CETIRIZINE HYDROCHLORIDE - Aurohealth LLC | APL HEALTHCARE LIMITED

Manufacturer
Aurohealth LLC | APL HEALTHCARE LIMITED
Effective date
2026-08-25
Label type
Human OTC Drug Label
Version
4
Source
daily-update
Hydrated at
2026-09-04 01:01:09

Label at a glance#

ProductCetirizine Hydrochloride and Pseudoephedrine Hydrochloride
Active ingredientCETIRIZINE HYDROCHLORIDE, PSEUDOEPHEDRINE HYDROCHLORIDE
Label structure13 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 nasal congestion reduces swelling of nasal passages temporarily relieves sinus congestion and pressure temporarily restores freer breathing through the nose

Dosage and administration

do not break or chew tablet; swallow tablet whole adults and children 12 years and over take 1 tablet every 12 hours; do not take more than 2 tablets in 24 hours.  adults 65 years and over ask a doctor children under 12 years of age ask a doctor consumers with liver or kidney disease ask a doctor

Storage and handling

store between 20° to 25°C (68° to 77°F) do not use if carton is opened or if individual blister units are torn or broken

Label contents#

Full prescribing information#

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

Active ingredients (in each extended release tablet)

Cetirizine HCl USP 5 mg
Pseudoephedrine HCl  USP 120 mg

Purpose

OTC - PURPOSE SECTION

Antihistamine
Nasal decongestant

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
    • nasal congestion
  • reduces swelling of nasal passages
  • temporarily relieves sinus congestion and pressure
  • temporarily restores freer breathing through the nose

Do not use

OTC - DO NOT USE SECTION

  • if you have ever had an allergic reaction to this product or any of its ingredients or to an antihistamine containing hydroxyzine.
  • if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson’s disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.

Ask a doctor before use if you have

OTC - ASK DOCTOR SECTION

 

  • heart disease
  • thyroid disease
  • diabetes
  • glaucoma
  • high blood pressure
  • trouble urinating due to an enlarged prostate gland
  • 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

OTC - WHEN USING SECTION

  • do not use more than directed
  • 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 if

OTC - STOP USE SECTION


  • an allergic reaction to this product occurs. Seek medical help right away.
  • you get nervous, dizzy, or sleepless
  • symptoms do not improve within 7 days or are accompanied by fever

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

  • do not break or chew tablet; swallow tablet whole
adults and children 12 years and over
take 1 tablet every 12 hours; do not take more than 2 tablets in 24 hours. 
adults 65 years and over
ask a doctor
children under 12 years of age
ask a doctor
consumers with liver or kidney disease
ask a doctor

Other information

STORAGE AND HANDLING SECTION

  • store between 20° to 25°C (68° to 77°F)
  • do not use if carton is opened or if individual blister units are torn or broken

Inactive ingredients

INACTIVE INGREDIENT SECTION

colloidal silicon dioxide, croscarmellose sodium, ferric oxide, hypromellose, magnesium stearate, microcrystalline cellulose.

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

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

Made in India 

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL -5 mg/120 mg (12 x 2) Blister Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

AUROHEALTH

NDC 58602-703-09

*Compare to the active
ingredients of Zyrtec-D®

Original Prescription Strength

Cetirizine Hydrochloride and
Pseudoephedrine Hydrochloride
Extended-Release Tablets, USP
5 mg/120 mg

Antihistamine/Nasal Decongestant

Indoor & Outdoor
Allergies


ALLERY + SINUS

NASAL CONGESTION + SINUS PRESSURE

12 Hour
relief of
Sneezing
Runny Nose
Itchy, Watery Eyes
Itchy Throat or Nose

Actual Size
24
EXTENDED-RELEASE TABLETS

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL -5 mg/120 mg (12 x 2) Blister CartonPACKAGE LABEL-PRINCIPAL DISPLAY PANEL -5 mg/120 mg (12 x 2) Blister Carton

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
ba088a92-ab5e-b2d4-e908-f5ea691b7587Product name720210201
c505bb17-4ff9-45f9-ac2d-bb9c8c9d35beProduct name120200304
a255659f-db40-429d-8c07-5f173f330d9cProduct name120190402
0fdb98e2-b951-a1ce-5715-2b187ba500efProduct name420170718
e974e22d-8688-7d92-1e87-40c1079e170cProduct name320151125
e8718272-64cb-4436-969b-176c3067c8f4Product name120150609
30c51294-7ae9-8007-7de6-58222684a0beProduct name120140508
4f26f669-fc6c-40ef-9e26-1c7b2390ee66Product name120140508
70a83adc-6047-bbea-5a08-dfd304aa47d2Product name120140508
858ce051-9941-aafc-8c7c-44a8e0227463Product name120140508
b893258d-0942-3d8a-3411-056ea0788ff5Product name120140508

Products#

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

DailyMed product names page 1 of 1 · 11 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
58602-70358602-703-76, 58602-703-75, 58602-703-53, 58602-703-09

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 8 matching rows.

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
32024-11-07full-release2026-06-01 00:37:20

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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A212409-001CETIRIZINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDECETIRIZINE HYDROCHLORIDE; PSEUDOEPHEDRINE HYDROCHLORIDE5MG;120MGTABLET, EXTENDED RELEASE / ORAL2023-03-08

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 table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A212409-001CETIRIZINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE5MG;120MGTABLET, EXTENDED RELEASE / ORAL2023-03-0884e616aacf4f…
2026-08-18 06:07:402026-07A212409-001CETIRIZINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE5MG;120MGTABLET, EXTENDED RELEASE / ORAL2023-03-08caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A212409-001CETIRIZINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE5MG;120MGTABLET, EXTENDED RELEASE / ORAL2023-03-08011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A212409-001CETIRIZINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE5MG;120MGTABLET, EXTENDED RELEASE / ORAL2023-03-0831067a03dcf5…
2025-08-23 18:47 UTC2025-08A212409-001CETIRIZINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE5MG;120MGTABLET, EXTENDED RELEASE / ORAL2023-03-086a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A212409-001CETIRIZINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE5MG;120MGTABLET, EXTENDED RELEASE / ORAL2023-03-08fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A212409-001CETIRIZINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE5MG;120MGTABLET, EXTENDED RELEASE / ORAL2023-03-08b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A212409-001CETIRIZINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE5MG;120MGTABLET, EXTENDED RELEASE / ORAL2023-03-0803ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A212409-001CETIRIZINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE5MG;120MGTABLET, EXTENDED RELEASE / ORAL2023-03-082680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A212409-001CETIRIZINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE5MG;120MGTABLET, EXTENDED RELEASE / ORAL2023-03-085bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A212409-001CETIRIZINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE5MG;120MGTABLET, EXTENDED RELEASE / ORAL2023-03-08d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A212409-001CETIRIZINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE5MG;120MGTABLET, EXTENDED RELEASE / ORAL2023-03-08d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A212409-001CETIRIZINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE5MG;120MGTABLET, EXTENDED RELEASE / ORAL2023-03-0879d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A212409-001CETIRIZINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE5MG;120MGTABLET, EXTENDED RELEASE / ORAL2023-03-08301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A212409-001CETIRIZINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE5MG;120MGTABLET, EXTENDED RELEASE / ORAL2023-03-081e350fbaab3a…
2024-05-31 18:47 UTC2024-05A212409-001CETIRIZINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE5MG;120MGTABLET, EXTENDED RELEASE / ORAL2023-03-088072bd15b7f6…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A212409-001CETIRIZINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE5MG;120MGTABLET, EXTENDED RELEASE / ORAL2023-03-086a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A212409-001CETIRIZINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE5MG;120MGTABLET, EXTENDED RELEASE / ORAL2023-03-081c564ffb4f44…
2023-12-20 04:57 UTC2023-12A212409-001CETIRIZINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE5MG;120MGTABLET, EXTENDED RELEASE / ORAL2023-03-08ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A212409-001CETIRIZINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE5MG;120MGTABLET, EXTENDED RELEASE / ORAL2023-03-08a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A212409-001CETIRIZINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE5MG;120MGTABLET, EXTENDED RELEASE / ORAL2023-03-089b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A212409-001CETIRIZINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE5MG;120MGTABLET, EXTENDED RELEASE / ORAL2023-03-08a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A212409-001CETIRIZINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE5MG;120MGTABLET, EXTENDED RELEASE / ORAL2023-03-083f0d92c62455…
2023-05-13 08:27 UTC2023-05A212409-001CETIRIZINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE5MG;120MGTABLET, EXTENDED RELEASE / ORAL2023-03-08053a50430f4f…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A212409-001CETIRIZINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE5MG;120MGTABLET, EXTENDED RELEASE / ORAL2023-03-08a50c72e98297…

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 and Pseudoephedrine HydrochlorideCETIRIZINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDEAurohealth LLC26f2c3c1-a2f2-474a-950a-8cfe07f289fa2026-08-25WarningsExact identifier
ndc (package): 58602-703-75
ndc (package): 58602-703-09
ndc (package): 58602-703-76
ndc (package): 58602-703-53
ndc (product): 58602-703
ndc11 (package): 58602070353
ndc11 (package): 58602070375
ndc11 (package): 58602070376
ndc11 (package): 58602070309
spl id: 36996eb4-9195-4bfc-a687-fdb4ea05a860
spl set id: 26f2c3c1-a2f2-474a-950a-8cfe07f289fa

Reported adverse events (FAERS/openFDA)#

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