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#

ProductCetirizine HCl
Active ingredientCETIRIZINE HYDROCHLORIDE
Label structure10 sections

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.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

SPL UNCLASSIFIED SECTION

  • 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

www.fosterandthrive.com

Product of India

April 2025

Package/Label Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Container label

NDC 70677-1279-5

10 mg - 300 Tablets

label10mg300s
label10mg300s

Package/Label Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Carton label

NDC 70677-1279-5

10 mg- 300 Tablets

carton10mg300s
carton10mg300s

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1014678cetirizine HCl 10 MG Oral TabletPSN3
1014678cetirizine hydrochloride 10 MG Oral TabletSCD3
1014678cetirizine HCl 10 MG Oral TabletSY3

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
CETIRIZINE Pharmacologic Class Indexing3Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
c505bb17-4ff9-45f9-ac2d-bb9c8c9d35beProduct name120200304
a255659f-db40-429d-8c07-5f173f330d9cProduct name120190402

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70677-1279-1Cetirizine HCl14 in 1 BOTTLETABLET143
70677-1279-1Cetirizine HCl1 in 1 CARTONTABLET13
70677-1279-2Cetirizine HCl30 in 1 BOTTLETABLET303
70677-1279-2Cetirizine HCl1 in 1 CARTONTABLET13
70677-1279-3Cetirizine HCl1 in 1 CARTONTABLET13
70677-1279-3Cetirizine HCl60 in 1 BOTTLETABLET603
70677-1279-4Cetirizine HCl1 in 1 CARTONTABLET13
70677-1279-4Cetirizine HCl90 in 1 BOTTLETABLET903
70677-1279-5Cetirizine HCl300 in 1 BOTTLETABLET3003
70677-1279-5Cetirizine HCl1 in 1 CARTONTABLET13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70677-1279CETIRIZINE HCL (CETIRIZINE) TABLET [STRATEGIC SOURCING SERVICES LLC]3Current NDC, 10 package rows20250406_65b37b00-8efc-4e04-ab97-a03e8af27d33.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70677-1279-1EA - Each70677-127963246e3e-43d7-4378-98dd-078c5443cc7d12025-05-14
70677-1279-2EA - Each70677-1279eb504316-ffda-49c2-8db3-b1e1855fe4b612025-05-14
70677-1279-3EA - Each70677-12792e39a72d-e107-4a01-b0ba-1bdc100a49b512025-05-14
70677-1279-4EA - Each70677-1279853f8a6b-588b-4a74-8561-6519d131827312025-05-14
70677-1279-5EA - Each70677-1279674b3c93-67e0-4d42-b057-8eaeefde5ad212025-05-14

Products#

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

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

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
70677-127970677-1279-2, 70677-1279-3, 70677-1279-4, 70677-1279-5, 70677-1279-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 10 matching rows.

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 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A078427-003CETIRIZINE HYDROCHLORIDE ALLERGYCETIRIZINE HYDROCHLORIDE5MGTABLET / ORAL2007-12-28
A078427-004CETIRIZINE HYDROCHLORIDE ALLERGYCETIRIZINE HYDROCHLORIDE10MGTABLET / ORAL2007-12-28

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.

Product history page 1 of 3 · 86 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A078427-003CETIRIZINE HYDROCHLORIDE ALLERGY5MGTABLET / ORAL2007-12-2884e616aacf4f…
2026-09-14 22:38:342026-08A078427-004CETIRIZINE HYDROCHLORIDE ALLERGY10MGTABLET / ORAL2007-12-2884e616aacf4f…
2026-08-18 06:07:402026-07A078427-003CETIRIZINE HYDROCHLORIDE ALLERGY5MGTABLET / ORAL2007-12-28caaa826d4ba7…
2026-08-18 06:07:402026-07A078427-004CETIRIZINE HYDROCHLORIDE ALLERGY10MGTABLET / ORAL2007-12-28caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A078427-003CETIRIZINE HYDROCHLORIDE ALLERGY5MGTABLET / ORAL2007-12-28011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078427-004CETIRIZINE HYDROCHLORIDE ALLERGY10MGTABLET / ORAL2007-12-28011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078427-003CETIRIZINE HYDROCHLORIDE ALLERGY5MGTABLET / ORAL2007-12-2831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078427-004CETIRIZINE HYDROCHLORIDE ALLERGY10MGTABLET / ORAL2007-12-2831067a03dcf5…
2025-08-23 18:47 UTC2025-08A078427-003CETIRIZINE HYDROCHLORIDE ALLERGY5MGTABLET / ORAL2007-12-286a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078427-004CETIRIZINE HYDROCHLORIDE ALLERGY10MGTABLET / ORAL2007-12-286a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078427-003CETIRIZINE HYDROCHLORIDE ALLERGY5MGTABLET / ORAL2007-12-28fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078427-004CETIRIZINE HYDROCHLORIDE ALLERGY10MGTABLET / ORAL2007-12-28fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078427-003CETIRIZINE HYDROCHLORIDE ALLERGY5MGTABLET / ORAL2007-12-28b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078427-004CETIRIZINE HYDROCHLORIDE ALLERGY10MGTABLET / ORAL2007-12-28b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078427-003CETIRIZINE HYDROCHLORIDE ALLERGY5MGTABLET / ORAL2007-12-2803ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078427-004CETIRIZINE HYDROCHLORIDE ALLERGY10MGTABLET / ORAL2007-12-2803ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078427-003CETIRIZINE HYDROCHLORIDE ALLERGY5MGTABLET / ORAL2007-12-282680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078427-004CETIRIZINE HYDROCHLORIDE ALLERGY10MGTABLET / ORAL2007-12-282680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078427-003CETIRIZINE HYDROCHLORIDE ALLERGY5MGTABLET / ORAL2007-12-285bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078427-004CETIRIZINE HYDROCHLORIDE ALLERGY10MGTABLET / ORAL2007-12-285bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078427-003CETIRIZINE HYDROCHLORIDE ALLERGY5MGTABLET / ORAL2007-12-28d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078427-004CETIRIZINE HYDROCHLORIDE ALLERGY10MGTABLET / ORAL2007-12-28d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A078427-003CETIRIZINE HYDROCHLORIDE ALLERGY5MGTABLET / ORAL2007-12-28d06236e962d9…
2024-10-29 15:01 UTC2024-10A078427-004CETIRIZINE HYDROCHLORIDE ALLERGY10MGTABLET / ORAL2007-12-28d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A078427-003CETIRIZINE HYDROCHLORIDE ALLERGY5MGTABLET / ORAL2007-12-2879d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A078427-004CETIRIZINE HYDROCHLORIDE ALLERGY10MGTABLET / ORAL2007-12-2879d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A078427-003CETIRIZINE HYDROCHLORIDE ALLERGY5MGTABLET / ORAL2007-12-28301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A078427-004CETIRIZINE HYDROCHLORIDE ALLERGY10MGTABLET / ORAL2007-12-28301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A078427-003CETIRIZINE HYDROCHLORIDE ALLERGY5MGTABLET / ORAL2007-12-281e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A078427-004CETIRIZINE HYDROCHLORIDE ALLERGY10MGTABLET / ORAL2007-12-281e350fbaab3a…
2024-05-31 18:47 UTC2024-05A078427-003CETIRIZINE HYDROCHLORIDE ALLERGY5MGTABLET / ORAL2007-12-288072bd15b7f6…
2024-05-31 18:47 UTC2024-05A078427-004CETIRIZINE HYDROCHLORIDE ALLERGY10MGTABLET / ORAL2007-12-288072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A078427-003CETIRIZINE HYDROCHLORIDE ALLERGY5MGTABLET / ORAL2007-12-285c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A078427-004CETIRIZINE HYDROCHLORIDE ALLERGY10MGTABLET / ORAL2007-12-285c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A078427-003CETIRIZINE HYDROCHLORIDE ALLERGY5MGTABLET / ORAL2007-12-285d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A078427-004CETIRIZINE HYDROCHLORIDE ALLERGY10MGTABLET / ORAL2007-12-285d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A078427-003CETIRIZINE HYDROCHLORIDE ALLERGY5MGTABLET / ORAL2007-12-284b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A078427-004CETIRIZINE HYDROCHLORIDE ALLERGY10MGTABLET / ORAL2007-12-284b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A078427-003CETIRIZINE HYDROCHLORIDE ALLERGY5MGTABLET / ORAL2007-12-2874a2ff9319b5…
2019-12-13 00:20 UTC2019-12A078427-004CETIRIZINE HYDROCHLORIDE ALLERGY10MGTABLET / ORAL2007-12-2874a2ff9319b5…

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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Cetirizine HClCETIRIZINEStrategic Sourcing Services LLC65b37b00-8efc-4e04-ab97-a03e8af27d332025-04-04WarningsExact identifier
ndc (package): 70677-1279-4
ndc (package): 70677-1279-2
ndc (package): 70677-1279-5
ndc (package): 70677-1279-3
ndc (package): 70677-1279-1
ndc (product): 70677-1279
ndc11 (package): 70677127903
ndc11 (package): 70677127901
ndc11 (package): 70677127902
ndc11 (package): 70677127905
ndc11 (package): 70677127904
spl id: 2e9de837-00b0-491d-a2e3-766fab46380a
spl set id: 65b37b00-8efc-4e04-ab97-a03e8af27d33

Reported adverse events (FAERS/openFDA)#

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