Cetirizine Hydrochloride Tablets,10 mg

Manufacturer: TIME CAP LABORATORIES, INC. | MARKSANS PHARMA LIMITED
Effective date: 2024-03-06
Label type: HUMAN OTC DRUG LABEL
Version: 5
Source: full-release
Hydrated at: 2026-06-01 00:09:27

Label at a glance#

ProductCetirizine Hydrochloride Tablets,10 mg

Active ingredientCETIRIZINE HYDROCHLORIDE

Label structure9 sections

Contacts and useful links#

PhonePoison Help1-800-222-1222

PhoneLabel contact1-877-290-4008

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active ingredient (in each tablet)
Cetirizine HCl 10 mg

OTC - PURPOSE SECTION

Purpose
Antihistamine

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 SECTION

Warnings

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.

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.

OTC - ASK DOCTOR/PHARMACIST SECTION

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

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 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 right away (1-800-222-1222).

DOSAGE & ADMINISTRATION SECTION

Directions

adults and children 6 years 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 liver or kidney disease	ask a doctor

OTHER SAFETY INFORMATION

Other information

• store between 20° to 25°C (68° to 77°F).

INACTIVE INGREDIENT SECTION

Inactive ingredients corn starch, hypromellose, lactose monohydrate, magnesium stearate, polyethylene glycol, povidone, titanium dioxide

OTC - QUESTIONS SECTION

Questions or comments?

Call 1-877-290-4008

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

cetirizine-hcl-200s-labelcetirizine-hcl-100s-label692R-timely-cetirizine10mg-500ct-label692R-Timely-Cetirizine-bottle-label-365s

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
1014678	cetirizine HCl 10 MG Oral Tablet	PSN	5
1014678	cetirizine hydrochloride 10 MG Oral Tablet	SCD	5
1014678	cetirizine HCl 10 MG Oral Tablet	SY	5

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	SPL version
49483-692-01	Cetirizine Hydrochloride Tablets,10 mg	100 in 1 BOTTLE	TABLET	100	5
49483-692-20	Cetirizine Hydrochloride Tablets,10 mg	200 in 1 BOTTLE	TABLET	200	5
49483-692-50	Cetirizine Hydrochloride Tablets,10 mg	500 in 1 BOTTLE	TABLET	500	5
49483-692-65	Cetirizine Hydrochloride Tablets,10 mg	365 in 1 BOTTLE	TABLET	365	5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
49483-692	CETIRIZINE HYDROCHLORIDE TABLETS,10 MG (CETIRIZINE HYDROCHLORIDE) TABLET [TIME CAP LABORATORIES, INC.]	5	Current NDC, Legacy NDC, 4 package rows	20240307_d78223ba-80d5-47f8-e053-2a95a90aebdb.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
49483-692-50	EA - Each	49483-692	aa32685a-0f2a-4373-875f-ad9cb8786c8b	1	2022-08-04

Products#

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

DailyMed product names page 1 of 1 · 10 matching rows.

Cetirizine Hydrochloride Tablets,10 mg
Cetirizine Hydrochloride
CETIRIZINE
TITANIUM DIOXIDE
LACTOSE MONOHYDRATE
STARCH, CORN
POVIDONE K30
MAGNESIUM STEARATE
HYPROMELLOSES
POLYETHYLENE GLYCOL, UNSPECIFIED

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
49483-692	49483-692-65, 49483-692-50, 49483-692-01, 49483-692-20

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
CETIRIZINE HYDROCHLORIDE	64O047KTOA	ACTIB
TITANIUM DIOXIDE	15FIX9V2JP	IACT
LACTOSE MONOHYDRATE	EWQ57Q8I5X	IACT
STARCH, CORN	O8232NY3SJ	IACT
POVIDONE K30	U725QWY32X	IACT
MAGNESIUM STEARATE	70097M6I30	IACT
HYPROMELLOSES	3NXW29V3WO	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 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	Approval date
A078933-001	CETIRIZINE HYDROCHLORIDE ALLERGY	CETIRIZINE HYDROCHLORIDE	5MG	TABLET / ORAL	2010-06-15
A078933-002	CETIRIZINE HYDROCHLORIDE ALLERGY	CETIRIZINE HYDROCHLORIDE	10MG	TABLET / ORAL	2010-06-15
A078933-003	CETIRIZINE HYDROCHLORIDE HIVES	CETIRIZINE HYDROCHLORIDE	5MG	TABLET / ORAL	2010-06-15
A078933-004	CETIRIZINE HYDROCHLORIDE HIVES	CETIRIZINE HYDROCHLORIDE	10MG	TABLET / ORAL	2010-06-15

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	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A078933-001	CETIRIZINE HYDROCHLORIDE ALLERGY	5MG	TABLET / ORAL	2010-06-15	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A078933-002	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	TABLET / ORAL	2010-06-15	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A078933-003	CETIRIZINE HYDROCHLORIDE HIVES	5MG	TABLET / ORAL	2010-06-15	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A078933-004	CETIRIZINE HYDROCHLORIDE HIVES	10MG	TABLET / ORAL	2010-06-15	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A078933-001	CETIRIZINE HYDROCHLORIDE ALLERGY	5MG	TABLET / ORAL	2010-06-15	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078933-002	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	TABLET / ORAL	2010-06-15	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078933-003	CETIRIZINE HYDROCHLORIDE HIVES	5MG	TABLET / ORAL	2010-06-15	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078933-004	CETIRIZINE HYDROCHLORIDE HIVES	10MG	TABLET / ORAL	2010-06-15	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A078933-001	CETIRIZINE HYDROCHLORIDE ALLERGY	5MG	TABLET / ORAL	2010-06-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078933-002	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	TABLET / ORAL	2010-06-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078933-003	CETIRIZINE HYDROCHLORIDE HIVES	5MG	TABLET / ORAL	2010-06-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078933-004	CETIRIZINE HYDROCHLORIDE HIVES	10MG	TABLET / ORAL	2010-06-15	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078933-001	CETIRIZINE HYDROCHLORIDE ALLERGY	5MG	TABLET / ORAL	2010-06-15	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078933-002	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	TABLET / ORAL	2010-06-15	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078933-003	CETIRIZINE HYDROCHLORIDE HIVES	5MG	TABLET / ORAL	2010-06-15	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078933-004	CETIRIZINE HYDROCHLORIDE HIVES	10MG	TABLET / ORAL	2010-06-15	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078933-001	CETIRIZINE HYDROCHLORIDE ALLERGY	5MG	TABLET / ORAL	2010-06-15	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078933-002	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	TABLET / ORAL	2010-06-15	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078933-003	CETIRIZINE HYDROCHLORIDE HIVES	5MG	TABLET / ORAL	2010-06-15	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078933-004	CETIRIZINE HYDROCHLORIDE HIVES	10MG	TABLET / ORAL	2010-06-15	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078933-001	CETIRIZINE HYDROCHLORIDE ALLERGY	5MG	TABLET / ORAL	2010-06-15	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078933-002	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	TABLET / ORAL	2010-06-15	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078933-003	CETIRIZINE HYDROCHLORIDE HIVES	5MG	TABLET / ORAL	2010-06-15	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078933-004	CETIRIZINE HYDROCHLORIDE HIVES	10MG	TABLET / ORAL	2010-06-15	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078933-001	CETIRIZINE HYDROCHLORIDE ALLERGY	5MG	TABLET / ORAL	2010-06-15	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078933-002	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	TABLET / ORAL	2010-06-15	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078933-003	CETIRIZINE HYDROCHLORIDE HIVES	5MG	TABLET / ORAL	2010-06-15	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078933-004	CETIRIZINE HYDROCHLORIDE HIVES	10MG	TABLET / ORAL	2010-06-15	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078933-001	CETIRIZINE HYDROCHLORIDE ALLERGY	5MG	TABLET / ORAL	2010-06-15	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078933-002	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	TABLET / ORAL	2010-06-15	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078933-003	CETIRIZINE HYDROCHLORIDE HIVES	5MG	TABLET / ORAL	2010-06-15	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078933-004	CETIRIZINE HYDROCHLORIDE HIVES	10MG	TABLET / ORAL	2010-06-15	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078933-001	CETIRIZINE HYDROCHLORIDE ALLERGY	5MG	TABLET / ORAL	2010-06-15	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078933-002	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	TABLET / ORAL	2010-06-15	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078933-003	CETIRIZINE HYDROCHLORIDE HIVES	5MG	TABLET / ORAL	2010-06-15	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078933-004	CETIRIZINE HYDROCHLORIDE HIVES	10MG	TABLET / ORAL	2010-06-15	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078933-001	CETIRIZINE HYDROCHLORIDE ALLERGY	5MG	TABLET / ORAL	2010-06-15	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078933-002	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	TABLET / ORAL	2010-06-15	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078933-003	CETIRIZINE HYDROCHLORIDE HIVES	5MG	TABLET / ORAL	2010-06-15	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078933-004	CETIRIZINE HYDROCHLORIDE HIVES	10MG	TABLET / ORAL	2010-06-15	`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
Cetirizine Hydrochloride Tablets,10 mg	CETIRIZINE HYDROCHLORIDE	TIME CAP LABORATORIES, INC.	d78223ba-80d5-47f8-e053-2a95a90aebdb	2024-03-06	Warnings	Exact identifier ndc (package): 49483-692-01 ndc (package): 49483-692-65 ndc (package): 49483-692-20 ndc (package): 49483-692-50 ndc (product): 49483-692 ndc11 (package): 49483069220 ndc11 (package): 49483069265 ndc11 (package): 49483069250 ndc11 (package): 49483069201 spl id: 12f9d89b-5334-1339-e063-6394a90ad0e8 spl set id: d78223ba-80d5-47f8-e053-2a95a90aebdb

Reported adverse events (FAERS/openFDA)#

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