FDA.reportPublic FDA data

Pentrexcilina Day time

Manufacturer
OPMX LLC | Granules India Limited
Effective date
2024-11-15
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 00:37:55

Label at a glance#

ProductPentrexcilina Day time
Active ingredientCETIRIZINE HYDROCHLORIDE
Label structure10 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 & Children 6 years and over One 10mg tablet once daily; do not take more than one 10mg 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 ask a doctor Consumers with liver or kidney disease ask a doctor

Storage and handling

tore at room temperature between 20-25°C (68-77°F). close cap tightly after use. contains no ingredients made from a gluten-containing grain (wheat, barley or rye). TAMPER EVIDENT: Do not use if imprinted safety seal is broken or missing

Label contents#

Full prescribing information#

Drug Facts

SPL UNCLASSIFIED SECTION

Drug Facts

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Active Ingredient (in each tablet)Purpose
Cetirizine HCl 10 mgAntihistamine

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

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

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.

Ask a doctor or pharmacist before use if you are

OTC - ASK DOCTOR/PHARMACIST SECTION

taking sedatives or tranquilizers.

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.

If pregnant or breast-feeding,

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a health professional before use.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

OVERDOSE WARNING:

OVERDOSAGE SECTION

In case of overdose, get medical help or contact a Poison Control Center right away. Prompt medical attention is critical for adults as well as children even if you do not notice any signs or symptoms.

Directions

DOSAGE & ADMINISTRATION SECTION

Adults & Children 6 years and over One 10mg tablet once daily; do not take more than one 10mg 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 ask a doctor

Consumers with liver or kidney disease ask a doctor

Other information

STORAGE AND HANDLING SECTION

tore at room temperature between 20-25°C (68-77°F).

close cap tightly after use.

contains no ingredients made from a gluten-containing grain (wheat, barley or rye).

TAMPER EVIDENT: Do not use if imprinted safety seal is broken or missing

Inactive ingredients

INACTIVE INGREDIENT SECTION

colloidal silicon dioxide, croscarmellose sodium, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, titanium dioxide.

Questions or comments?

OTC - QUESTIONS SECTION

Call (619) 600-5632

Monday through Friday 9 AM- 5 PM EST

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Principal display panel All dayPrincipal display panel All dayPentrexcilina display panelPentrexcilina display panel

Daytime Xtreme Allergy Relief

Cetirizine HCl 10mg

Non-Drowsy

NDC 69729-137-14

14 Tablets

DUO PACK

PENTREXCILINA

ALL DAY & ALL NIGHT

24 HOUR ALLERGY RELIEF OF:

  • Sneezing/ Estornudos
  • Runny nose/ Escurrimiento nasal
  • Itchy, watery eyes/ Irritación y ojos llorosos
  • Itchy throat/ Picazón en garganta

Nighttime Severe Allergy Relief

Sleep-aid

Diphenhydramine HCl 25mg

NDC 69729-106-14

14 Caplets

Made for RRX

Exclusively distributed by:

OPMX

Chula Vista CA 91910

Phone: 619-600-5632

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1014678cetirizine HCl 10 MG Oral TabletPSN1
1014678cetirizine hydrochloride 10 MG Oral TabletSCD1
1014678cetirizine HCl 10 MG Oral TabletSY1

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
69729-137-14Pentrexcilina Day time14 in 1 BOTTLETABLET141

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69729-137PENTREXCILINA DAY TIME (CETIRIZINE HYDROCHLORIDE) TABLET [OPMX LLC]1Current NDC, 1 package rows20241121_26f56cb7-be58-a0c2-e063-6294a90a15fa.zip

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
69729-13769729-137-14

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 9 matching rows.

Name, UNII, Kind table
NameUNIIKind
MICROCRYSTALLINE CELLULOSEOP1R32D61UIACT
POLYETHYLENE GLYCOL, UNSPECIFIED3WJQ0SDW1AIACT
LACTOSE MONOHYDRATEEWQ57Q8I5XIACT
CROSCARMELLOSE SODIUMM28OL1HH48IACT
CETIRIZINE HYDROCHLORIDE64O047KTOAACTIB
HYPROMELLOSE, UNSPECIFIED3NXW29V3WOIACT
TITANIUM DIOXIDE15FIX9V2JPIACT
SILICON DIOXIDEETJ7Z6XBU4IACT
MAGNESIUM STEARATE70097M6I30IACT

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 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A209274-001CETIRIZINE HYDROCHLORIDE ALLERGYCETIRIZINE HYDROCHLORIDE10MGTABLET / ORAL2017-12-22

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 2 · 43 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A209274-001CETIRIZINE HYDROCHLORIDE ALLERGY10MGTABLET / ORAL2017-12-2284e616aacf4f…
2026-08-18 06:07:402026-07A209274-001CETIRIZINE HYDROCHLORIDE ALLERGY10MGTABLET / ORAL2017-12-22caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A209274-001CETIRIZINE HYDROCHLORIDE ALLERGY10MGTABLET / ORAL2017-12-22011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A209274-001CETIRIZINE HYDROCHLORIDE ALLERGY10MGTABLET / ORAL2017-12-2231067a03dcf5…
2025-08-23 18:47 UTC2025-08A209274-001CETIRIZINE HYDROCHLORIDE ALLERGY10MGTABLET / ORAL2017-12-226a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A209274-001CETIRIZINE HYDROCHLORIDE ALLERGY10MGTABLET / ORAL2017-12-22fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A209274-001CETIRIZINE HYDROCHLORIDE ALLERGY10MGTABLET / ORAL2017-12-22b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A209274-001CETIRIZINE HYDROCHLORIDE ALLERGY10MGTABLET / ORAL2017-12-2203ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A209274-001CETIRIZINE HYDROCHLORIDE ALLERGY10MGTABLET / ORAL2017-12-222680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A209274-001CETIRIZINE HYDROCHLORIDE ALLERGY10MGTABLET / ORAL2017-12-225bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A209274-001CETIRIZINE HYDROCHLORIDE ALLERGY10MGTABLET / ORAL2017-12-22d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A209274-001CETIRIZINE HYDROCHLORIDE ALLERGY10MGTABLET / ORAL2017-12-22d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A209274-001CETIRIZINE HYDROCHLORIDE ALLERGY10MGTABLET / ORAL2017-12-2279d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A209274-001CETIRIZINE HYDROCHLORIDE ALLERGY10MGTABLET / ORAL2017-12-22301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A209274-001CETIRIZINE HYDROCHLORIDE ALLERGY10MGTABLET / ORAL2017-12-221e350fbaab3a…
2024-05-31 18:47 UTC2024-05A209274-001CETIRIZINE HYDROCHLORIDE ALLERGY10MGTABLET / ORAL2017-12-228072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A209274-001CETIRIZINE HYDROCHLORIDE ALLERGY10MGTABLET / ORAL2017-12-225c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A209274-001CETIRIZINE HYDROCHLORIDE ALLERGY10MGTABLET / ORAL2017-12-225d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A209274-001CETIRIZINE HYDROCHLORIDE ALLERGY10MGTABLET / ORAL2017-12-224b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A209274-001CETIRIZINE HYDROCHLORIDE ALLERGY10MGTABLET / ORAL2017-12-2274a2ff9319b5…
2022-03-09 01:35 UTC2022-03A209274-001CETIRIZINE HYDROCHLORIDE ALLERGY10MGTABLET / ORAL2017-12-22bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A209274-001CETIRIZINE HYDROCHLORIDE ALLERGY10MGTABLET / ORAL2017-12-22782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A209274-001CETIRIZINE HYDROCHLORIDE ALLERGY10MGTABLET / ORAL2017-12-2287673890dc5c…
2021-03-12 10:30 UTC2021-03A209274-001CETIRIZINE HYDROCHLORIDE ALLERGY10MGTABLET / ORAL2017-12-225aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A209274-001CETIRIZINE HYDROCHLORIDE ALLERGY10MGTABLET / ORAL2017-12-228869cabd3fbd…
2020-11-12 02:37 UTC2020-11A209274-001CETIRIZINE HYDROCHLORIDE ALLERGY10MGTABLET / ORAL2017-12-22c0c555d07b60…
2019-12-14 00:12 UTC2019-12A209274-001CETIRIZINE HYDROCHLORIDE ALLERGY10MGTABLET / ORAL2017-12-223f01610625f2…
2019-09-15 20:21 UTC2019-09A209274-001CETIRIZINE HYDROCHLORIDE ALLERGY10MGTABLET / ORAL2017-12-22b00525d2431f…
2019-07-19 19:46 UTC2019-07A209274-001CETIRIZINE HYDROCHLORIDE ALLERGY10MGTABLET / ORAL2017-12-22ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A209274-001CETIRIZINE HYDROCHLORIDE ALLERGY10MGTABLET / ORAL2017-12-226a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A209274-001CETIRIZINE HYDROCHLORIDE ALLERGY10MGTABLET / ORAL2017-12-221c564ffb4f44…
2023-12-20 04:57 UTC2023-12A209274-001CETIRIZINE HYDROCHLORIDE ALLERGY10MGTABLET / ORAL2017-12-22ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A209274-001CETIRIZINE HYDROCHLORIDE ALLERGY10MGTABLET / ORAL2017-12-22a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A209274-001CETIRIZINE HYDROCHLORIDE ALLERGY10MGTABLET / ORAL2017-12-229b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A209274-001CETIRIZINE HYDROCHLORIDE ALLERGY10MGTABLET / ORAL2017-12-22a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A209274-001CETIRIZINE HYDROCHLORIDE ALLERGY10MGTABLET / ORAL2017-12-223f0d92c62455…
2023-05-13 08:27 UTC2023-05A209274-001CETIRIZINE HYDROCHLORIDE ALLERGY10MGTABLET / ORAL2017-12-22053a50430f4f…
2023-01-26 05:58 UTC2023-01A209274-001CETIRIZINE HYDROCHLORIDE ALLERGY10MGTABLET / ORAL2017-12-223bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A209274-001CETIRIZINE HYDROCHLORIDE ALLERGY10MGTABLET / ORAL2017-12-223a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A209274-001CETIRIZINE HYDROCHLORIDE ALLERGY10MGTABLET / ORAL2017-12-22f41ea6bd6efb…

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
Pentrexcilina Day timeCETIRIZINE HYDROCHLORIDEOPMX LLC26f56cb7-be58-a0c2-e063-6294a90a15fa2024-11-15WarningsExact identifier
ndc (package): 69729-137-14
ndc (product): 69729-137
ndc11 (package): 69729013714
spl id: 26f56cb7-be59-a0c2-e063-6294a90a15fa
spl set id: 26f56cb7-be58-a0c2-e063-6294a90a15fa

Reported adverse events (FAERS/openFDA)#

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