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good sense levocetirizine

Perrigo Levocetirizine Drug Facts

Approved
Approval ID

0b482364-a00a-4b95-975a-f403a3ae4d2e

Product Type

HUMAN OTC DRUG LABEL

Effective Date

May 20, 2025

Manufacturers
FDA

L. Perrigo Company

DUNS: 006013346

Products 1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

levocetirizine dihydrochloride

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code0113-0241
Application NumberANDA211983
Product Classification
M
Marketing Category
C73584
G
Generic Name
levocetirizine dihydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateMay 20, 2025
FDA Product Classification

INGREDIENTS (7)

LEVOCETIRIZINE DIHYDROCHLORIDEActive
Quantity: 5 mg in 1 1
Code: SOD6A38AGA
Classification: ACTIB
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT

Drug Labeling Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LOINC: 51945-4Updated: 5/20/2025

Package/Label Principal Display Panel

GOODSENSE®

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 24HR

35 Tablets

![goodsense-levocetirizine-carton- image.jpg](/dailymed/image.cfm?name=goodsense-levocetirizine-carton- image.jpg&id=875976)

INDICATIONS & USAGE SECTION

LOINC: 34067-9Updated: 9/15/2020

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

OTC - ACTIVE INGREDIENT SECTION

LOINC: 55106-9Updated: 9/15/2020

Active ingredient (in each tablet)

Levocetirizine dihydrochloride 5 mg

OTC - PURPOSE SECTION

LOINC: 55105-1Updated: 9/15/2020

Purpose

Antihistamine

WARNINGS SECTION

LOINC: 34071-1Updated: 9/15/2020

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).

DOSAGE & ADMINISTRATION SECTION

LOINC: 34068-7Updated: 5/20/2025

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

STORAGE AND HANDLING SECTION

LOINC: 44425-7Updated: 9/15/2020

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 INGREDIENT SECTION

LOINC: 51727-6Updated: 9/15/2020

Inactive ingredients

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

OTC - QUESTIONS SECTION

LOINC: 53413-1Updated: 9/15/2020

Questions or comments?

1-800-719-9260

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good sense levocetirizine - FDA Drug Approval Details