DZA Brands, LLC Aller•Ease Drug Facts

Drug Details [pdf]

HEALTHY ACCENTS ALLER EASE 24 HOUR- fexofenadine hydrochloride tablet, film coated
DZA Brands LLC

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DZA Brands, LLC AllerEase 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 (Blister only)
do not use if printed foil under cap is broken or missing (Bottle 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?

1-866-322-2439

Package/Label Principal Display Panel

Original Prescription Strength

24 Hour

AllerEase

Fexofenadine hydrochloride tablets, 180 mg/antihistamine

Indoor & Outdoor Allergies

Relief of:

Sneezing

Runny Nose

Itchy, Watery Eyes

Itchy Nose or Throat

Non-Drowsy

Actual Size

Compare to Allegra® Allergy Tablets active ingredient

180mg Each

Allergy

AllerEase Carton Image 1

AllerEase Carton Image 2

HEALTHY ACCENTS ALLER EASE 24 HOUR
fexofenadine hydrochloride tablet, film coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 55316-571
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)
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 GLYCOL (UNII: 3WJQ0SDW1A)
POVIDONE (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: 55316-571-22	3 in 1 CARTON	09/22/2011	01/31/2019
1		5 in 1 BLISTER PACK; Type 0: Not a Combination Product
2	NDC: 55316-571-39	1 in 1 CARTON	06/15/2011	08/31/2019
2		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	06/15/2011	08/31/2019

Labeler - DZA Brands LLC (090322194)

Revised: 12/2018

Document Id: 6ebf2d84-3c95-41e5-90d6-01bb70e3aaf1

Set id: 54a251b6-fc8b-43be-bc52-9312ded541af

Version: 2

Effective Time: 20181218