Fexofenadine Hydrochloride 30 mg/5mL
Fexofenadine Hydrochloride Oral · SUSPENSION · Aurohealth LLC
Fexofenadine hydrochloride is an antihistamine used to relieve allergy symptoms such as sneezing, itching, watery eyes, and runny nose. This over-the-counter suspension is taken by mouth and is available in a 30 mg/5mL strength.
Key Facts
- Brand Name
- Fexofenadine Hydrochloride
- Generic Name
- Fexofenadine Hydrochloride Oral
- NDC Code (Product)
58602-426- Manufacturer
- Aurohealth LLC
- Strength
- 30 mg/5mL
- Dosage Form
- SUSPENSION
- Route
- ORAL
- Marketing Status
- Application #
- ANDA213466
- Marketing Start
- 05/23/2023
Recall History
Perrigo Company PLC
Failed Impurities/Degradation Specifications; Out of specification result obtained for impurity A during stability testing.
Perrigo Company PLC
Failed Impurities/Degradation Specifications; Out of specification result obtained for impurity A during stability testing.
L. Perrigo Company
Failed Impurities/Degradation Specifications
L. Perrigo Company
Failed Impurities/Degradation Specifications
Aurolife Pharma, LLC
Failed Impurities/Degradation Specifications
Aurolife Pharma, LLC
Failed Impurities/Degradation Specifications
Perrigo Company PLC
Failed Impurities/Degradation Specifications; Out of specification result obtained for impurity A during stability testing.
Perrigo Company PLC
Failed Impurities/Degradation Specifications; Out of specification result obtained for impurity A during stability testing.
Perrigo Company PLC
Failed Impurities/Degradation Specifications; Out of specification result obtained for impurity A during stability testing.
Aurolife Pharma, LLC
Failed Impurities/Degradation Specifications
Side Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
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 temporarily relieves nasal congestion due to the common cold, hay fever or other upper respiratory allergies reduces swelling of nasal passages temporarily relieves sinus congestion and pressure temporarily restores freer breathing through the nose
Dosage & Administration
Directions do not divide, crush, chew or dissolve the tablet; swallow tablet whole adults and children 12 years of age and over take 1 tablet with a glass of water every 12 hours on an empty stomach; 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
Warnings
Warnings
Frequently Asked Questions
What is Fexofenadine Hydrochloride used for?
Fexofenadine hydrochloride is an antihistamine used to relieve allergy symptoms such as sneezing, itching, watery eyes, and runny nose. This over-the-counter suspension is taken by mouth and is available in a 30 mg/5mL strength.
Is Fexofenadine Hydrochloride a controlled substance?
Fexofenadine Hydrochloride is not classified as a controlled substance by the DEA.
What is the generic name for Fexofenadine Hydrochloride?
The generic name for Fexofenadine Hydrochloride is Fexofenadine Hydrochloride Oral. There are no other listed brand versions of Fexofenadine Hydrochloride Oral.
What is the NDC code for Fexofenadine Hydrochloride 30 mg/5mL?
The NDC (National Drug Code) for Fexofenadine Hydrochloride 30 mg/5mL is 58602-426, listed by Aurohealth LLC.
Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.
Data from openFDA · Public domain (CC0 1.0)