Levocetirzine Dihydrochloride Tablets USP, 5 mg

Manufacturer: Chain Drug Marketing Association INC | Dr.Reddy's Laboratories Limited-FTO 3 | Reed-Lane, Inc.
Effective date: 2025-12-10
Label type: HUMAN OTC DRUG LABEL
Version: 3
Source: full-release
Hydrated at: 2026-06-01 01:22:14

Label at a glance#

Productlevocetirizine dihydrochloride

Active ingredientlevocetirizine dihydrochloride

Label structure11 sections

Indications and uses

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

Dosage and administration

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 1/2 tablet (2.5 mg) once daily in the evening may be appropriate for less severe symptoms children 6-11 years of age take 1/2 tablet (2.5 mg) once daily in the evening do not take more than 1/2 tablet (2.5 mg) in 24 hours children unde...

Contacts and useful links#

PhonePoison Help1-800-222-1222

PhoneLabel contact1-888-375-3784

Label contents#

Full prescribing information#

SPL PRODUCT DATA ELEMENTS SECTION

SPL UNCLASSIFIED SECTION

Active ingredient (in each tablet)

OTC - ACTIVE INGREDIENT SECTION

Levocetirizine dihydrochloride USP, 5 mg

Purpose

OTC - PURPOSE SECTION

Antihistamine

Uses

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

Warnings

WARNINGS SECTION

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 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-feding: 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 12-64 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 1/2 tablet (2.5 mg) once daily in the evening may be appropriate for less severe symptoms
children 6-11 years of age	take 1/2 tablet (2.5 mg) once daily in the evening do not take more than 1/2 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)
(bottles only) safety sealed: do not use if carton was opened or if printed foil inner seal on bottle is torn or missing
(blister only) safety sealed: do not use if seal is broken 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, titanium dioxide

Questions or comments?

OTC - QUESTIONS SECTION

Call 1-888-375-3784

Levocetirizine Dihydrochloride Tablets, USP 5 mg carton label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Original Prescription Strength

Levocetirizine
Dihydrochloride
Tablets USP, 5 mg
Antihistamine

ALLERGY

24 HOUR

Relief of:

Sneezing
Runny Nose
Itchy Nose or Throat
Itchy, Watery Eyes

35 Tablets

Carton

Levocetirizine Dihydrochloride Tablets USP, 5 mg bottle label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Original Prescription Strength
Levocetirizine
Dihydrochloride Tablets USP, 5 mg
Antihistamine

ALLERGY

24 HOUR

35 Tablets

Container

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
855172	levocetirizine dihydrochloride 5 MG Oral Tablet	PSN	3
855172	levocetirizine dihydrochloride 5 MG Oral Tablet	SCD	3
855172	levocetirizine dihydrochloride 5 MG 24 HR Oral Tablet	SY	3

DailyMed Pharmacologic Classes#

Class, Version, Type table
Class	Version	Type	Effective
LEVOCETIRIZINE Pharmacologic Class Indexing	3	Indexing - Pharmacologic Class	20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
36cf9111-9cc4-8f59-a74c-0c1cfbd4a760	Product name	7	20190702

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
63868-473-35	levocetirizine dihydrochloride	35 in 1 BOTTLE	TABLET, COATED	35		3
63868-473-35	levocetirizine dihydrochloride	1 in 1 CARTON	TABLET, COATED	1		3

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
63868-473-35	EA - Each	63868-473	a6073c9c-05bc-48c4-b483-789737d804f4	1	2022-09-12
43598-735-30	EA - Each	43598-735	f63cfcf2-4da8-499a-bfc3-df6f91d40e05	1	2024-09-09
43598-735-90	EA - Each	43598-735	9046de29-e000-4f9e-a13e-a7b3f0a92658	1	2024-09-09

Products#

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

DailyMed product names page 1 of 1 · 9 matching rows.

levocetirizine dihydrochloride
levocetirizine
CELLULOSE, MICROCRYSTALLINE
LACTOSE MONOHYDRATE
SILICON DIOXIDE
MAGNESIUM STEARATE
HYPROMELLOSES
TITANIUM DIOXIDE
Polyethylene Glycol, Unspecified

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
63868-473	63868-473-35
43598-735

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 8 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
levocetirizine dihydrochloride	SOD6A38AGA	ACTIB
CELLULOSE, MICROCRYSTALLINE	OP1R32D61U	IACT
LACTOSE MONOHYDRATE	EWQ57Q8I5X	IACT
SILICON DIOXIDE	ETJ7Z6XBU4	IACT
MAGNESIUM STEARATE	70097M6I30	IACT
HYPROMELLOSES	3NXW29V3WO	IACT
TITANIUM DIOXIDE	15FIX9V2JP	IACT
Polyethylene Glycol, Unspecified	3WJQ0SDW1A	IACT

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.

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A210375-001	LEVOCETIRIZINE DIHYDROCHLORIDE	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL			2018-01-19

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.

Product history page 1 of 2 · 43 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A210375-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	2018-01-19	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A210375-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	2018-01-19	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A210375-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	2018-01-19	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210375-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	2018-01-19	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A210375-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	2018-01-19	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210375-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	2018-01-19	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210375-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	2018-01-19	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210375-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	2018-01-19	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210375-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	2018-01-19	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210375-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	2018-01-19	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210375-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	2018-01-19	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A210375-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	2018-01-19	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A210375-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	2018-01-19	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A210375-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	2018-01-19	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A210375-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	2018-01-19	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A210375-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	2018-01-19	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A210375-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	2018-01-19	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A210375-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	2018-01-19	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A210375-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	2018-01-19	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A210375-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	2018-01-19	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A210375-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	2018-01-19	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A210375-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	2018-01-19	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A210375-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	2018-01-19	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A210375-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	2018-01-19	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A210375-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	2018-01-19	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A210375-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	2018-01-19	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A210375-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	2018-01-19	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A210375-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	2018-01-19	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A210375-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	2018-01-19	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A210375-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	2018-01-19	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A210375-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	2018-01-19	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A210375-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	2018-01-19	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A210375-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	2018-01-19	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A210375-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	2018-01-19	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A210375-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	2018-01-19	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A210375-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	2018-01-19	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A210375-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	2018-01-19	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A210375-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	2018-01-19	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A210375-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	2018-01-19	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A210375-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	2018-01-19	`f41ea6bd6efb…`

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.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
levocetirizine dihydrochloride	LEVOCETIRIZINE DIHYDROCHLORIDE	Dr. Reddy's Laboratories Inc.	1f722b84-08de-7e6a-41ac-2c9d9bb9fb43	2026-06-04	Warnings	Exact identifier ndc (product): 43598-735
levocetirizine dihydrochloride	LEVOCETIRIZINE DIHYDROCHLORIDE	Chain Drug Marketing Association INC	61fb8bef-d868-adee-3237-d3268d603ba6	2025-12-10	Warnings	Exact identifier ndc (package): 63868-473-35 ndc (product): 63868-473 ndc11 (package): 63868047335 spl id: 62bd5a02-2f4d-697f-856c-7516352417c1 spl set id: 61fb8bef-d868-adee-3237-d3268d603ba6

Reported adverse events (FAERS/openFDA)#

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