FEXOFENADINE HYDROCHLORIDE TABLETS USP, 60mg and 180 mg Allergy

Label at a glance#

Contacts and useful links#

Label contents#

Full prescribing information#

ALLERGYActive ingredient (in each film-coated tablet)

OTC - ACTIVE INGREDIENT SECTION

Fexofenadine HCl USP, 60mg and 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

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 (1800-222-1222).

Directions

DOSAGE & ADMINISTRATION SECTION

FOR 60mg
adults and children 12 years of age and over	take two 60mg tablets with water evrery 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

FOR 180mg
adults and children 12 years of age and over	take one 180mg 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 bottle is torn or missing
• store between 20° and 25°C (68° and 77°F)
• protect from excessive moisture
• each tablet contains: sodium 8.2 mg (for 180mg)
• each tablet contains: sodium 2.7 mg (for 60mg)
• this product meets the requirements of USP Dissolution Test 2

Inactive ingredients

INACTIVE INGREDIENT SECTION

anhydrous lactose, colloidal silicon dioxide, corn starch, croscarmellose sodium, lactose monohydrate, pregelatinized starch (maize), stearic acid, opadry pink 03B84893 containing hypromellose, polyethylene glycol, red iron oxide, titanium dioxide and yellow iron oxide.

Questions or comments?

OTC - QUESTIONS SECTION

Call 1-888-588-1418

Distributed by:
Camber Consumer Care, Inc.
Piscataway, NJ 08854, USA,

Made in USA

HOW SUPPLIED

How Supplied Section

NDC: 71335-0506-1: 30 Tablets in a BOTTLE

NDC: 71335-0506-2: 15 Tablets in a BOTTLE

NDC: 71335-0506-3: 60 Tablets in a BOTTLE

NDC: 71335-0506-4: 90 Tablets in a BOTTLE

NDC: 71335-0506-5: 5 Tablets in a BOTTLE

NDC: 71335-0506-6: 180 Tablets in a BOTTLE

NDC: 71335-0506-7: 100 Tablets in a BOTTLE

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Fexofenadine Hcl 180mg Tablet

FDA-Initiated Inactive NDC Indexing#

DailyMed Billing Units#

Products#

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

DailyMed product names page 1 of 1 · 14 matching rows.

• Fexofenadine HCl
• ANHYDROUS LACTOSE
• SILICON DIOXIDE
• STARCH, CORN
• CROSCARMELLOSE SODIUM
• LACTOSE MONOHYDRATE
• STEARIC ACID
• HYPROMELLOSE, UNSPECIFIED
• POLYETHYLENE GLYCOL, UNSPECIFIED
• FERRIC OXIDE RED
• TITANIUM DIOXIDE
• FERRIC OXIDE YELLOW
• FEXOFENADINE HYDROCHLORIDE
• FEXOFENADINE

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#

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Orange Book products#

Current product rows page 1 of 1 · 4 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 5 · 176 observed states.

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Matched openFDA labels page 1 of 1 · 2 matching rows.

Reported adverse events (FAERS/openFDA)#

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