Zyrtec Allergy, Lil Drug Store

Manufacturer: Lil' Drug Store Products, Inc.
Effective date: 2024-06-21
Label type: HUMAN OTC DRUG LABEL
Version: 1
Source: full-release
Hydrated at: 2026-06-01 00:15:06

Label at a glance#

ProductZyrtec Allergy, Lil Drug Store

Active ingredientCETIRIZINE HYDROCHLORIDE

Label structure9 sections

Indications and uses

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

Dosage and administration

Directions adults and children 6 years of age and over one 10 mg tablet once daily; do not take more than one 10 mg tablet in 24 hours. A 5 mg product may be appropriate for less severe symptoms. adults 65 years and over ask a doctor children under 6 years of age ask a doctor consumers with kidney disease ask a doctor

Contacts and useful links#

PhonePoison Help1-800-222-1222

PhoneLabel contact1-800-343-7805

PhoneLabel contact215-273-8755

Label contents#

Full prescribing information#

Drug Facts

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Active ingredient (in each tablet)

Cetirizine HCl 10 mg

Purpose

OTC - PURPOSE SECTION

Purpose

Antihistamine

Uses

INDICATIONS & USAGE SECTION

Uses
temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:

runny nose
sneezing
itchy, watery eyes
itching of the nose or throat

Warnings

WARNINGS SECTION

Warnings

Do not use

OTC - DO NOT USE SECTION

Do not use if you have ever had an allergic reaction to this product or any of its ingredients or to an antihistamine containing hydroxyzine.

Ask a doctor

OTC - ASK DOCTOR SECTION

Ask a doctor before use if you have liver or kidney disease. Your doctor should determine if you need a different dose.

Ask a doctor or pharmacist

OTC - ASK DOCTOR/PHARMACIST SECTION

Ask a doctor or pharmacist before use if you are taking tranquilizers or sedatives.

When using this product

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

Stop use and ask a doctor

OTC - STOP USE SECTION

Stop use and ask a doctor if an allergic reaction to this product occurs. Seek medical help right away.

If pregnant or breast-feeding

OTC - PREGNANCY OR BREAST FEEDING SECTION

If pregnant or breast-feeding:

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

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

Directions

DOSAGE & ADMINISTRATION SECTION

Directions

adults and children 6 years of age and over	one 10 mg tablet once daily; do not take more than one 10 mg tablet in 24 hours. A 5 mg product may be appropriate for less severe symptoms.
adults 65 years and over	ask a doctor
children under 6 years of age	ask a doctor
consumers with kidney disease	ask a doctor

Other information

SPL UNCLASSIFIED SECTION

Other information

store between 20° to 25°C (68° to 77°F)
do not use if pouch is torn or damaged
meets USP Dissolution Test 2

Inactive ingredients

INACTIVE INGREDIENT SECTION

Inactive ingredients

colloidal silicon dioxide, croscarmellose sodium, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, titanium dioxide

Questions?

OTC - QUESTIONS SECTION

Questions? call 1-800-343-7805 (toll-free) or 215-273-8755 (collect)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Original Prescription Strength

Zyrtec Allergy

Cetirizine HCl tablets

10 mg / antihistamine

Indoor & Outdoor Allergies

hour

Relief of

Sneezing
Runny Nose
Itchy, Watery Eyes
Itchy Throat or Nose

[tablet image]

TABLET 10 mg

[Lil' Drug Store logo]

PDP/Package

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
1014678	cetirizine HCl 10 MG Oral Tablet	PSN	1
1020026	ZyrTEC 10 MG Oral Tablet	PSN	1
1020026	cetirizine hydrochloride 10 MG Oral Tablet [Zyrtec]	SBD	1
1014678	cetirizine hydrochloride 10 MG Oral Tablet	SCD	1
1014678	cetirizine HCl 10 MG Oral Tablet	SY	1
1020026	Zyrtec (cetirizine dihydrochloride 10 MG) Oral Tablet	SY	1
1020026	Zyrtec 10 MG Oral Tablet	SY	1

DailyMed Pharmacologic Classes#

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

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
c505bb17-4ff9-45f9-ac2d-bb9c8c9d35be	Product name	1	20200304
a255659f-db40-429d-8c07-5f173f330d9c	Product name	1	20190402

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
66715-9811-1	Zyrtec Allergy, Lil Drug Store	1 in 1 CARTON	TABLET, FILM COATED	1		1
66715-9811-1	Zyrtec Allergy, Lil Drug Store	1 in 1 POUCH	TABLET, FILM COATED	1		1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
66715-9811	ZYRTEC ALLERGY, LIL DRUG STORE (CETIRIZINE HYDROCHLORIDE TABLET, FILM COATED) TABLET, FILM COATED [LIL' DRUG STORE PRODUCTS, INC.]	1	Current NDC, 2 package rows	20240712_1b6c945f-591f-8869-e063-6294a90ad397.zip

Products#

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

DailyMed product names page 1 of 1 · 12 matching rows.

Zyrtec Allergy, Lil Drug Store
Cetirizine Hydrochloride tablet, film coated
CETIRIZINE HYDROCHLORIDE
CETIRIZINE
CROSCARMELLOSE SODIUM
HYPROMELLOSE, UNSPECIFIED
MAGNESIUM STEARATE
SILICON DIOXIDE
POLYETHYLENE GLYCOL, UNSPECIFIED
LACTOSE MONOHYDRATE
MICROCRYSTALLINE CELLULOSE
TITANIUM DIOXIDE

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
66715-9811	66715-9811-1

Ingredients#

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

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

Name, UNII, Kind table
Name	UNII	Kind
CETIRIZINE HYDROCHLORIDE	64O047KTOA	ACTIB
CROSCARMELLOSE SODIUM	M28OL1HH48	IACT
HYPROMELLOSE, UNSPECIFIED	3NXW29V3WO	IACT
MAGNESIUM STEARATE	70097M6I30	IACT
SILICON DIOXIDE	ETJ7Z6XBU4	IACT
POLYETHYLENE GLYCOL, UNSPECIFIED	3WJQ0SDW1A	IACT
LACTOSE MONOHYDRATE	EWQ57Q8I5X	IACT
MICROCRYSTALLINE CELLULOSE	OP1R32D61U	IACT
TITANIUM DIOXIDE	15FIX9V2JP	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 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	RLD / RS	Approval date
N019835-003	ZYRTEC ALLERGY	CETIRIZINE HYDROCHLORIDE	5MG	TABLET / ORAL	RLD	2007-11-16
N019835-004	ZYRTEC ALLERGY	CETIRIZINE HYDROCHLORIDE	10MG	TABLET / ORAL	RLD, RS	2007-11-16
N019835-005	ZYRTEC HIVES	CETIRIZINE HYDROCHLORIDE	5MG	TABLET / ORAL	RLD	2007-11-16
N019835-006	ZYRTEC HIVES	CETIRIZINE HYDROCHLORIDE	10MG	TABLET / ORAL	RLD	2007-11-16

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 5 · 172 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	N019835-003	ZYRTEC ALLERGY	5MG	TABLET / ORAL	RLD	2007-11-16	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N019835-004	ZYRTEC ALLERGY	10MG	TABLET / ORAL	RLD, RS	2007-11-16	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N019835-005	ZYRTEC HIVES	5MG	TABLET / ORAL	RLD	2007-11-16	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N019835-006	ZYRTEC HIVES	10MG	TABLET / ORAL	RLD	2007-11-16	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N019835-003	ZYRTEC ALLERGY	5MG	TABLET / ORAL	RLD	2007-11-16	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N019835-004	ZYRTEC ALLERGY	10MG	TABLET / ORAL	RLD, RS	2007-11-16	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N019835-005	ZYRTEC HIVES	5MG	TABLET / ORAL	RLD	2007-11-16	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N019835-006	ZYRTEC HIVES	10MG	TABLET / ORAL	RLD	2007-11-16	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N019835-003	ZYRTEC ALLERGY	5MG	TABLET / ORAL	RLD	2007-11-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N019835-004	ZYRTEC ALLERGY	10MG	TABLET / ORAL	RLD, RS	2007-11-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N019835-005	ZYRTEC HIVES	5MG	TABLET / ORAL	RLD	2007-11-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N019835-006	ZYRTEC HIVES	10MG	TABLET / ORAL	RLD	2007-11-16	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N019835-003	ZYRTEC ALLERGY	5MG	TABLET / ORAL	RLD	2007-11-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N019835-004	ZYRTEC ALLERGY	10MG	TABLET / ORAL	RLD, RS	2007-11-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N019835-005	ZYRTEC HIVES	5MG	TABLET / ORAL	RLD	2007-11-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N019835-006	ZYRTEC HIVES	10MG	TABLET / ORAL	RLD	2007-11-16	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N019835-003	ZYRTEC ALLERGY	5MG	TABLET / ORAL	RLD	2007-11-16	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N019835-004	ZYRTEC ALLERGY	10MG	TABLET / ORAL	RLD, RS	2007-11-16	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N019835-005	ZYRTEC HIVES	5MG	TABLET / ORAL	RLD	2007-11-16	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N019835-006	ZYRTEC HIVES	10MG	TABLET / ORAL	RLD	2007-11-16	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N019835-003	ZYRTEC ALLERGY	5MG	TABLET / ORAL	RLD	2007-11-16	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N019835-004	ZYRTEC ALLERGY	10MG	TABLET / ORAL	RLD, RS	2007-11-16	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N019835-005	ZYRTEC HIVES	5MG	TABLET / ORAL	RLD	2007-11-16	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N019835-006	ZYRTEC HIVES	10MG	TABLET / ORAL	RLD	2007-11-16	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N019835-003	ZYRTEC ALLERGY	5MG	TABLET / ORAL	RLD	2007-11-16	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N019835-004	ZYRTEC ALLERGY	10MG	TABLET / ORAL	RLD, RS	2007-11-16	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N019835-005	ZYRTEC HIVES	5MG	TABLET / ORAL	RLD	2007-11-16	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N019835-006	ZYRTEC HIVES	10MG	TABLET / ORAL	RLD	2007-11-16	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N019835-003	ZYRTEC ALLERGY	5MG	TABLET / ORAL	RLD	2007-11-16	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N019835-004	ZYRTEC ALLERGY	10MG	TABLET / ORAL	RLD, RS	2007-11-16	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N019835-005	ZYRTEC HIVES	5MG	TABLET / ORAL	RLD	2007-11-16	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N019835-006	ZYRTEC HIVES	10MG	TABLET / ORAL	RLD	2007-11-16	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N019835-003	ZYRTEC ALLERGY	5MG	TABLET / ORAL	RLD	2007-11-16	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N019835-004	ZYRTEC ALLERGY	10MG	TABLET / ORAL	RLD, RS	2007-11-16	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N019835-005	ZYRTEC HIVES RELIEF	5MG	TABLET / ORAL	RLD	2007-11-16	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N019835-006	ZYRTEC HIVES RELIEF	10MG	TABLET / ORAL	RLD	2007-11-16	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N019835-003	ZYRTEC ALLERGY	5MG	TABLET / ORAL	RLD	2007-11-16	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N019835-004	ZYRTEC ALLERGY	10MG	TABLET / ORAL	RLD, RS	2007-11-16	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N019835-005	ZYRTEC HIVES RELIEF	5MG	TABLET / ORAL	RLD	2007-11-16	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N019835-006	ZYRTEC HIVES RELIEF	10MG	TABLET / ORAL	RLD	2007-11-16	`5bbf6a4d5a75…`

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
Zyrtec Allergy, Lil Drug Store	CETIRIZINE HYDROCHLORIDE TABLET, FILM COATED	Lil' Drug Store Products, Inc.	1b6c945f-591f-8869-e063-6294a90ad397	2024-06-21	Warnings	Exact identifier ndc (package): 66715-9811-1 ndc (product): 66715-9811 ndc11 (package): 66715981101 spl id: 1b6c945f-5920-8869-e063-6294a90ad397 spl set id: 1b6c945f-591f-8869-e063-6294a90ad397

Reported adverse events (FAERS/openFDA)#

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