CARE ONE ALLER EASE- fexofenadine hydrochloride tablet, film coated 
American Sales Company

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American Sales Company 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 overtake one 180 mg tablet with water once a day; do not take more than 1 tablet in 24 hours
children under 12 years of agedo not use
adults 65 years of age and olderask a doctor
consumers with kidney diseaseask 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 the Active Ingredient in Allegra® Allergy Tablets

24 Hour

Original Prescription Strength

ALLER•EASE

Fexofenadine Hydrochloride Tablets, 180 mg

Antihistamine

ALLERGY

Actual Size

Relief of:

Sneezing

Runny Nose

Itchy, Watery Eyes

Itchy Nose or Throat

Non-Drowsy

Indoor & Outdoor Allergies

180 mg EACH

Aller•Ease Carton Image 1

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Aller•Ease Carton Image 2

CARE ONE ALLER EASE 
fexofenadine hydrochloride tablet, film coated
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:41520-571
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 RED 
FERRIC OXIDE YELLOW 
LACTOSE MONOHYDRATE 
MAGNESIUM STEARATE 
CELLULOSE, MICROCRYSTALLINE 
POLYETHYLENE GLYCOLS 
POVIDONE 
TITANIUM DIOXIDE 
Product Characteristics
ColorORANGE (peach) Scoreno score
ShapeROUNDSize12mm
FlavorImprint Code 93;7253
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:41520-571-223 in 1 CARTON
15 in 1 BLISTER PACK
2NDC:41520-571-391 in 1 CARTON
230 in 1 BOTTLE
3NDC:41520-571-951 in 1 CARTON
345 in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07644704/15/2011
Labeler - American Sales Company (809183973)

Revised: 11/2011
Document Id: 3f6c85a7-a2b9-442c-8d8a-c858c1f674fe
Set id: 3f6c85a7-a2b9-442c-8d8a-c858c1f674fe
Version: 1
Effective Time: 20111121
 
American Sales Company