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NDC 36800-0241-46 Topcare All Day Allergy 5 mg/1 Details

Topcare All Day Allergy 5 mg/1

Topcare All Day Allergy is a ORAL TABLET, FILM COATED in the HUMAN OTC DRUG category. It is labeled and distributed by Topco Associates LLC. The primary component is LEVOCETIRIZINE DIHYDROCHLORIDE.

MedlinePlus Drug Summary

Levocetirizine is used to relieve runny nose; sneezing; and redness, itching, and tearing of the eyes caused by hay fever, seasonal allergies, and allergies to other substances such as dust mites, animal dander, and mold. It is also used to treat symptoms of hives, including itching and rash. Levocetirizine is in a class of medications called antihistamines. It works by blocking the action of histamine, a substance in the body that causes allergic symptoms.

Related Packages: 36800-0241-46
Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Levocetirizine

Product Information

NDC	36800-0241
Product ID	36800-241_e685d7d8-ba5f-424a-9a98-54bde72bfacf
Associated GPIs
GCN Sequence Number	n/a
GCN Sequence Number Description	n/a
HIC3	n/a
HIC3 Description	n/a
GCN	n/a
HICL Sequence Number	n/a
HICL Sequence Number Description	n/a
Brand/Generic	n/a
Proprietary Name	Topcare All Day Allergy
Proprietary Name Suffix	n/a
Non-Proprietary Name	levocetirizine dihydrochloride
Product Type	HUMAN OTC DRUG
Dosage Form	TABLET, FILM COATED
Route	ORAL
Active Ingredient Strength	5
Active Ingredient Units	mg/1
Substance Name	LEVOCETIRIZINE DIHYDROCHLORIDE
Labeler Name	Topco Associates LLC
Pharmaceutical Class	Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]
DEA Schedule	n/a
Marketing Category	ANDA
Application Number	ANDA211983
Listing Certified Through	2024-12-31

Package

Package Images

NDC 36800-0241-46 (36800024146)

Pricing Information	N/A
NDC Package Code	36800-241-46
Billing NDC	36800024146
Package	10 BLISTER PACK in 1 CARTON (36800-241-46) / 1 TABLET, FILM COATED in 1 BLISTER PACK
Marketing Start Date	2020-03-09
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 393616df-52f1-4e77-b69c-8239ca193d5b Details

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

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

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)

Revised: 2/2022

Document Id: e685d7d8-ba5f-424a-9a98-54bde72bfacf

Set id: 393616df-52f1-4e77-b69c-8239ca193d5b

Version: 4

Effective Time: 20220221