Fexofenadine hydrochloride

Label at a glance#

Contacts and useful links#

Label contents#

Full prescribing information#

ACTIVE INGREDIENT(S)

OTC - ACTIVE INGREDIENT SECTION

Fexofenadine HCl USP, 180 mg

PURPOSE

OTC - PURPOSE SECTION

Antihistamine

USE(S)

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

WARNINGS

WARNINGS SECTION

Do not use if you have ever had an allergic reaction to this product or any of its ingredients.

ASK A DOCTOR BEFORE USE IF

OTC - ASK DOCTOR SECTION

you have 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 right away.

DIRECTIONS

DOSAGE & ADMINISTRATION SECTION

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 INFORMATION

SPL UNCLASSIFIED SECTION

• safety sealed: do not use if carton is opened or if individual blister units are torn or opened
• store between 20⁰ and 25⁰C (68⁰ and 77⁰F)
• 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, stearic acid, titanium dioxide, and yellow iron oxide

QUESTIONS OR COMMENTS?

SPL UNCLASSIFIED SECTION

call 1-888-287-1915

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 49035-995-62

Non-Drowsy
Original Prescription Strength

Fexofenadine HCl Tablets USP,
180 mg/Antihistamine

Allergy Relief

Indoor and Outdoor Allergies
Relief of:

• Sneezing
• Runny nose
• Itchy, watery eyes
• Itchy nose or throat                                                                    180 mg EACH  15 TABLETS

DailyMed RxNorm Mappings#

DailyMed Pharmacologic Classes#

DailyMed Product Concepts#

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

DailyMed Dashboard NDC Coverage#

DailyMed Billing Units#

DailyMed Socrata Ingredients#

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
• STARCH, CORN
• CROSCARMELLOSE SODIUM
• HYPROMELLOSES
• LACTOSE MONOHYDRATE
• POLYETHYLENE GLYCOL 400
• FERRIC OXIDE RED
• STEARIC ACID
• TITANIUM DIOXIDE
• FERRIC OXIDE YELLOW

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

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 6 · 322 matching rows.

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.