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NDC 00113-0241-01 good sense levocetirizine 5 mg/1 Details

good sense levocetirizine 5 mg/1

good sense levocetirizine is a ORAL TABLET, FILM COATED in the HUMAN OTC DRUG category. It is labeled and distributed by L. Perrigo Company. 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: 00113-0241-01
Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Levocetirizine

Product Information

NDC	00113-0241
Product ID	0113-0241_0b482364-a00a-4b95-975a-f403a3ae4d2e
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	good sense levocetirizine
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	L. Perrigo Company
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 00113-0241-01 (00113024101)

Pricing Information	N/A
NDC Package Code	0113-0241-01
Billing NDC	00113024101
Package	1 BOTTLE in 1 CARTON (0113-0241-01) / 35 TABLET, FILM COATED in 1 BOTTLE
Marketing Start Date	2020-09-11
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 0b482364-a00a-4b95-975a-f403a3ae4d2e 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 printed foil under cap is broken or missing

Inactive ingredients

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

Questions or comments?

1-800-719-9260

Package/Label Principal Display Panel

Allergy

Original Prescription Strength

Levocetirizine

Dihydrochloride Tablets, 5 mg

Antihistamine

Actual Size

24 Hour Relief of:

Sneezing

Runny Nose

Itchy Nose or Throat

Itchy, Watery Eyes

Compare to active ingredient of XYZAL® Allergy 24 HR

100% SATISFACTION GUARANTEED

35 Tablets

INGREDIENTS AND APPEARANCE

GOOD SENSE LEVOCETIRIZINE

levocetirizine dihydrochloride tablet, film coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:0113-0241
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:0113-0241-01	1 in 1 CARTON	09/11/2020
1		35 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	09/11/2020

Labeler - L. Perrigo Company (006013346)

Revised: 9/2020

Document Id: 0b482364-a00a-4b95-975a-f403a3ae4d2e

Set id: 0b482364-a00a-4b95-975a-f403a3ae4d2e

Version: 1

Effective Time: 20200915