Fexofenadine hydrochloride

Label at a glance#

Contacts and useful links#

Label contents#

Full prescribing information#

Active ingredient(in each tablet)

OTC - ACTIVE INGREDIENT SECTION

Fexofenadine HCl USP, 180 mg

Purpose

OTC - PURPOSE SECTION

Antihistamine

Uses

INDICATIONS & USAGE SECTION

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

Do not use

OTC - DO NOT USE SECTION

if you have ever had an allergic reaction to this product or any of its ingredients

Ask a doctor before use if you have

OTC - ASK DOCTOR SECTION

kidney disease. Your doctor should determine if you need a different dose.

When using this product

OTC - WHEN USING SECTION

• do not take more than directed
• do not take at the same time as aluminium or magnesium antacids
• do not take with fruit juices (see directions)

Stop use and ask doctor if

OTC - STOP USE SECTION

an allergic reaction to this product occurs. Seek medical help right away.

If pregnant or breast-feeding

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a health professional before use.

Keep out of reach of children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Directions

DOSAGE & ADMINISTRATION SECTION

adults and children 12 years of age and over	1 tablet with water 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 information

SPL UNCLASSIFIED SECTION

• store between 20°and 25°C (68°and 77°F)
• protect from excessive moisture and light

Inactive ingredients

INACTIVE INGREDIENT SECTION

anhydrous lactose, colloidal silicon dioxide, corn starch,croscarmellose sodium, hypromellose, lactose monohydrate, polyethylene glycol 400, pregelatinized corn starch, red iron oxide, steric acid, titanium dioxide, and yellow iron oxide,

Questions or comments?

SPL UNCLASSIFIED SECTION

 call toll-free 1-800-935-6737

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

*Compare to 24 Hour Allegra® Allergy active ingredient
 

Fexofenadine Hydrochloride Tablets USP, 180 mg/antihistamine
 
Allergy Relief
Non-Drowsy 24 hour Allergy

Relief of:  Sneezing , Runny nose
Itchy, Watery Eyes &
Itchy Nose or Throat

Original Prescription Strength


150 Tablets 180 mg each

DailyMed RxNorm Mappings#

DailyMed Pharmacologic Classes#

DailyMed Product Concepts#

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

DailyMed Dashboard NDC Coverage#

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 13 matching rows.

• Fexofenadine hydrochloride
• FEXOFENADINE
• ANHYDROUS LACTOSE
• SILICON DIOXIDE
• CROSCARMELLOSE SODIUM
• HYPROMELLOSES
• LACTOSE MONOHYDRATE
• STARCH, PREGELATINIZED CORN
• STEARIC ACID
• FERRIC OXIDE RED
• FERRIC OXIDE YELLOW
• POLYETHYLENE GLYCOL 400
• TITANIUM DIOXIDE

NDC Codes#

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 12 matching rows.

Source Document#

Source XML

Orange Book application contexts#

All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.

Orange Book application contexts page 1 of 1 · 1 matching rows.

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 4 · 129 observed states.

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.