® Tablets

Label at a glance#

Contacts and useful links#

PhonePoison Help1-800-222-1222

PhoneLabel contact1-888-588-1418

PhoneLabel contact(800) 616-2471

Websitewww.majorpharmaceuticals.comwww.majorpharmaceuticals.com

Label contents#

Full prescribing information#

ALLERGY Active ingredient (in each film-coated tablet)

OTC - ACTIVE INGREDIENT SECTION

Fexofenadine HCl USP 60 mg
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
• 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.

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

Directions (for 60mg)

adults and children 12 years of age and over	take one 60mg 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

Directions (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

STORAGE AND HANDLING SECTION

• store between 20° and 25°C (68° and 77°F)
• protect from excessive moisture
• each tablet contains:sodium 2.7 mg (for 60 mg), sodium 8.2 mg (for 180 mg)
• this product meets the requirements of USP Dissolution Test 2

Inactive ingredients

INACTIVE INGREDIENT SECTION

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

OTC - QUESTIONS SECTION

Questions or comments?

Call toll-free 1-888-588-1418
Monday-Friday 9AM-7PM EST

Distributed by: MAJOR ^®PHARMACEUTICALS
Indianapolis, IN 46268
(800) 616-2471
www.majorpharmaceuticals.com

HOW SUPPLIED

How Supplied Section

Fexofenadine Hydrochloride 60mg Tablets 

• NDC 71335-2165-1: 30 Tablets in a BOTTLE
• NDC 71335-2165-2: 10 Tablets in a BOTTLE
• NDC 71335-2165-3: 60 Tablets in a BOTTLE
• NDC 71335-2165-4: 90 Tablets in a BOTTLE
• NDC 71335-2165-5: 14 Tablets in a BOTTLE
• NDC 71335-2165-6: 20 Tablets in a BOTTLE
• NDC 71335-2165-7: 12 Tablets in a BOTTLE

store between 20° and 25°C (68° and 77°F). protect from excessive moisture.

Repackaged/Relabeled by:
Bryant Ranch Prepack, Inc.
Burbank, CA 91504

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Fexofenadine Hydrochloride 60mg Tablets

DailyMed RxNorm Mappings#

DailyMed Pharmacologic Classes#

Product Linked Resources#

Resource, Code type, Value table

Resource	Code type	Value	Equivalent identifiers	Source image
Barcode	Data Matrix	(01)00371335216511(21)0123456789(17)271022(10)208820	GTIN-14: 00371335216511 GTIN-12: 371335216511 UPC-A: 371335216511 EAN-13: 0371335216511 GTIN storage (14 digits): 00371335216511	lbl713352165.jpg
QR code link	QR Code	dailymed.nlm.nih.gov/dailymed/search.cfm?adv=1&query=NDC:71335-2165-1		lbl713352165.jpg
Data code	Code 128	7133521651		lbl713352165.jpg

DailyMed Product Concepts#

DailyMed Package Descriptions#

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

Older Hydrated Versions#

Orange Book application contexts#

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Orange Book application contexts page 1 of 1 · 1 matching rows.

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.