Dr. Simi Levocetirizine Dihydrochloride

Manufacturer: Farmacias De Similares TX LLC | Annora Pharma Private Limited
Effective date: 2026-04-06
Label type: HUMAN OTC DRUG LABEL
Version: 1
Source: full-release
Hydrated at: 2026-06-01 01:57:53

Label at a glance#

ProductLevocetirizine Dihydrochloride

Active ingredientLEVOCETIRIZINE DIHYDROCHLORIDE

Label structure10 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 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 ■ 1/2 tablet (2.5 mg) once daily in the evening may be appropriate for less severe symptoms children 6 to 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 h...

Contacts and useful links#

PhonePoison Help1-800-222-1222

PhoneLabel contact(855)-280-1079

Websitewww.drsimi.com

www.drsimi.com

Label contents#

Full prescribing information#

Drug Facts 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 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 ■ 1/2 tablet (2.5 mg) once daily in the evening may be appropriate for less severe symptoms
children 6 to 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

OTHER SAFETY INFORMATION

■ store between 20° and 25°C (68° and 77°F)
■ safety sealed: do not use if carton was opened or if individual blister unit is open or torn

Inactive ingredients

INACTIVE INGREDIENT SECTION

Colloidal silicone dioxide, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, titanium dioxide.

Questions or comments?

OTC - QUESTIONS SECTION

(855)-280-1079

Principal Display Panel

SPL UNCLASSIFIED SECTION

NDC: 85786-206-30

DR. SIMI

Allergy Relief

Levocetirizine Dihydrochloride
Tablets, USP 5 mg

Antihistamine

24 HOUR Relief of: • Sneezing • Runny Nose • Itchy Nose or Throat • Itchy, Watery Eyes

30 Tablets

Compare to XYZAL® 24 HR Active Ingredient*

*This product is not manufactured or distributed by Chattem, Inc. owner of the registered trademark XYZAL® Allergy 24HR.

Read directions and warnings before use.

Keep this carton.

It has important information.

Distributed by:
FARMACIAS DE SIMILARES TX LLC
800 Brazos St Ste 260, Austin, TX, 78701, USA
customerservice@drsimi.com
www.drsimi.com

Carton labeling

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Carton labeling

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
855172	levocetirizine dihydrochloride 5 MG Oral Tablet	PSN	1
855172	levocetirizine dihydrochloride 5 MG Oral Tablet	SCD	1
855172	levocetirizine dihydrochloride 5 MG 24 HR Oral Tablet	SY	1

DailyMed Pharmacologic Classes#

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

Product Linked Resources#

Resource, Code type, Value table
Resource	Code type	Value	Equivalent identifiers	Source image
Barcode	EAN-13	0199961000331	GTIN-13: 0199961000331 EAN-13: 0199961000331 GTIN-12: 199961000331 UPC-A: 199961000331 GTIN storage (14 digits): 00199961000331	Levocetirizine Dihydrochloride - PDP.jpg

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
85786-206-30	Levocetirizine Dihydrochloride	15 in 1 BLISTER PACK	TABLET, FILM COATED	15		1
85786-206-30	Levocetirizine Dihydrochloride	2 in 1 CARTON	TABLET, FILM COATED	2		1

Products#

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

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

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

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
85786-206	85786-206-30

Ingredients#

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

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

Name, UNII, Kind table
Name	UNII	Kind
SILICON DIOXIDE	ETJ7Z6XBU4	IACT
POLYETHYLENE GLYCOL 400	B697894SGQ	IACT
LEVOCETIRIZINE DIHYDROCHLORIDE	SOD6A38AGA	ACTIB
LACTOSE MONOHYDRATE	EWQ57Q8I5X	IACT
HYPROMELLOSE 2910 (3 MPA.S)	0VUT3PMY82	IACT
MAGNESIUM STEARATE	70097M6I30	IACT
TITANIUM DIOXIDE	15FIX9V2JP	IACT
HYPROMELLOSE 2910 (6 MPA.S)	0WZ8WG20P6	IACT
MICROCRYSTALLINE CELLULOSE	OP1R32D61U	IACT
POLYSORBATE 80	6OZP39ZG8H	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
A213513-001	LEVOCETIRIZINE DIHYDROCHLORIDE	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL			2020-04-29

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.

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	A213513-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	2020-04-29	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A213513-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	2020-04-29	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A213513-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	2020-04-29	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213513-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	2020-04-29	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A213513-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	2020-04-29	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213513-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	2020-04-29	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213513-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	2020-04-29	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213513-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	2020-04-29	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213513-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	2020-04-29	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213513-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	2020-04-29	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213513-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	2020-04-29	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A213513-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	2020-04-29	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A213513-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	2020-04-29	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A213513-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	2020-04-29	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A213513-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	2020-04-29	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A213513-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	2020-04-29	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A213513-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	2020-04-29	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A213513-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	2020-04-29	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A213513-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	2020-04-29	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A213513-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	2020-04-29	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A213513-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	2020-04-29	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A213513-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	2020-04-29	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A213513-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	2020-04-29	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A213513-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	2020-04-29	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A213513-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	2020-04-29	`c0c555d07b60…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A213513-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	2020-04-29	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A213513-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	2020-04-29	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A213513-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	2020-04-29	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A213513-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	2020-04-29	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A213513-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	2020-04-29	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A213513-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	2020-04-29	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A213513-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	2020-04-29	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A213513-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	2020-04-29	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A213513-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	2020-04-29	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A213513-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	2020-04-29	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A213513-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	2020-04-29	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A213513-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	2020-04-29	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A213513-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	2020-04-29	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A213513-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	2020-04-29	`a50c72e98297…`

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
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Levocetirizine Dihydrochloride	LEVOCETIRIZINE DIHYDROCHLORIDE	Farmacias De Similares TX LLC	4ed17484-5609-d993-e063-6294a90a82a2	2026-04-06	Warnings	Exact identifier ndc (package): 85786-206-30 ndc (product): 85786-206 ndc11 (package): 85786020630 spl id: 4ed17484-560a-d993-e063-6294a90a82a2 spl set id: 4ed17484-5609-d993-e063-6294a90a82a2

Reported adverse events (FAERS/openFDA)#

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