ALLERGY RELIEF- levocetirizine dihydrochloride tablet, coated
AMERISOURCEBERGEN DRUG CORPORATION

----------

Drug Facts

Active ingredient (in each tablet)

Levocetirizine dihydrochloride USP, 5 mg

Purpose

Antihistamine

Uses

temporarily relieves these symptoms due to hay fever or other respiratory allergies:

runny nose
sneezing
itchy, watery eyes
itching of the nose or throat

Warnings

Do not use

if you have kidney disease
if you have ever had an allergic reaction to this product or any of its ingredients or to an antihistamine containing cetirizine

Ask a doctor before use if you have

ever had trouble urinating or emptying your bladder

When using this product

drowsiness may occur
avoid alcoholic drinks
alcohol, sedatives, and tranquilizers may increase drowsiness
be careful when driving a motor vehicle or operating machinery

Stop use and ask doctor if

you have trouble urinating or emptying your bladder
an allergic reaction to this product occurs. Seek medical help right away.

If pregnant or breast-feeding:

if breast-feding: not recommended
if pregnant: 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 65 years of age and older	ask a doctor
adults and children 12-64 years of age	take 1 tablet (5 mg) once daily in the evening do not take more than 1 tablet (5 mg) in 24 hours 1/2 tablet (2.5 mg) once daily in the evening may be appropriate for less severe symptoms
children 6-11 years of age	take 1/2 tablet (2.5 mg) once daily in the evening do not take more than 1/2 tablet (2.5 mg) in 24 hours
children under 6 years of age	do not use
consumers with kidney disease	do not use

Other information

store between 20° and 25°C (68° and 77°F)
safety sealed: do not use if carton was opened or if printed foil inner seal on bottle is torn or missing

Inactive ingredients

colloidal silicon dioxide, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, titanium dioxide

Questions or comments?

Call 1-888-375-3784

Carton Label

Compare to Xyzal® Allergy 24HR
active ingredient*

Good
Neighbor
Pharmacy®

ORIGINAL PRESCRIPTION STRENGTH

Allergy Relief
levocetirizine dihydrochloride
tablets USP, 5 mg
Antihistamine

Relief of:

Sneezing
Runny Nose
Itchy Nose or Throat
Itchy, Watery Eyes

24 HOUR

carton

Bottle Label

Good
Neighbor
Pharmacy®

ORIGINAL PRESCRIPTION STRENGTH

Allergy Relief
levocetirizine
dihydrochloride
tablets USP, 5 mg
Antihistamine

24 HOUR

Label

ALLERGY RELIEF
levocetirizine dihydrochloride tablet, coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:46122-531
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
levocetirizine dihydrochloride (UNII: SOD6A38AGA) (levocetirizine - UNII:6U5EA9RT2O)	levocetirizine dihydrochloride	5 mg

Ingredient Name	Strength
Inactive Ingredients
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
MAGNESIUM STEARATE (UNII: 70097M6I30)
HYPROMELLOSES (UNII: 3NXW29V3WO)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
Polyethylene Glycol, Unspecified (UNII: 3WJQ0SDW1A)

Product Characteristics
Color	white	Score	2 pieces
Shape	OVAL	Size	9mm
Flavor		Imprint Code	L
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:46122-531-05	1 in 1 CARTON	04/20/2018
1		35 in 1 BOTTLE; Type 0: Not a Combination Product
2	NDC:46122-531-52	2 in 1 CARTON	07/06/2018
2		5 in 1 BLISTER PACK; Type 0: Not a Combination Product
3	NDC:46122-531-61	1 in 1 CARTON	09/01/2023
3		80 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	ANDA210375	04/20/2018

Labeler - AMERISOURCEBERGEN DRUG CORPORATION (007914906)

Revised: 8/2023

Document Id: 7ac146e8-8009-f57f-2966-5fac830d67b9

Set id: fdf54de3-16a9-3b28-b4c4-d745322b3d3c

Version: 6

Effective Time: 20230830

AMERISOURCEBERGEN DRUG CORPORATION