ALLER EASE- fexofenadine hydrochloride tablet, film coated 
Meijer Distribution Inc

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Meijer Distribution, Inc. Aller•Ease Drug Facts

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
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 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

do not use if blister unit is broken or torn (Use for Blister Configuration Only)
do not use if printed foil under cap is broken or missing (Use for Bottle Configuration Only)
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?

1-800-719-9260

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Compare to Allegra® Allergy active ingredient

Allergy

Aller•Ease

Fexofenadine Hydrochloride Tablets, 180 mg/Antihistamine

Original Prescription Strength

Non-Drowsy

Relief of:

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

Actual Size

24 Hour

Indoor & Outdoor Allergies

30 Tablets 180 mg Each

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Aller•Ease Carton Image 1

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Aller•Ease Carton Image 2

ALLER EASE 
fexofenadine hydrochloride tablet, film coated
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:41250-571
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 180 mg
Inactive Ingredients
Ingredient Name Strength
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
HYPROMELLOSES (UNII: 3NXW29V3WO)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
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)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
Product Characteristics
Color ORANGE (peach) Score no score
Shape ROUND Size 12mm
Flavor Imprint Code 93;7253
Contains     
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:41250-571-22 15 in 1 CARTON
1 1 in 1 BLISTER PACK
2 NDC:41250-571-39 1 in 1 CARTON
2 30 in 1 BOTTLE
3 NDC:41250-571-95 1 in 1 CARTON
3 45 in 1 BOTTLE
4 NDC:41250-571-47 1 in 1 CARTON
4 150 in 1 BOTTLE
5 NDC:41250-571-75 2 in 1 CARTON
5 45 in 1 BOTTLE
6 NDC:41250-571-49 1 in 1 CARTON
6 40 in 1 BOTTLE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA076447 04/14/2011
Labeler - Meijer Distribution Inc (006959555)

Revised: 3/2014
Document Id: 376ae6f9-400c-4edd-b342-f587de0ebed0
Set id: 4fa68cd5-ca88-489d-9ae5-0887364aaf3e
Version: 4
Effective Time: 20140310
 
Meijer Distribution Inc