SHOPRITE ALLER EASE- fexofenadine hydrochloride tablet, film coated 
Wakefern Food Corporation

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ShopRite Aller-Ease Drug Facts

Active ingredient (in each tablet)

Fexofenadine HCl 60 mg

Purpose

Antihistamine

Uses

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

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.

If pregnant or breast-feeding,

ask a health professional before use.

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

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

Other information

do not use if blister unit is broken or torn
store at 20°-25°C (68°-77°F)
protect from excessive moisture
this product meets the requirements of USP Dissolution Test 3

Inactive ingredients

colloidal silicon dioxide, croscarmellose sodium, hypromellose, iron oxide black, iron oxide red, iron oxide yellow, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, titanium dioxide

Questions or comments?

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Compare to: Active Ingredient in Allegra® Allergy Tablets

ALLERGY

ORIGINAL PRESCRIPTION STRENGTH

ALLER-EASE

Fexofenadine Hydrochloride Tablets, 60 mg/Antihistamine

INDOOR & OUTDOOR ALLERGIES

12 Hour

Relief of Sneezing; Runny Nose; Itchy, Watery Eyes; Itchy Nose or Throat

Non-Drowsy

actual size

12 tablets 60 mg each

ShopRite Aller-Ease.jpg
ShopRite Aller-Ease.jpg
SHOPRITE ALLER EASE 
fexofenadine hcl tablet, film coated
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:41190-425
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
FEXOFENADINE HYDROCHLORIDE (UNII: 2S068B75ZU) (FEXOFENADINE - UNII:E6582LOH6V) FEXOFENADINE HYDROCHLORIDE 60 mg
Inactive Ingredients
Ingredient Name Strength
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
HYPROMELLOSES (UNII: 3NXW29V3WO)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A)  
POVIDONES (UNII: FZ989GH94E)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
Product Characteristics
Color ORANGE (Peach) Score no score
Shape ROUND Size 8mm
Flavor Imprint Code 93;7252
Contains     
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:41190-425-53 2 in 1 CARTON
1 6 in 1 BLISTER PACK
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA076447 07/09/2013
Labeler - Wakefern Food Corporation (069722418)

Revised: 9/2013
Document Id: 610cfc7f-d046-4425-9199-47e6c3214128
Set id: 610cfc7f-d046-4425-9199-47e6c3214128
Version: 1
Effective Time: 20130912
 
Wakefern Food Corporation