Fexofenadine Hydrochloride Tablets USP, 180 mg

Label at a glance#

Contacts and useful links#

Label contents#

Full prescribing information#

ACTIVE INGREDIENT(S), in each tablet

OTC - ACTIVE INGREDIENT SECTION

Fexofenadine hydrochloride 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

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

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 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, 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

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

OTHER INFORMATION

SPL UNCLASSIFIED SECTION

•  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 INGREDIENTS

INACTIVE INGREDIENT SECTION

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.

QUESTIONS OR COMMENTS

OTC - QUESTIONS SECTION

call toll-free weekdays 9 AM to 5 PM EST at 1-888-588-1418

Fexofenadine HCL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

DailyMed Billing Units#

Products#

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

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

• Fexofenadine HCL
• FEXOFENADINE HYDROCHLORIDE
• FEXOFENADINE
• SILICA
• HYPROMELLOSE 2910 (6 MPA.S)
• LIGHT MINERAL OIL
• MAGNESIUM STEARATE
• CELLULOSE, MICROCRYSTALLINE
• POLYSORBATE 80
• STARCH, CORN
• FERRIC OXIDE
• FERRIC OXIDE YELLOW
• SODIUM STARCH GLYCOLATE TYPE A POTATO
• TALC
• CI 77891
• PEG-135

NDC Codes#

Ingredients#

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DailyMed ingredient rows page 1 of 1 · 14 matching rows.

Source Document#

Source XML

Orange Book application contexts#

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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 · 135 observed states.

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Reported adverse events (FAERS/openFDA)#

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