphena Pharma Solutions - Tennessee, LLC | 128385585 | REPACK(71610-070) | |