FDA.reportPublic FDA data

Cetirizine Hydrochloride (Allergy)

Manufacturer
Aurohealth LLC | APL HEALTHCARE LIMITED | Aurobindo Pharma Limited
Effective date
2026-02-26
Label type
Human OTC Drug Label
Version
4
Source
full-release
Hydrated at
2026-06-01 01:48:29

Label at a glance#

ProductCetirizine Hydrochloride (Allergy)
Active ingredientCETIRIZINE HYDROCHLORIDE
Label structure17 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

Storage and handling

store at 20°-25°C (68°-77°F) avoid high humidity and excessive heat above 40°C (104°F) protect from light

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Cetirizine HCl Capsules 10 mg (Allergy)

Drug Facts

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 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.

When using this product

OTC - WHEN USING SECTION

  • drowsiness may occur
  • alcohol, sedatives, and tranquilizers may increase drowsiness
  • avoid alcoholic drinks
  • 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 if

OTC - STOP USE SECTION

an allergic reaction to this product occurs. Seek medical help right away.

If pregnant or breast-feeding:

OTC - PREGNANCY OR BREAST FEEDING SECTION

  • 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

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

STORAGE AND HANDLING SECTION

  • store at 20°-25°C (68°-77°F)
  • avoid high humidity and excessive heat above 40°C (104°F)
  • protect from light

Inactive ingredients

INACTIVE INGREDIENT SECTION

black iron oxide, gelatin, glycerin, hypromellose, polyethylene glycol, propylene glycol, purified water, sodium hydroxide, sorbitol sorbitan solution

Questions or comments?

OTC - QUESTIONS SECTION

call 1-855-274-4122 (Monday - Friday 8:30 AM to 5:00 PM EST)


*This product is not manufactured or distributed by the owners of Zyrtec®.

Distributed by:
AUROHEALTH LLC
279 Princeton-Hightstown Road
East Windsor, NJ 08520

 Made in India

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 10 mg (12's Capsule Container Label)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 58602-806-04

Cetirizine HCl Capsules
10 mg
Antihistamine

Indoor & Outdoor
Allergies

CZ10
(Actual size)


KEEP CARTON FOR COMPLETE WARNINGS
AND PRODUCT INFORMATION 

AUROHEALTH

12 SOFTGELS**

(** Liquid-filled capsules)

 

     PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 10 mg (12's Capsule Container Label)PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 10 mg (12's Capsule Container Label)

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL -10 mg (12's Capsule Container Carton Label)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 58602-806-04
*Compare to the active ingredient in Zyrtec®

Cetirizine HCl Capsules
10 mg
Antihistamine
Indoor & Outdoor               CZ10
Allergies                             (Actual size)

24 HOUR
Relief of:

  • Sneezing
  • Runny Nose
  • Itchy, Watery Eyes
  • Itchy Throat or Nose

AUROHEALTH

12 SOFTGELS**
(** Liquid-filled capsules)

 

   PACKAGE LABEL-PRINCIPAL DISPLAY PANEL -10 mg (12's Capsule Container Carton Label)PACKAGE LABEL-PRINCIPAL DISPLAY PANEL -10 mg (12's Capsule Container Carton Label)

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1014675cetirizine HCl 10 MG 24HR Oral CapsulePSN4
1014675cetirizine hydrochloride 10 MG Oral CapsuleSCD4
1014675cetirizine HCl 10 MG 24 HR Oral CapsuleSY4

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
58602-806-04Cetirizine Hydrochloride (Allergy)12 in 1 BOTTLECAPSULE124
58602-806-04Cetirizine Hydrochloride (Allergy)1 in 1 CARTONCAPSULE14
58602-806-12Cetirizine Hydrochloride (Allergy)40 in 1 BOTTLECAPSULE404
58602-806-12Cetirizine Hydrochloride (Allergy)1 in 1 CARTONCAPSULE14
58602-806-16Cetirizine Hydrochloride (Allergy)65 in 1 CARTONCAPSULE654
58602-806-16Cetirizine Hydrochloride (Allergy)65 in 1 BOTTLECAPSULE654
58602-806-53Cetirizine Hydrochloride (Allergy)25 in 1 BOTTLECAPSULE254
58602-806-53Cetirizine Hydrochloride (Allergy)1 in 1 CARTONCAPSULE14

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
58602-80658602-806-04, 58602-806-53, 58602-806-12, 58602-806-16

Ingredients#

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

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

Name, UNII, Kind table
NameUNIIKind
CETIRIZINE HYDROCHLORIDE64O047KTOAACTIB
FERROSOFERRIC OXIDEXM0M87F357IACT
GELATIN, UNSPECIFIED2G86QN327LIACT
GLYCERINPDC6A3C0OXIACT
HYPROMELLOSE 2910 (6 MPA.S)0WZ8WG20P6IACT
POLYETHYLENE GLYCOL 400B697894SGQIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
WATER059QF0KO0RIACT
SODIUM HYDROXIDE55X04QC32IIACT
SORBITOL506T60A25RIACT

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
A209107-001CETIRIZINE HYDROCHLORIDE ALLERGYCETIRIZINE HYDROCHLORIDE10MGCAPSULE / ORAL2018-07-20
A209107-002CETIRIZINE HYDROCHLORIDE HIVES RELIEFCETIRIZINE HYDROCHLORIDE10MGCAPSULE / ORAL2018-07-20

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 22:38:342026-08A209107-001CETIRIZINE HYDROCHLORIDE ALLERGY10MGCAPSULE / ORAL2018-07-2084e616aacf4f…
2026-09-14 22:38:342026-08A209107-002CETIRIZINE HYDROCHLORIDE HIVES RELIEF10MGCAPSULE / ORAL2018-07-2084e616aacf4f…
2026-08-18 06:07:402026-07A209107-001CETIRIZINE HYDROCHLORIDE ALLERGY10MGCAPSULE / ORAL2018-07-20caaa826d4ba7…
2026-08-18 06:07:402026-07A209107-002CETIRIZINE HYDROCHLORIDE HIVES RELIEF10MGCAPSULE / ORAL2018-07-20caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A209107-001CETIRIZINE HYDROCHLORIDE ALLERGY10MGCAPSULE / ORAL2018-07-20011fe1cb6892…
2026-02-19 14:30 UTC2026-02A209107-002CETIRIZINE HYDROCHLORIDE HIVES RELIEF10MGCAPSULE / ORAL2018-07-20011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A209107-001CETIRIZINE HYDROCHLORIDE ALLERGY10MGCAPSULE / ORAL2018-07-2031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A209107-002CETIRIZINE HYDROCHLORIDE HIVES RELIEF10MGCAPSULE / ORAL2018-07-2031067a03dcf5…
2025-08-23 18:47 UTC2025-08A209107-001CETIRIZINE HYDROCHLORIDE ALLERGY10MGCAPSULE / ORAL2018-07-206a471c1ec25d…
2025-08-23 18:47 UTC2025-08A209107-002CETIRIZINE HYDROCHLORIDE HIVES RELIEF10MGCAPSULE / ORAL2018-07-206a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A209107-001CETIRIZINE HYDROCHLORIDE ALLERGY10MGCAPSULE / ORAL2018-07-20fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A209107-002CETIRIZINE HYDROCHLORIDE HIVES RELIEF10MGCAPSULE / ORAL2018-07-20fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A209107-001CETIRIZINE HYDROCHLORIDE ALLERGY10MGCAPSULE / ORAL2018-07-20b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A209107-002CETIRIZINE HYDROCHLORIDE HIVES RELIEF10MGCAPSULE / ORAL2018-07-20b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A209107-001CETIRIZINE HYDROCHLORIDE ALLERGY10MGCAPSULE / ORAL2018-07-2003ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A209107-002CETIRIZINE HYDROCHLORIDE HIVES RELIEF10MGCAPSULE / ORAL2018-07-2003ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A209107-001CETIRIZINE HYDROCHLORIDE ALLERGY10MGCAPSULE / ORAL2018-07-202680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A209107-002CETIRIZINE HYDROCHLORIDE HIVES RELIEF10MGCAPSULE / ORAL2018-07-202680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A209107-001CETIRIZINE HYDROCHLORIDE ALLERGY10MGCAPSULE / ORAL2018-07-205bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A209107-002CETIRIZINE HYDROCHLORIDE HIVES RELIEF10MGCAPSULE / ORAL2018-07-205bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A209107-001CETIRIZINE HYDROCHLORIDE ALLERGY10MGCAPSULE / ORAL2018-07-20d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A209107-002CETIRIZINE HYDROCHLORIDE HIVES RELIEF10MGCAPSULE / ORAL2018-07-20d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A209107-001CETIRIZINE HYDROCHLORIDE ALLERGY10MGCAPSULE / ORAL2018-07-20d06236e962d9…
2024-10-29 15:01 UTC2024-10A209107-002CETIRIZINE HYDROCHLORIDE HIVES RELIEF10MGCAPSULE / ORAL2018-07-20d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A209107-001CETIRIZINE HYDROCHLORIDE ALLERGY10MGCAPSULE / ORAL2018-07-2079d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A209107-002CETIRIZINE HYDROCHLORIDE HIVES RELIEF10MGCAPSULE / ORAL2018-07-2079d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A209107-001CETIRIZINE HYDROCHLORIDE ALLERGY10MGCAPSULE / ORAL2018-07-20301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A209107-002CETIRIZINE HYDROCHLORIDE HIVES RELIEF10MGCAPSULE / ORAL2018-07-20301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A209107-001CETIRIZINE HYDROCHLORIDE ALLERGY10MGCAPSULE / ORAL2018-07-201e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A209107-002CETIRIZINE HYDROCHLORIDE HIVES RELIEF10MGCAPSULE / ORAL2018-07-201e350fbaab3a…
2024-05-31 18:47 UTC2024-05A209107-001CETIRIZINE HYDROCHLORIDE ALLERGY10MGCAPSULE / ORAL2018-07-208072bd15b7f6…
2024-05-31 18:47 UTC2024-05A209107-002CETIRIZINE HYDROCHLORIDE HIVES RELIEF10MGCAPSULE / ORAL2018-07-208072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A209107-001CETIRIZINE HYDROCHLORIDE ALLERGY10MGCAPSULE / ORAL2018-07-205c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A209107-002CETIRIZINE HYDROCHLORIDE HIVES RELIEF10MGCAPSULE / ORAL2018-07-205c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A209107-001CETIRIZINE HYDROCHLORIDE ALLERGY10MGCAPSULE / ORAL2018-07-205d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A209107-002CETIRIZINE HYDROCHLORIDE HIVES RELIEF10MGCAPSULE / ORAL2018-07-205d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A209107-001CETIRIZINE HYDROCHLORIDE ALLERGY10MGCAPSULE / ORAL2018-07-204b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A209107-002CETIRIZINE HYDROCHLORIDE HIVES RELIEF10MGCAPSULE / ORAL2018-07-204b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A209107-001CETIRIZINE HYDROCHLORIDE ALLERGY10MGCAPSULE / ORAL2018-07-2074a2ff9319b5…
2019-12-13 00:20 UTC2019-12A209107-002CETIRIZINE HYDROCHLORIDE HIVES RELIEF10MGCAPSULE / ORAL2018-07-2074a2ff9319b5…

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 Hydrochloride (Allergy)CETIRIZINE HYDROCHLORIDEAurohealth LLCffbca2a4-8df0-4c85-adf9-9414cd706fb22026-02-26WarningsExact identifier
ndc (package): 58602-806-16
ndc (package): 58602-806-04
ndc (package): 58602-806-53
ndc (package): 58602-806-12
ndc (product): 58602-806
ndc11 (package): 58602080653
ndc11 (package): 58602080616
ndc11 (package): 58602080604
ndc11 (package): 58602080612
spl id: a74bd49f-8718-4483-9019-b761138669c9
spl set id: ffbca2a4-8df0-4c85-adf9-9414cd706fb2

Reported adverse events (FAERS/openFDA)#

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