FDA Label for Allergy Relief

View Indications, Usage & Precautions

ACTIVE INGREDIENT (IN EACH TABLET)
PURPOSE
USES
DO NOT USE
ASK A DOCTOR BEFORE USE IF YOU HAVE
WHEN USING THIS PRODUCT:
STOP USE AND ASK A DOCTOR IF
OTC - PREGNANCY OR BREAST FEEDING
OTC - KEEP OUT OF REACH OF CHILDREN
DIRECTIONS
OTHER INFORMATION
INACTIVE INGREDIENTS
QUESTIONS?
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Allergy Relief Product Label

The following document was submitted to the FDA by the labeler of this product Bi-mart. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

Active Ingredient (In Each Tablet)

Fexofenadine HCl 180 mg

Purpose

Antihistamine

Uses

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

if you have ever had an allergic reaction to this product or any of its ingredients.

Ask A Doctor Before Use If You Have

kidney disease. Your doctor should determine if you need a different dose.

When Using This Product:

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

an allergic reaction to this product occurs. Seek medical help right away.

Otc - Pregnancy Or Breast Feeding

If pregnant or breast-feeding,

ask a health professional before use.

Otc - Keep Out Of Reach Of Children

Keep out of reach of children.

In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Directions

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

store between 20° and 25°C (68° and 77°F)
protect from excessive moisture
each tablet contains: sodium 8 mg
this product meets the requirements of USP Dissolution Test 2

Inactive Ingredients

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

Questions?

Call toll-free 1-844-912-4012

Package Label.Principal Display Panel

NDC 37835-601-09

COMPARE TO THE ACTIVE INGREDIENT IN ALLEGRA ^®ALLERGY 24 HOUR TABLETS*

NON-DROWSY

ALLERGY RELIEF

FEXOFENADINE HYDROCHLORIDE 180 mg

24 HOUR ALLERGY

ORIGINAL PRESCRIPTION STRENGTH

RELIEF OF:

SNEEZING

RUNNY NOSE

ITCHY, WATER EYES

ITCHY NOSE OR THROAT

ANTIHISTAMINE

90 Tablets

*This product is not manufactured or distributed by the owner of the registered trademark Allegra ^®Allergy 24 Hour Tablets.

Distributed by:

BI-MART

Eugene, OR 97402

NDC 37835-601-45