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

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ShopRite 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 printed foil under cap is broken or missing
•: 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, 180 mg/Antihistamine

INDOOR & OUTDOOR ALLERGIES

24 Hour

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

Non-Drowsy

actual size

70 TABLETS 180 mg EACH

SHOPRITE ALLER EASE
fexofenadine hcl tablet, film coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:41190-571
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
FEXOFENADINE HYDROCHLORIDE (UNII: 2S068B75ZU) (FEXOFENADINE - UNII:E6582LOH6V)	FEXOFENADINE HYDROCHLORIDE	180 mg

Ingredient Name	Strength
Inactive Ingredients
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)
MAGNESIUM STEARATE (UNII: 70097M6I30)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Product Characteristics
Color	ORANGE (peach)	Score	no score
Shape	ROUND	Size	12mm
Flavor		Imprint Code	93;7253
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:41190-571-22	3 in 1 CARTON	07/09/2013	06/30/2019
1		5 in 1 BLISTER PACK; Type 0: Not a Combination Product
2	NDC:41190-571-95	1 in 1 CARTON	08/06/2013	12/12/2017
2		45 in 1 BOTTLE; Type 0: Not a Combination Product
3	NDC:41190-571-01	1 in 1 CARTON	10/24/2016	02/05/2018
3		70 in 1 BOTTLE; Type 0: Not a Combination Product
4	NDC:41190-571-39	1 in 1 CARTON	06/07/2016	02/18/2019
4		30 in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
ANDA	ANDA076447	07/09/2013	06/30/2019

Labeler - Wakefern Food Corporation (069722418)

Revised: 12/2020

Document Id: 85ef0a65-e4e3-4336-babc-0a35d6729a11

Set id: 64fce94c-3a1c-45f9-a556-945d966bf9e0

Version: 4

Effective Time: 20201202

Wakefern Food Corporation