Cetirizine Hydrochloride (Hives Relief)

Manufacturer
Aurohealth LLC | APL HEALTHCARE LIMITED | Aurobindo Pharma Limited
Effective date
2020-09-14
Label type
Human OTC Drug Label
Version
4
Source
full-release
Hydrated at
2026-05-31 23:29:21

Label at a glance#

ProductCetirizine Hydrochloride (Hives Relief)
Active ingredientCETIRIZINE HYDROCHLORIDE
Label structure18 sections

Indications and uses

relieves itching due to hives (urticaria). This product will not prevent hives or an allergic skin reaction from occuring.

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 between 20° - 25°C (68° - 77°F)  avoid high humidity and excessive heat above 40°C (104°F)  protect from light  do not use if seal imprinted with SEALED for YOUR PROTECTION under the bottle cap is broken or missing.

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Cetirizine HCl Capsules 10 mg (Hives Relief)

Drug Facts

Active ingredient (in each capsule)

OTC - ACTIVE INGREDIENT SECTION

Cetirizine HCI USP 10 mg

Purpose

OTC - PURPOSE SECTION


Antihistamine

Uses

INDICATIONS & USAGE SECTION


relieves itching due to hives (urticaria). This product will not prevent hives or an allergic skin reaction from occuring.

Warnings

WARNINGS SECTION

Severe Allergy Warning: Get emergency help immediately if you have hives along with any of the following symptoms:


  • trouble swallowing
  • dizziness or loss of consciousness
  • swelling of tongue
  • swelling in or around mouth
  • trouble speaking
  • drooling
  • wheezing or problems breathing

These symptoms may be signs of anaphylactic shock. This condition can be life threatening if not treated by a health professional immediately. Symptoms of anaphylactic shock may occur when hives first appear or up to a few hours later.

Not a Substitute for Epinephrine. If your doctor has prescribed an epinephrine injector for "anaphylaxis" or severe allergy symptoms that could occur with your hives, never use this product as a substitute for the epinephrine injector. If you have been prescribed an epinephrine injector, you should carry it with you at all times.


Do not use

OTC - DO NOT USE SECTION

  • to prevent hives from any known cause such as:
    • foods
    • insect stings
    • medicines
    • latex or rubber gloves

because this product will not stop hives from occuring. Avoiding the cause of your hives is the only way to prevent them. Hives can sometimes be serious. If you do not know the cause of your hives, see your doctor for a medical exam. Your doctor may be able to help you find a cause.

  • if 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 have

OTC - ASK DOCTOR SECTION

  • liver or kidney disease. Your doctor should determine if you need a different dose.
  • hives that are an unusual color, look bruised or blistered
  • hives that do not itch

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
  • 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

OTC - STOP USE SECTION

  • an allergic reaction to this product occurs. Seek medical help right away.
  • symptoms do not improve after 3 days of treatment.
  • the hives have lasted more than 6 weeks.

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 between 20° - 25°C (68° - 77°F)
  •  avoid high humidity and excessive heat above 40°C (104°F)
  •  protect from light
  •  do not use if seal imprinted with SEALED for YOUR PROTECTION under the bottle cap is broken or missing.

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)

Distributed by:
AUROHEALTH LLC
2572 Brunswick Pike
Lawrenceville, NJ 08648

Made in India

Code: TS/DRUGS/22/2009

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

HIVES Relief     NDC 58602-808-04
Original Prescription Strength

Cetirizine HCl Capsules
10 mg                                             CZ10
Antihistamine                            (Actual Size) 

READ AND KEEP THE OUTER PACKAGE FOR
COMPLETE WARNINGS AND INFORMATION

12 LIQUID GELS*

* LIQUID-FILLED CAPSULES
AUROHEALTH
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 58602-808-04
*Compare to the active ingredient in Zyrtec®
Original Prescription Strength
HIVES Relief

Cetirizine HCl Capsules

10 mg
Antihistamine

24 hour                                                      CZ10

Relief of itching due to hives               (Actual Size)

12 LIQUID GELS*

* LIQUID-FILLED CAPSULES
AUROHEALTH


PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 10 mg (Carton Label)
PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 10 mg (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
58602-808-04Cetirizine Hydrochloride (Hives Relief)12 in 1 BOTTLECAPSULE124
58602-808-04Cetirizine Hydrochloride (Hives Relief)1 in 1 CARTONCAPSULE14
58602-808-12Cetirizine Hydrochloride (Hives Relief)1 in 1 CARTONCAPSULE14
58602-808-12Cetirizine Hydrochloride (Hives Relief)40 in 1 BOTTLECAPSULE404
58602-808-16Cetirizine Hydrochloride (Hives Relief)65 in 1 BOTTLECAPSULE654
58602-808-16Cetirizine Hydrochloride (Hives Relief)65 in 1 CARTONCAPSULE654
58602-808-53Cetirizine Hydrochloride (Hives Relief)1 in 1 CARTONCAPSULE14
58602-808-53Cetirizine Hydrochloride (Hives Relief)25 in 1 BOTTLECAPSULE254

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
58602-808CETIRIZINE HYDROCHLORIDE (HIVES RELIEF) (CETIRIZINE HYDROCHLORIDE) CAPSULE [AUROHEALTH LLC]4Current NDC, Legacy NDC, 8 package rows20200915_f0f486e1-2eeb-4eaa-b557-908bcbf973a8.zip

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
58602-80858602-808-04, 58602-808-53, 58602-808-12, 58602-808-16

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
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 (Hives Relief)CETIRIZINE HYDROCHLORIDEAurohealth LLCf0f486e1-2eeb-4eaa-b557-908bcbf973a82020-09-14WarningsExact identifier
ndc (package): 58602-808-53
ndc (package): 58602-808-12
ndc (package): 58602-808-04
ndc (package): 58602-808-16
ndc (product): 58602-808
ndc11 (package): 58602080804
ndc11 (package): 58602080812
ndc11 (package): 58602080853
ndc11 (package): 58602080816
spl id: 30494d65-a846-4f13-a076-242f193e4651
spl set id: f0f486e1-2eeb-4eaa-b557-908bcbf973a8

Reported adverse events (FAERS/openFDA)#

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