Fexofenadine Hydrochloride
Tablet · Oral
Active ingredient
Drug Facts Active ingredient (in each 5 mL) Fexofenadine Hydrochloride USP 30 mg
Purpose
Purpose Antihistamine
Uses
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
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
Ask a doctor before use if you have kidney disease. Your doctor should determine if you need a different dose.
When using this product
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
Stop use and ask a doctor if an allergic reaction to this product occurs. Seek medical help right away.
Pregnancy or breast-feeding
If pregnant or breast-feeding, ask a health professional before use.
Keep out of reach of children
Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.
Directions
Directions shake well before using use only with enclosed dosing cup adults and children 12 years of age and over take 10 mL every 12 hours; do not take more than 20 mL in 24 hours children 2 to under 12 years of age take 5 mL every 12 hours; do not take more than 10 mL in 24 hours children under 2 years of age ask a doctor adults 65 years of age and older ask a doctor consumers with kidney disease ask a doctor Note: mL = milliliters
Other information
Other information each 5 mL contains: phosphorus 15 mg and sodium 18 mg safety sealed: do not use if carton is opened or seal under cap opening is broken or missing store between 20° to 25°C (68° to 77°F)
Inactive ingredients
Inactive ingredients dibasic sodium phosphate anhydrous, edetate disodium, ethylparaben, methylparaben, monobasic sodium phosphate, poloxamer 407, propylene glycol, purified water, raspberry flavor (contains propylene glycol and triacetin), raspberry sweet flavor (contains propylene glycol), sucrose, titanium dioxide, xanthan gum, xylitol. Questions or comments? call 1-855-274-4122 (Monday – Friday 8:30 AM to 5:00 PM EST) Distributed by: AUROHEALTH LLC 279 Princeton-Hightstown Road East Windsor, NJ 08520 Made in India Code: AP/DRUGS/04/2016
Label text from the FDA structured product label by Aurohealth LLC (revised Sep 1, 2026). Long sections are shortened; the complete label is on DailyMed.
Active ingredients
- Fexofenadine Hydrochloride in 45 products
Fexofenadine Hydrochloride NDC products (45)
| NDC | Strength & form | Labeler | Type |
|---|---|---|---|
| 10202-229 | Fexofenadine Hydrochloride 180 mg/1 Tablet, Film Coated | 7-eleven | ANDA |
| 46122-779 | Fexofenadine Hydrochloride 180 mg/1 Tablet, Film Coated | AMERISOURCE BERGEN | ANDA |
| 73629-008 | Fexofenadine Hydrochloride 180 mg/1 Tablet, Film Coated | AMZ789 LLC | ANDA |
| 58602-878 | Fexofenadine Hydrochloride 180 mg/1 Tablet, Film Coated | Aurohealth LLC | ANDA |
| 58602-877 | Fexofenadine Hydrochloride 60 mg/1 Tablet, Film Coated | Aurohealth LLC | ANDA |
| 58602-876 | Fexofenadine Hydrochloride 30 mg/1 Tablet, Film Coated | Aurohealth LLC | ANDA |
| 58602-427 | Fexofenadine Hydrochloride 30 mg/5mL Suspension | Aurohealth LLC | ANDA |
| 58602-426 | Fexofenadine Hydrochloride 30 mg/5mL Suspension | Aurohealth LLC | ANDA |
| 68001-439 | Fexofenadine Hydrochloride 60 mg/1 Tablet | BluePoint Laboratories | ANDA |
| 68001-440 | Fexofenadine Hydrochloride 180 mg/1 Tablet | BluePoint Laboratories | ANDA |
| 68016-995 | Fexofenadine Hydrochloride 180 mg/1 Tablet | Chain Drug Consortium, LLC | ANDA |
| 63868-025 | Fexofenadine Hydrochloride 180 mg/1 Tablet | Chain Drug Marketing Associate | ANDA |
| 69842-052 | Fexofenadine Hydrochloride 180 mg/1 Tablet | CVS Health Corp. | ANDA |
| 51316-800 | Fexofenadine Hydrochloride 180 mg/1 Tablet | CVS PHARMACY, INC | ANDA |
| 55910-111 | Fexofenadine Hydrochloride 180 mg/1 Tablet | Dollar General | ANDA |
| 43598-936 | Fexofenadine Hydrochloride 60 mg/1 Tablet | Dr. Reddy's Laboratories Inc. | ANDA |
| 43598-809 | Fexofenadine Hydrochloride 180 mg/1 Tablet | Dr. Reddy's Laboratories Inc. | ANDA |
| 55111-782 | Fexofenadine Hydrochloride 30 mg/1 Tablet | Dr. Reddy's Laboratories Limited | ANDA |
| 55111-783 | Fexofenadine Hydrochloride 60 mg/1 Tablet | Dr. Reddy's Laboratories Limited | ANDA |
| 55111-784 | Fexofenadine Hydrochloride 180 mg/1 Tablet | Dr. Reddy's Laboratories Limited | ANDA |
| 62207-623 | Fexofenadine Hydrochloride 180 mg/1 Tablet | Granules India Limited | ANDA |
| 62207-889 | Fexofenadine Hydrochloride 60 mg/1 Tablet, Film Coated | Granules India Limited | ANDA |
| 62207-891 | Fexofenadine Hydrochloride 180 mg/1 Tablet, Film Coated | Granules India Limited | ANDA |
| 62207-765 | Fexofenadine Hydrochloride 60 mg/1 Tablet | Granules India Ltd | ANDA |
| 62207-766 | Fexofenadine Hydrochloride 180 mg/1 Tablet | Granules India Ltd | ANDA |
| 30142-878 | Fexofenadine Hydrochloride 180 mg/1 Tablet | KROGER COMPANY | ANDA |
| 0904-7050 | Fexofenadine Hydrochloride 180 mg/1 Tablet | Major Pharmaceuticals | ANDA |
| 0615-8648 | Fexofenadine Hydrochloride 180 mg/1 Tablet, Film Coated | NCS HealthCare of KY, LLC dba Vangard Labs | ANDA |
| 51655-231 | Fexofenadine Hydrochloride 180 mg/1 Tablet | Northwind Health Company, LLC | ANDA |
| 84324-045 | Fexofenadine Hydrochloride 60 mg/1 Tablet | NUVICARE LLC | ANDA |
| 84324-008 | Fexofenadine Hydrochloride 180 mg/1 Tablet | NUVICARE LLC | ANDA |
| 51660-998 | Fexofenadine Hydrochloride 180 mg/1 Tablet, Film Coated | OHM LABORATORIES INC. | ANDA |
| 45802-847 | Fexofenadine Hydrochloride 180 mg/1 Tablet, Film Coated | Padagis Israel Pharmaceuticals Ltd | ANDA |
| 72090-010 | Fexofenadine Hydrochloride 180 mg/1 Tablet | Pioneer Life Sciences, LLC | ANDA |
| 71205-739 | Fexofenadine Hydrochloride 180 mg/1 Tablet, Film Coated | Proficient Rx LP | ANDA |
| 71309-091 | Fexofenadine Hydrochloride 180 mg/1 Tablet | Safrel Pharmaceuticals, LLC. | ANDA |
| 68196-107 | Fexofenadine Hydrochloride 180 mg/1 Tablet | Sam's West Inc. | ANDA |
| 68210-2210 | Fexofenadine Hydrochloride 180 mg/1 Tablet, Film Coated | SPIRIT PHARMACEUTICALS LLC | ANDA |
| 68210-4090 | Fexofenadine Hydrochloride 180 mg/1 Tablet, Film Coated | SPIRIT PHARMACEUTICALS LLC | ANDA |
| 70677-1009 | Fexofenadine Hydrochloride 180 mg/1 Tablet | Strategic Sourcing Services, LLC | ANDA |
| 0363-0783 | Fexofenadine Hydrochloride 60 mg/1 Tablet | Walgreens Company | ANDA |
| 73581-025 | Fexofenadine Hydrochloride 60 mg/1 Tablet | YYBA Corp | ANDA |
| 73581-026 | Fexofenadine Hydrochloride 180 mg/1 Tablet | YYBA Corp | ANDA |
| 73581-027 | Fexofenadine Hydrochloride 180 mg/1 Tablet | YYBA Corp | ANDA |
| 82725-0102 | Fexofenadine Hydrochloride 180 mg/1 Tablet | Cabinet Health P.B.C. | DRUG FOR FURTHER PROCESSING |
Fexofenadine Hydrochloride recalls
- D-0273-2024 Jan 31, 2024 · Class II · Completed
CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufacturing equipment. - D-0907-2023 Jul 19, 2023 · Class II · Terminated
Failed Impurities/Degradation Specifications
Frequently asked questions
What is Fexofenadine Hydrochloride used for?
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
Who makes Fexofenadine Hydrochloride?
Fexofenadine Hydrochloride is listed by 30 labelers in the FDA NDC directory, including 7-eleven, AMERISOURCE BERGEN, AMZ789 LLC, Aurohealth LLC.
Has Fexofenadine Hydrochloride been recalled?
The FDA enforcement database lists 2 recalls for Fexofenadine Hydrochloride, most recently D-0273-2024 (class ii): CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufacturing equipment.