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 hydrochloride USP, 60 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

Warnings

WARNINGS SECTION

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 aluminum or magnesium antacids
• do not take with fruit juices (see Directions)

Stop use and ask a 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 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

Other information

SPL UNCLASSIFIED SECTION

• Tamper Evident: do not use if foil seal under cap is missing, open or broken
• store between 20° to 25°C (68° to 77°F)
• protect from excessive moisture
• Meets USP Dissolution Test 2

Inactive ingredients

INACTIVE INGREDIENT SECTION

Butylated hydroxyanisole, crospovidone, FD&C Blue No. 1 Aluminum Lake, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polydextrose, polyethylene glycol, polysorbate 80, povidone, sodium lauryl sulfate, titanium dioxide and triacetin.

Questions or comments?

OTC - QUESTIONS SECTION

Call 1-877-446-3679 (1-877-4-INFO-RX)

Manufactured by: Mylan Pharmaceuticals Inc., Morgantown, WV 26505 U.S.A.

PRINCIPAL DISPLAY PANEL - 60 mg

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 0378-0781-91

Non-Drowsy

Fexofenadine HCl
Tablets, USP

60 mg

Allergy

12 HR

Antihistamine
Indoor/Outdoor Allergy Relief

• Sneezing
• Runny Nose
• Itchy, Watery Eyes
• Itchy Nose or Throat

RM-AR0781D3     60 Tablets

Directions

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

PRINCIPAL DISPLAY PANEL - 180 mg

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 0378-0782-93

Non-Drowsy

Fexofenadine HCl
Tablets, USP

180 mg

Allergy

24 HR

Antihistamine
Indoor/Outdoor Allergy Relief

• Sneezing
• Runny Nose
• Itchy, Watery Eyes
• Itchy Nose or Throat

RM-AR0782H3     30 Tablets

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

DailyMed Billing Units#

DailyMed Socrata Ingredients#

Products#

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

DailyMed product names page 1 of 1 · 16 matching rows.

• Fexofenadine Hydrochloride
• fexofenadine
• BUTYLATED HYDROXYANISOLE
• CROSPOVIDONE
• FD&C BLUE NO. 1
• HYPROMELLOSE, UNSPECIFIED
• LACTOSE MONOHYDRATE
• MAGNESIUM STEARATE
• MICROCRYSTALLINE CELLULOSE
• POLYDEXTROSE
• POLYETHYLENE GLYCOL, UNSPECIFIED
• POLYSORBATE 80
• POVIDONE, UNSPECIFIED
• SODIUM LAURYL SULFATE
• TITANIUM DIOXIDE
• TRIACETIN

NDC Codes#

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 30 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 7 · 400 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 · 9 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 10 · 387 observed states.

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 81 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.