Active ingredient (in each tablet)

Levocetirizine dihydrochloride 5 mg

Purpose

Antihistamine

Uses

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

•: runny nose
•: itchy, watery eyes
•: sneezing
•: 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 a 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-feeding: 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 • ½ tablet (2.5 mg) once daily in the evening may be appropriate for less severe symptoms
children 6-11 years of age	• take ½ tablet (2.5 mg) once daily in the evening • do not take more than ½ 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)
•: do not use if blister unit is broken or torn

Inactive ingredients

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

Questions or comments?

1-888-423-0139

Package/Label Principal Display Panel

TopCare® health

COMPARE TO XYZAL® ALLERGY 24HR ACTIVE INGREDIENT

ORIGINAL PRESCRIPTION STRENGTH

All Day Allergy

LEVOCETIRIZINE DIHYDROCHLORIDE TABLETS, 5 mg

ANTIHISTAMINE

INDOOR & OUTDOOR ALLERGIES

24 HOUR

RELIEF OF:

• Sneezing • Runny Nose

• Itchy Nose or throat

• Itchy, Watery Eyes

10 TABLETS

actual size

TOPCARE ALL DAY ALLERGY
levocetirizine dihydrochloride tablet, film coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:36800-241
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
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)
MAGNESIUM STEARATE (UNII: 70097M6I30)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Product Characteristics
Color	WHITE	Score	2 pieces
Shape	OVAL	Size	8mm
Flavor		Imprint Code	L9CZ;5
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:36800-241-01	1 in 1 CARTON	02/05/2020
1		35 in 1 BOTTLE; Type 0: Not a Combination Product
2	NDC:36800-241-46	10 in 1 CARTON	03/09/2020
2		1 in 1 BLISTER PACK; Type 0: Not a Combination Product
3	NDC:36800-241-95	1 in 1 CARTON	10/07/2020
3		45 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	ANDA211983	02/05/2020

Labeler - Topco Associates LLC (006935977)

Topco Associates LLC. All Day Allergy Drug Facts