DRUG FACTS

Manufacturer: Strides Pharma, Inc. | Onesource Softgels Pte. Ltd. | Strides Pharma Science Limited
Effective date: 2026-08-24
Label type: HUMAN OTC DRUG LABEL
Version: 4
Source: daily-update
Hydrated at: 2026-08-26 01:02:09

Label at a glance#

Productcetirizine hydrochloride

Active ingredientCETIRIZINE HYDROCHLORIDE

Label structure10 sections

Indications and 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

adults and children 6 years and over One 10 mg capsule once daily; do not take more than one 10 mg capsule 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

Contacts and useful links#

PhonePoison Help1-800-222-1222

PhoneLabel contact1-877-244-9825

Label contents#

Full prescribing information#

Active ingredient (in each capsule)

OTC - ACTIVE INGREDIENT SECTION

Cetirizine HCl USP, 10 mg

Purpose

OTC - PURPOSE SECTION

Antihistamine

Uses

INDICATIONS & USAGE SECTION

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

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

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

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

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
in rare cases, you may experience itching after stopping cetirizine. Consult your healthcare provider if this happens.

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

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).

Directions

DOSAGE & ADMINISTRATION SECTION

adults and children 6 years and over	One 10 mg capsule once daily; do not take more than one 10 mg capsule 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 Information

OTHER SAFETY INFORMATION

store at 20°-25°C (68°-77°F)
avoid high humidity and excessive heat above 40°C (104°F)
protect from light
Do not use if Tamper-Evident seal under cap imprinted with "Sealed for your Protection" is broken or missing.

Inactive ingredients

INACTIVE INGREDIENT SECTION

gelatin, medium chain triglyceride, polyethylene glycol 400, printing ink white (isopropyl alcohol, propylene glycol, shellac resins, sodium lauryl sulphate, titanium dioxide) purified water, sodium hydroxide, sorbitol-sorbitan solution.

OTC - QUESTIONS SECTION

Questions or comments?

call 1-877-244-9825

Distributed by:
Strides Pharma, Inc
Bridgewater, NJ 08807.

Revised: 08/2026

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Cetirizine HCL
Capsules, 10mg
Antihistamine Allergy
-Original Prescription Strength
-24 Hour Relief of
Runny nose
Sneezing
Itchy, watery eyes
Itching of the nose or throat
-INDOOR & OUTDOOR ALLERGIES

12 Liquid Filled Capsules -Carton Label

carton-12s

12 Liquid Filled Capsules -Container Label

container-12s-part-1-top

container-12s-part-1-back

container-12s-part-2-top

container-12s-part-2-back

container-12s-base-label

25 Liquid Filled Capsules -Carton Label

carton-25s

25 Liquid Filled Capsules -Container Label

container-25s-part-1-top

container-25s-part-1-back

container-25s-part-2-top

container-25s-part-2-back

container-25s-base-label

40 Liquid Filled Capsules -Carton Label

carton-40s

40 Liquid Filled Capsules -Container Label

container-40s-top

container-40s-base-label

7000 Liquid Filled Capsules -Carton Label (Transit Pack)

carton-7000s-bulk-label

Product Linked Resources#

Resource, Code type, Value table
Resource	Code type	Value	Equivalent identifiers	Source image
Barcode	EAN-13	0359556894121	GTIN-13: 0359556894121 EAN-13: 0359556894121 GTIN-12: 359556894121 UPC-A: 359556894121 GTIN storage (14 digits): 00359556894121	container-40s-top.jpg
Barcode	EAN-13	0359556894770	GTIN-13: 0359556894770 EAN-13: 0359556894770 GTIN-12: 359556894770 UPC-A: 359556894770 GTIN storage (14 digits): 00359556894770	container-12s-part-1-top.jpg

Products#

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

DailyMed product names page 1 of 1 · 14 matching rows.

cetirizine hydrochloride
CETIRIZINE
GELATIN
ISOPROPYL ALCOHOL
MEDIUM-CHAIN TRIGLYCERIDES
POLYETHYLENE GLYCOL 400
PROPYLENE GLYCOL
SHELLAC
SODIUM HYDROXIDE
SODIUM LAURYL SULFATE
SORBITAN
SORBITOL
TITANIUM DIOXIDE
WATER

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
59556-894	59556-894-12, 59556-894-77, 59556-894-79, 59556-894-78

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 13 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
CETIRIZINE HYDROCHLORIDE	64O047KTOA	ACTIB
GELATIN	2G86QN327L	IACT
ISOPROPYL ALCOHOL	ND2M416302	IACT
MEDIUM-CHAIN TRIGLYCERIDES	C9H2L21V7U	IACT
POLYETHYLENE GLYCOL 400	B697894SGQ	IACT
PROPYLENE GLYCOL	6DC9Q167V3	IACT
SHELLAC	46N107B71O	IACT
SODIUM HYDROXIDE	55X04QC32I	IACT
SODIUM LAURYL SULFATE	368GB5141J	IACT
SORBITAN	6O92ICV9RU	IACT
SORBITOL	506T60A25R	IACT
TITANIUM DIOXIDE	15FIX9V2JP	IACT
WATER	059QF0KO0R	IACT

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
Version	Effective date	Source	Hydrated
2	2023-01-10	legacy-cache	2026-08-01 21:40:57

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
A205291-001	CETIRIZINE HYDROCHLORIDE ALLERGY	CETIRIZINE HYDROCHLORIDE	10MG	CAPSULE / ORAL			2017-07-21

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	A205291-001	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	CAPSULE / ORAL	2017-07-21	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A205291-001	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	CAPSULE / ORAL	2017-07-21	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A205291-001	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	CAPSULE / ORAL	2017-07-21	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205291-001	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	CAPSULE / ORAL	2017-07-21	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A205291-001	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	CAPSULE / ORAL	2017-07-21	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205291-001	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	CAPSULE / ORAL	2017-07-21	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205291-001	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	CAPSULE / ORAL	2017-07-21	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205291-001	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	CAPSULE / ORAL	2017-07-21	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205291-001	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	CAPSULE / ORAL	2017-07-21	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205291-001	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	CAPSULE / ORAL	2017-07-21	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A205291-001	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	CAPSULE / ORAL	2017-07-21	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A205291-001	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	CAPSULE / ORAL	2017-07-21	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A205291-001	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	CAPSULE / ORAL	2017-07-21	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A205291-001	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	CAPSULE / ORAL	2017-07-21	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A205291-001	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	CAPSULE / ORAL	2017-07-21	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A205291-001	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	CAPSULE / ORAL	2017-07-21	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A205291-001	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	CAPSULE / ORAL	2017-07-21	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A205291-001	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	CAPSULE / ORAL	2017-07-21	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A205291-001	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	CAPSULE / ORAL	2017-07-21	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A205291-001	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	CAPSULE / ORAL	2017-07-21	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A205291-001	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	CAPSULE / ORAL	2017-07-21	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A205291-001	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	CAPSULE / ORAL	2017-07-21	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A205291-001	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	CAPSULE / ORAL	2017-07-21	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A205291-001	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	CAPSULE / ORAL	2017-07-21	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A205291-001	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	CAPSULE / ORAL	2017-07-21	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A205291-001	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	CAPSULE / ORAL	2017-07-21	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A205291-001	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	CAPSULE / ORAL	2017-07-21	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A205291-001	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	CAPSULE / ORAL	2017-07-21	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A205291-001	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	CAPSULE / ORAL	2017-07-21	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A205291-001	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	CAPSULE / ORAL	2017-07-21	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A205291-001	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	CAPSULE / ORAL	2017-07-21	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A205291-001	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	CAPSULE / ORAL	2017-07-21	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A205291-001	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	CAPSULE / ORAL	2017-07-21	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A205291-001	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	CAPSULE / ORAL	2017-07-21	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A205291-001	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	CAPSULE / ORAL	2017-07-21	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A205291-001	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	CAPSULE / ORAL	2017-07-21	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A205291-001	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	CAPSULE / ORAL	2017-07-21	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A205291-001	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	CAPSULE / ORAL	2017-07-21	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A205291-001	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	CAPSULE / ORAL	2017-07-21	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A205291-001	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	CAPSULE / ORAL	2017-07-21	`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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
cetirizine hydrochloride	CETIRIZINE HYDROCHLORIDE	Strides Pharma, Inc.	29c433eb-6cf4-4bcf-8b2a-0398fb4cdcba	2026-08-24	Warnings	Exact identifier ndc (package): 59556-894-77 ndc (package): 59556-894-78 ndc (package): 59556-894-12 ndc (package): 59556-894-79 ndc (product): 59556-894 ndc11 (package): 59556089479 ndc11 (package): 59556089477 ndc11 (package): 59556089412 ndc11 (package): 59556089478 spl id: 59c7dbe5-bf71-fd55-e063-6294a90a7635 spl set id: 29c433eb-6cf4-4bcf-8b2a-0398fb4cdcba

Reported adverse events (FAERS/openFDA)#

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