Curist Allergy Relief Tablet (levocetirizine 5 mg)

Manufacturer: Little Pharma, Inc.
Effective date: 2026-03-05
Label type: HUMAN OTC DRUG LABEL
Version: 5
Source: full-release
Hydrated at: 2026-06-01 01:49:14

Label at a glance#

ProductCurist Allergy Relief

Active ingredientLEVOCETIRIZINE DIHYDROCHLORIDE

Label structure11 sections

Storage and handling

Other information store between 20° and 25°C (68° and 77°F)

Contacts and useful links#

PhonePoison Help1-800-222-1222

PhoneLabel contact1-844-243-1241

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

Active ingredient (in each tablet)

Levocetirizine dihydrochloride USP 5 mg

OTC - PURPOSE SECTION

Purpose

Antihistamine

INDICATIONS & USAGE SECTION

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

WARNINGS SECTION

Warnings

OTC - DO NOT USE SECTION

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

OTC - ASK DOCTOR SECTION

Ask a doctor before use if you have ever had trouble urinating or emptying your bladder.

OTC - WHEN USING SECTION

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

OTC - STOP USE SECTION

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.

OTC - PREGNANCY OR BREAST FEEDING SECTION

If pregnant or breast-feeding,

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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

DOSAGE & ADMINISTRATION SECTION

Directions

adults 65 years and older	ask a doctor
adults and children 12-64 years	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	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	do not use
consumers with kidney disease	do not use

STORAGE AND HANDLING SECTION

Other information

store between 20° and 25°C (68° and 77°F)

INACTIVE INGREDIENT SECTION

Inactive ingredients

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

OTC - QUESTIONS SECTION

Questions?

Call 1-844-243-1241 or email hi@curistrelief.com

SPL UNCLASSIFIED SECTION

Distributed by:

Little Pharma, Inc. New York, NY 10023

Made in India

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

curist

Allergy Relief

Levocetirizine Dihydrochloride Tablets, USP 5 mg

Antihistamine

24 Hour Relief of Runny Nose; Sneezing; Itchy, Watery Eyes; Itchy Nose or Throat

180 Tablets

curistrelief.com

Tamper Evident: Do Not Use If Safety Seal Under Cap Is Broken Or Missing

levocetirizine 180ct

DailyMed RxNorm Mappings#

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

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	0372559021561	GTIN-13: 0372559021561 EAN-13: 0372559021561 GTIN-12: 372559021561 UPC-A: 372559021561 GTIN storage (14 digits): 00372559021561	Levocetirizine 180 ct Artwork NDC 72559-021-56 REV 021-56-02-L.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	SPL version
72559-021-05	Curist Allergy Relief	1 in 1 CARTON	TABLET	1	5
72559-021-05	Curist Allergy Relief	90 in 1 BOTTLE	TABLET	90	5
72559-021-56	Curist Allergy Relief	180 in 1 BOTTLE	TABLET	180	5

Products#

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

DailyMed product names page 1 of 1 · 13 matching rows.

Curist Allergy Relief
Levocetirizine dihydrochloride 5 mg
LEVOCETIRIZINE DIHYDROCHLORIDE
LEVOCETIRIZINE
TITANIUM DIOXIDE
HYPROMELLOSE 2910 (3 MPA.S)
POLYETHYLENE GLYCOL 400
POLYSORBATE 80
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
MICROCRYSTALLINE CELLULOSE
HYPROMELLOSE 2910 (6 MPA.S)
SILICON DIOXIDE

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
72559-021	72559-021-05, 72559-021-56

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
LEVOCETIRIZINE DIHYDROCHLORIDE	SOD6A38AGA	ACTIB
TITANIUM DIOXIDE	15FIX9V2JP	IACT
HYPROMELLOSE 2910 (3 MPA.S)	0VUT3PMY82	IACT
POLYETHYLENE GLYCOL 400	B697894SGQ	IACT
POLYSORBATE 80	6OZP39ZG8H	IACT
LACTOSE MONOHYDRATE	EWQ57Q8I5X	IACT
MAGNESIUM STEARATE	70097M6I30	IACT
MICROCRYSTALLINE CELLULOSE	OP1R32D61U	IACT
HYPROMELLOSE 2910 (6 MPA.S)	0WZ8WG20P6	IACT
SILICON DIOXIDE	ETJ7Z6XBU4	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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Curist Allergy Relief	LEVOCETIRIZINE DIHYDROCHLORIDE 5 MG	Little Pharma, Inc.	f2a2a5bc-2efa-c550-e053-2a95a90a55ff	2026-03-05	Warnings	Exact identifier ndc (package): 72559-021-05 ndc (package): 72559-021-56 ndc (product): 72559-021 ndc11 (package): 72559002105 ndc11 (package): 72559002156 spl id: 4c4b5fdc-122b-70cc-e063-6394a90a0b58 spl set id: f2a2a5bc-2efa-c550-e053-2a95a90a55ff
Curist Allergy Relief	LEVOCETIRIZINE DIHYDROCHLORIDE 5 MG	Little Pharma, Inc.	feabf140-e283-dcd5-e053-6394a90a2917	2025-04-16	Warnings	Exact identifier ndc (product): 72559-021

Reported adverse events (FAERS/openFDA)#

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