Levocetirizine Dihydrochloride Tablets USP, 5 mg (OTC)

Manufacturer
Safrel Pharmaceuticals LLC
Effective date
2023-02-14
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:54:11

Label at a glance#

ProductLevocetirizine Dihydrochloride
Active ingredientLEVOCETIRIZINE DIHYDROCHLORIDE
Label structure14 sections

Dosage and administration

                 adults 65 years of age and older     ask a doctor    adults and children 12 to 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 to 11 years of age     take ½ tablet (2.5 mg) once daily in the evening  do not take more than ½ ta...

Label contents#

Full prescribing information#

ACTIVE INGREDIENT(S)

OTC - ACTIVE INGREDIENT SECTION

Levocetirizine dihydrochloride USP 5 mg


PURPOSE

OTC - PURPOSE SECTION

Antihistamine

USE(S)

INDICATIONS & USAGE SECTION

temporarily relieves these symptoms due to hay fever or other respiratory allergies:
• runny nose
• sneezing
• itchy, watery eyes
• itching of the nose or throat


DO NOT USE

OTC - DO NOT USE SECTION

• 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

OTC - ASK DOCTOR SECTION

  • ever had trouble urinating or emptying your bladder

WHEN USING THIS PRODUCT

OTC - WHEN USING SECTION

  •  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

OTC - STOP USE SECTION

• 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

OTC - PREGNANCY OR BREAST FEEDING SECTION

  • if breast-feeding: not recommended 
  •  if pregnant: ask a health professional before use

KEEP OUT OF REACH OF CHILDREN

OTC - KEEP OUT OF REACH OF CHILDREN SECTION


In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222).

DIRECTIONS

DOSAGE & ADMINISTRATION SECTION

               

 adults 65 years of age and older
 
 
  • ask a doctor
 
 adults and children 12 to 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 to 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

SPL UNCLASSIFIED SECTION

• store between 20° and 25°C (68° and 77°F)
• safety sealed: do not use if carton was opened or if printed foil inner seal on bottle is torn or missing
• safety sealed: do not use if carton was opened or if individual blister unit is open or torn



INACTIVE INGREDIENTS

INACTIVE INGREDIENT SECTION


colloidal silicon dioxide, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, titanium dioxide.

QUESTIONS or COMMENTS?

SPL UNCLASSIFIED SECTION

call 1-844-384-3723.

Distributed by:
Safrel Pharmaceuticals, LLC

Bridgewater, NJ 08807

www.safrel.com

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Levocetirizine Dihydrochloride Tablets USP 5 mg-180 Tablets



Compare to XYZAL ® Allergy 24HR Active Ingredient*

Allergy Relief

Levocetirizine Dihydrochloride

Tablets, USP

5 mg

Antihistamine

24 HOUR Relief of

  • Sneezing
  • Runny Nose
  • Itchy Nose or Throat
  • Itchy, Watery Eyes

Original Prescription Strength

180 TABLETS

levolevo

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
855172levocetirizine dihydrochloride 5 MG Oral TabletPSN1
855172levocetirizine dihydrochloride 5 MG Oral TabletSCD1
855172levocetirizine dihydrochloride 5 MG 24 HR Oral TabletSY1

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
LEVOCETIRIZINE Pharmacologic Class Indexing3Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
36cf9111-9cc4-8f59-a74c-0c1cfbd4a760Product name720190702

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71309-112-18Levocetirizine Dihydrochloride180 in 1 BOTTLETABLET, FILM COATED1801

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71309-112LEVOCETIRIZINE DIHYDROCHLORIDE TABLET, FILM COATED [SAFREL PHARMACEUTICALS LLC]11 package rows20230221_f4aba1d6-2516-3b8a-e053-2995a90a5626.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 10 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
71309-11271309-112-18

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 9 matching rows.

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
f4ab9fca-5fb1-518a-e053-2a95a90a3420f4aba1d6-2516-3b8a-e053-2995a90a56262023-02-14Exact identifier
spl id: f4ab9fca-5fb1-518a-e053-2a95a90a3420
spl set id: f4aba1d6-2516-3b8a-e053-2995a90a5626

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.