FEXOFENADINE HYDROCHLORIDE
Allergy Relief Fexofenadine Hydrochlroride Tablets 180 mg
ec55732c-a3db-4445-a06d-0f98b21ed134
HUMAN OTC DRUG LABEL
Jun 9, 2025
NUVICARE LLC
DUNS: 119257565
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
FEXOFENADINE HYDROCHLORIDE
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
Product Classification
Product Specifications
INGREDIENTS (12)
Drug Labeling Information
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
INDICATIONS & USAGE SECTION
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 SECTION
Warnings
OTC - DO NOT USE SECTION
Do not useif you have ever had an allergic reaction to this product or any of its ingredients.
SPL UNCLASSIFIED SECTION
Drug Facts
OTC - ACTIVE INGREDIENT SECTION
Active ingredient (in each tablet)
Fexofenadine HCl 180 mg
OTC - PURPOSE SECTION
Purpose
Antihistamine
OTC - ASK DOCTOR SECTION
Ask a****doctor before use if you havekidney disease. Your doctor should determine if you need a different dose.
OTC - WHEN USING SECTION
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)**
OTC - STOP USE SECTION
Stop use and ask a doctor if an allergic reaction to this product occurs. Seek medical help right away.
OTC - PREGNANCY OR BREAST FEEDING SECTION
If pregnant or breast-feeding, ask a health professional before use.
OTC - KEEP OUT OF REACH OF CHILDREN SECTION
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.
DOSAGE & ADMINISTRATION SECTION
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 SAFETY INFORMATION
Other information store between 20º and 25ºC (68º and 77ºF) protect from excessive moisture
INACTIVE INGREDIENT SECTION
**Inactive ingredients:**colloidal silicone dioxide, croscarmellose sodium, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol/macrogol, povidone, pregelatinized starch, red iron oxide, silica, titanium dioxide, yellow iron oxide.
OTC - QUESTIONS SECTION
Call 1(718) 337-8733 or visit: support@nuvicare.com