Levocetirizine Dihydrochloride Tablets USP, 5 mg (OTC)

Label at a glance#

Contacts and useful links#

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 1-888-588-1418.

 

Distributed by:
Camber Consumer Care, Inc.

Piscataway, NJ 08854, USA.

LEVOCETIRIZINE DIHYDROCHLORIDE TABLET, FILM COATED

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

DailyMed RxNorm Mappings#

DailyMed Pharmacologic Classes#

DailyMed Product Concepts#

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

DailyMed Dashboard NDC Coverage#

DailyMed Billing Units#

Products#

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

DailyMed product names page 1 of 1 · 11 matching rows.

• Levocetirizine Dihydrochloride
• LEVOCETIRIZINE
• LACTOSE MONOHYDRATE
• MICROCRYSTALLINE CELLULOSE
• SILICON DIOXIDE
• MAGNESIUM STEARATE
• TITANIUM DIOXIDE
• HYPROMELLOSE 2910 (3 MPA.S)
• HYPROMELLOSE 2910 (6 MPA.S)
• POLYETHYLENE GLYCOL 400
• POLYSORBATE 80

NDC Codes#

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 10 matching rows.

Source Document#

Source XML

Orange Book application contexts#

All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.

Orange Book application contexts page 1 of 1 · 1 matching rows.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

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 · 2 matching rows.

Reported adverse events (FAERS/openFDA)#

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