Cetirizine HCl
- Manufacturer
- Strategic Sourcing Services LLC | Glenmark Pharmaceuticals Limited
- Effective date
- 2025-04-04
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 3
- Source
- full-release
- Hydrated at
- 2026-06-01 00:58:35
Label at a glance#
Contacts and useful links#
Label contents#
Full prescribing information#
OTC - ACTIVE INGREDIENT SECTION
Cetirizine HCl 10 mg
OTC - PURPOSE SECTION
Antihistamine
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 SECTION
Do not use if you have ever had an allergic reaction to this product or any of its ingredients or an antihistamine containing hydroxyzine.
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 before use if you are taking 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
Stop use and ask a doctor if an allergic reaction to this product occurs. Seek medical help right away.
If pregnant or breastfeeding:
- If breastfeeding: not recommended
- if pregnant: ask a health professional before use.
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
Cetirizine Hydrochloride Tablets, USP 10 mg
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 information
- store between 20°C to 25°C (68°F to 77°F)
- do not use if imprinted foil inner seal on bottle is broken or missing.
- FDA approved organic impurities test procedure differs from USP
INACTIVE INGREDIENT SECTION
colloidal silicon dioxide, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, sodium starch glycolate, titanium dioxide.
OTHER SAFETY INFORMATION
Questions or comments?
Call 833-358-6431 Monday to Friday 9:00am to 7:00pm EST
Manufactured by:
Glenmark Pharmaceuticals Limited
Pithampur, Madhya Pradesh 454775, India
Distributed by:
McKesson Corp. via SSSL
Memphis, TN 38141
Product of India
April 2025
Package/Label Principal Display Panel
Package/Label Principal Display Panel
DailyMed RxNorm Mappings#
DailyMed Pharmacologic Classes#
| Class | Version | Type | Effective |
|---|---|---|---|
| CETIRIZINE Pharmacologic Class Indexing | 3 | Indexing - Pharmacologic Class | 20180813 |
DailyMed Product Concepts#
| 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 | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 70677-1279-1 | Cetirizine HCl | 14 in 1 BOTTLE | TABLET | 14 | 3 | |
| 70677-1279-1 | Cetirizine HCl | 1 in 1 CARTON | TABLET | 1 | 3 | |
| 70677-1279-2 | Cetirizine HCl | 30 in 1 BOTTLE | TABLET | 30 | 3 | |
| 70677-1279-2 | Cetirizine HCl | 1 in 1 CARTON | TABLET | 1 | 3 | |
| 70677-1279-3 | Cetirizine HCl | 1 in 1 CARTON | TABLET | 1 | 3 | |
| 70677-1279-3 | Cetirizine HCl | 60 in 1 BOTTLE | TABLET | 60 | 3 | |
| 70677-1279-4 | Cetirizine HCl | 1 in 1 CARTON | TABLET | 1 | 3 | |
| 70677-1279-4 | Cetirizine HCl | 90 in 1 BOTTLE | TABLET | 90 | 3 | |
| 70677-1279-5 | Cetirizine HCl | 300 in 1 BOTTLE | TABLET | 300 | 3 | |
| 70677-1279-5 | Cetirizine HCl | 1 in 1 CARTON | TABLET | 1 | 3 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 70677-1279 | CETIRIZINE HCL (CETIRIZINE) TABLET [STRATEGIC SOURCING SERVICES LLC] | 3 | Current NDC, 10 package rows | 20250406_65b37b00-8efc-4e04-ab97-a03e8af27d33.zip |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 70677-1279-1 | EA - Each | 70677-1279 | 63246e3e-43d7-4378-98dd-078c5443cc7d | 1 | 2025-05-14 |
| 70677-1279-2 | EA - Each | 70677-1279 | eb504316-ffda-49c2-8db3-b1e1855fe4b6 | 1 | 2025-05-14 |
| 70677-1279-3 | EA - Each | 70677-1279 | 2e39a72d-e107-4a01-b0ba-1bdc100a49b5 | 1 | 2025-05-14 |
| 70677-1279-4 | EA - Each | 70677-1279 | 853f8a6b-588b-4a74-8561-6519d1318273 | 1 | 2025-05-14 |
| 70677-1279-5 | EA - Each | 70677-1279 | 674b3c93-67e0-4d42-b057-8eaeefde5ad2 | 1 | 2025-05-14 |
Products#
Every source-derived product name is available through these pages.
- Cetirizine HCl
- Cetirizine
- CETIRIZINE HYDROCHLORIDE
- SILICON DIOXIDE
- HYPROMELLOSE, UNSPECIFIED
- LACTOSE MONOHYDRATE
- MAGNESIUM STEARATE
- MICROCRYSTALLINE CELLULOSE
- POLYETHYLENE GLYCOL, UNSPECIFIED
- POVIDONE K30
- SODIUM STARCH GLYCOLATE TYPE A
- TITANIUM DIOXIDE
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 70677-1279 | 70677-1279-2, 70677-1279-3, 70677-1279-4, 70677-1279-5, 70677-1279-1 |
Ingredients#
Every source-derived ingredient row is available through these pages.
Source Document#
Orange Book application contexts#
All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A078427-003 | CETIRIZINE HYDROCHLORIDE ALLERGY | CETIRIZINE HYDROCHLORIDE | 5MG | TABLET / ORAL | 2007-12-28 | ||
| A078427-004 | CETIRIZINE HYDROCHLORIDE ALLERGY | CETIRIZINE HYDROCHLORIDE | 10MG | TABLET / ORAL | 2007-12-28 |
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 | Trade name | Strength | Dosage form / route | Product TE source text | RLD / RS | Approval date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | A078427-003 | CETIRIZINE HYDROCHLORIDE ALLERGY | 5MG | TABLET / ORAL | 2007-12-28 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | A078427-004 | CETIRIZINE HYDROCHLORIDE ALLERGY | 10MG | TABLET / ORAL | 2007-12-28 | 84e616aacf4f… | ||
| 2026-08-18 06:07:40 | 2026-07 | A078427-003 | CETIRIZINE HYDROCHLORIDE ALLERGY | 5MG | TABLET / ORAL | 2007-12-28 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A078427-004 | CETIRIZINE HYDROCHLORIDE ALLERGY | 10MG | TABLET / ORAL | 2007-12-28 | caaa826d4ba7… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A078427-003 | CETIRIZINE HYDROCHLORIDE ALLERGY | 5MG | TABLET / ORAL | 2007-12-28 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A078427-004 | CETIRIZINE HYDROCHLORIDE ALLERGY | 10MG | TABLET / ORAL | 2007-12-28 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A078427-003 | CETIRIZINE HYDROCHLORIDE ALLERGY | 5MG | TABLET / ORAL | 2007-12-28 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A078427-004 | CETIRIZINE HYDROCHLORIDE ALLERGY | 10MG | TABLET / ORAL | 2007-12-28 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A078427-003 | CETIRIZINE HYDROCHLORIDE ALLERGY | 5MG | TABLET / ORAL | 2007-12-28 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A078427-004 | CETIRIZINE HYDROCHLORIDE ALLERGY | 10MG | TABLET / ORAL | 2007-12-28 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A078427-003 | CETIRIZINE HYDROCHLORIDE ALLERGY | 5MG | TABLET / ORAL | 2007-12-28 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A078427-004 | CETIRIZINE HYDROCHLORIDE ALLERGY | 10MG | TABLET / ORAL | 2007-12-28 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A078427-003 | CETIRIZINE HYDROCHLORIDE ALLERGY | 5MG | TABLET / ORAL | 2007-12-28 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A078427-004 | CETIRIZINE HYDROCHLORIDE ALLERGY | 10MG | TABLET / ORAL | 2007-12-28 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A078427-003 | CETIRIZINE HYDROCHLORIDE ALLERGY | 5MG | TABLET / ORAL | 2007-12-28 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A078427-004 | CETIRIZINE HYDROCHLORIDE ALLERGY | 10MG | TABLET / ORAL | 2007-12-28 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A078427-003 | CETIRIZINE HYDROCHLORIDE ALLERGY | 5MG | TABLET / ORAL | 2007-12-28 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A078427-004 | CETIRIZINE HYDROCHLORIDE ALLERGY | 10MG | TABLET / ORAL | 2007-12-28 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A078427-003 | CETIRIZINE HYDROCHLORIDE ALLERGY | 5MG | TABLET / ORAL | 2007-12-28 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A078427-004 | CETIRIZINE HYDROCHLORIDE ALLERGY | 10MG | TABLET / ORAL | 2007-12-28 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A078427-003 | CETIRIZINE HYDROCHLORIDE ALLERGY | 5MG | TABLET / ORAL | 2007-12-28 | d8e5a09893c0… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A078427-004 | CETIRIZINE HYDROCHLORIDE ALLERGY | 10MG | TABLET / ORAL | 2007-12-28 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A078427-003 | CETIRIZINE HYDROCHLORIDE ALLERGY | 5MG | TABLET / ORAL | 2007-12-28 | d06236e962d9… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A078427-004 | CETIRIZINE HYDROCHLORIDE ALLERGY | 10MG | TABLET / ORAL | 2007-12-28 | d06236e962d9… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A078427-003 | CETIRIZINE HYDROCHLORIDE ALLERGY | 5MG | TABLET / ORAL | 2007-12-28 | 79d66fd596c7… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A078427-004 | CETIRIZINE HYDROCHLORIDE ALLERGY | 10MG | TABLET / ORAL | 2007-12-28 | 79d66fd596c7… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A078427-003 | CETIRIZINE HYDROCHLORIDE ALLERGY | 5MG | TABLET / ORAL | 2007-12-28 | 301d65b070ca… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A078427-004 | CETIRIZINE HYDROCHLORIDE ALLERGY | 10MG | TABLET / ORAL | 2007-12-28 | 301d65b070ca… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A078427-003 | CETIRIZINE HYDROCHLORIDE ALLERGY | 5MG | TABLET / ORAL | 2007-12-28 | 1e350fbaab3a… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A078427-004 | CETIRIZINE HYDROCHLORIDE ALLERGY | 10MG | TABLET / ORAL | 2007-12-28 | 1e350fbaab3a… | ||
| 2024-05-31 18:47 UTC | 2024-05 | A078427-003 | CETIRIZINE HYDROCHLORIDE ALLERGY | 5MG | TABLET / ORAL | 2007-12-28 | 8072bd15b7f6… | ||
| 2024-05-31 18:47 UTC | 2024-05 | A078427-004 | CETIRIZINE HYDROCHLORIDE ALLERGY | 10MG | TABLET / ORAL | 2007-12-28 | 8072bd15b7f6… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A078427-003 | CETIRIZINE HYDROCHLORIDE ALLERGY | 5MG | TABLET / ORAL | 2007-12-28 | 5c6f7cd8ea54… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A078427-004 | CETIRIZINE HYDROCHLORIDE ALLERGY | 10MG | TABLET / ORAL | 2007-12-28 | 5c6f7cd8ea54… | ||
| 2022-04-08 23:34 UTC | 2022-04 | A078427-003 | CETIRIZINE HYDROCHLORIDE ALLERGY | 5MG | TABLET / ORAL | 2007-12-28 | 5d02ea3f76ae… | ||
| 2022-04-08 23:34 UTC | 2022-04 | A078427-004 | CETIRIZINE HYDROCHLORIDE ALLERGY | 10MG | TABLET / ORAL | 2007-12-28 | 5d02ea3f76ae… | ||
| 2022-04-04 05:41 UTC | 2022-04 | A078427-003 | CETIRIZINE HYDROCHLORIDE ALLERGY | 5MG | TABLET / ORAL | 2007-12-28 | 4b0b4de00fa7… | ||
| 2022-04-04 05:41 UTC | 2022-04 | A078427-004 | CETIRIZINE HYDROCHLORIDE ALLERGY | 10MG | TABLET / ORAL | 2007-12-28 | 4b0b4de00fa7… | ||
| 2019-12-13 00:20 UTC | 2019-12 | A078427-003 | CETIRIZINE HYDROCHLORIDE ALLERGY | 5MG | TABLET / ORAL | 2007-12-28 | 74a2ff9319b5… | ||
| 2019-12-13 00:20 UTC | 2019-12 | A078427-004 | CETIRIZINE HYDROCHLORIDE ALLERGY | 10MG | TABLET / ORAL | 2007-12-28 | 74a2ff9319b5… |
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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Cetirizine HCl | CETIRIZINE | Strategic Sourcing Services LLC | 65b37b00-8efc-4e04-ab97-a03e8af27d33 | 2025-04-04 | Warnings | 70677-1279-4 70677-1279-2 70677-1279-5 70677-1279-3 70677-1279-1 70677-1279 70677127903 70677127901 70677127902 70677127905 70677127904 2e9de837-00b0-491d-a2e3-766fab46380a 65b37b00-8efc-4e04-ab97-a03e8af27d33 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.

