Fexofenadine HCL
Fexofenadine Hydrochloride Tablets USP, 180 mg
353323b7-67ce-7ce6-e063-6394a90a77d4
HUMAN OTC DRUG LABEL
May 15, 2025
Walmart Inc.
DUNS: 051957769
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Fexofenadine HCL
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
Product Classification
Product Specifications
INGREDIENTS (14)
Drug Labeling Information
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
PRINCIPAL DISPLAY PANEL
Fexofenadine Hydrochloride Tablets, USP 180 mg 45ct CTN
Fexofenadine Hydrochloride Tablets, USP 180 mg 45ct LBL
Fexofenadine Hydrochloride Tablets, USP 180 mg 90ct LBL
Fexofenadine Hydrochloride Tablets, USP 180 mg 180ct CTN
Fexofenadine Hydrochloride Tablets, USP 180 mg 300ct LBL
INDICATIONS & USAGE SECTION
USE(S)
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
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 right away.
OTC - ACTIVE INGREDIENT SECTION
ACTIVE INGREDIENT(S), in each tablet
Fexofenadine hydrochloride USP, 180 mg
OTC - PURPOSE SECTION
PURPOSE
Antihistamine
WARNINGS SECTION
WARNINGS
OTC - DO NOT USE SECTION
DO NOT USE
if you have ever had an allergic reaction to this product or any of its ingredients.
OTC - ASK DOCTOR SECTION
ASK A DOCTOR BEFORE USE IF
you have kidney 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.
**If pregnant or breast-feeding,**ask a health professional before use.
DOSAGE & ADMINISTRATION SECTION
DIRECTIONS
60 mg
|
adults and children 12 years of age and over |
take one 60 mg tablet with water every 12 hours; 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 |
180 mg
|
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 |
SPL UNCLASSIFIED SECTION
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 INGREDIENT SECTION
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.
OTC - QUESTIONS SECTION
QUESTIONS OR COMMENTS
call toll-free weekdays 9 AM to 5 PM EST at1-888-588-1418