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aller ease by Meijer Distribution Inc

Dosage form: tablet, film coated
Ingredients: FEXOFENADINE HYDROCHLORIDE 180mg
Labeler: Meijer Distribution Inc
NDC Code: 41250-571

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

Package/Label Principal Display Panel

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

Aller•Ease Carton Image 1

Aller•Ease Carton Image 2

ALLER EASE 
fexofenadine hydrochloride tablet, film coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:41250-571
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
FEXOFENADINE HYDROCHLORIDE (FEXOFENADINE) FEXOFENADINE HYDROCHLORIDE180 mg
Inactive Ingredients
Ingredient NameStrength
SILICON DIOXIDE 
CROSCARMELLOSE SODIUM 
HYPROMELLOSES 
FERROSOFERRIC OXIDE 
FERRIC OXIDE YELLOW 
LACTOSE MONOHYDRATE 
MAGNESIUM STEARATE 
CELLULOSE, MICROCRYSTALLINE 
POLYETHYLENE GLYCOLS 
POVIDONES 
TITANIUM DIOXIDE 
FERRIC OXIDE RED 
Product Characteristics
ColorORANGE (peach) Scoreno score
ShapeROUNDSize12mm
FlavorImprint Code93;7253
Contains    
Packaging
#Item CodePackage Description
1NDC:41250-571-2215 BLISTER PACK in 1 CARTON
11 TABLET, FILM COATED in 1 BLISTER PACK
2NDC:41250-571-391 BOTTLE in 1 CARTON
230 TABLET, FILM COATED in 1 BOTTLE
3NDC:41250-571-951 BOTTLE in 1 CARTON
345 TABLET, FILM COATED in 1 BOTTLE
4NDC:41250-571-471 BOTTLE in 1 CARTON
4150 TABLET, FILM COATED in 1 BOTTLE
5NDC:41250-571-752 BOTTLE in 1 CARTON
545 TABLET, FILM COATED in 1 BOTTLE
6NDC:41250-571-491 BOTTLE in 1 CARTON
640 TABLET, FILM COATED in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07644704/14/2011
Labeler - Meijer Distribution Inc (006959555)

Revised: 03/2014
 
Meijer Distribution Inc

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Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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