Fexofenadine Hydrochloride Tablets, USP 180 mg

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Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

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
• itchy, watery eyes
• sneezing
• itching of the nose or throat

Warnings

WARNINGS SECTION

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.

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)

OTC - STOP USE SECTION

Stop use and ask a doctor if an allergic reaction to this product occurs. Seek medical help right away.

OTC - PREGNANCY OR BREAST FEEDING SECTION

If pregnant or breast-feeding, ask a health professional before use.

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 (1-800-222-1222).

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

STORAGE AND HANDLING SECTION

• safety sealed: do not use if carton is opened or if inner safety seal is torn or missing
• store between 20° to 25°C (68° to 77°F)
• protect from excessive moisture

Inactive ingredients

INACTIVE INGREDIENT SECTION

croscarmellose sodium, hypromellose, iron oxide red, iron oxide yellow, magnesium stearate, microcrystalline cellulose, polyethylene glycol, pregelatinized maize starch, titanium dioxide

Questions or comments?

OTC - QUESTIONS SECTION

Call toll-free weekdays 8:30 AM to 5 PM EST at 1-800-818-4555.

SPL UNCLASSIFIED SECTION

Distributed by:
Ohm Laboratories Inc.
New Brunswick, NJ 08901
MADE IN INDIA

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Product Linked Resources#

DailyMed Billing Units#

Products#

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

DailyMed product names page 1 of 1 · 10 matching rows.

• FEXOFENADINE HYDROCHLORIDE
• FEXOFENADINE
• CROSCARMELLOSE SODIUM
• STARCH, CORN
• MAGNESIUM STEARATE
• HYPROMELLOSE, UNSPECIFIED
• TITANIUM DIOXIDE
• POLYETHYLENE GLYCOL 400
• FERRIC OXIDE RED
• FERRIC OXIDE YELLOW

NDC Codes#

Ingredients#

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DailyMed ingredient rows page 1 of 1 · 9 matching rows.

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Orange Book products#

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Observed Orange Book product history#

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Product history page 1 of 7 · 264 observed states.

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Reported adverse events (FAERS/openFDA)#

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