TOPCARE ALL DAY ALLERGY- levocetirizine dihydrochloride tablet, film coated

Topcare All Day Allergy by

Drug Labeling and Warnings

Topcare All Day Allergy by is a Otc medication manufactured, distributed, or labeled by Topco Associates LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

COMPARE TO XYZAL® ALLERGY 24HR ACTIVE INGREDIENT

ORIGINAL PRESCRIPTION STRENGTH

All Day Allergy

LEVOCETIRIZINE DIHYDROCHLORIDE TABLETS, 5 mg

ANTIHISTAMINE

OUR PHARMACISTS RECOMMEND

INDOOR & OUTDOOR ALLERGIES

24 HOUR

RELIEF OF:

Sneezing

Runny Nose

Itchy Nose or throat

Itchy, Watery Eyes

10 TABLETS

actual size

INGREDIENTS AND APPEARANCE

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

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

Inactive Ingredients
Ingredient Name	Strength
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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
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

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA211983	02/05/2020

Labeler - Topco Associates LLC (006935977)