Pentrexcilina Severe Allergy

Manufacturer
OPMX LLC | Health Pharma USA LLC
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 Severe Allergy
Active ingredientDIPHENHYDRAMINE 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 itchy nose or throat temporarily relieves these symptoms of the common cold

Dosage and administration

take every 4 to 6 hours, or as directed by a doctor do not take more than 6 doses in 24 hours ​Adults and children 12 years and over: 1 or 2 caplets Children 6 to under 12 years of age: 1 caplet Children under 6 years of age: do not use

Storage and handling

Each caplet contains: Calcium 23.52 mg store at controlled room temperature 20°-25°C (68°-77°F). read all product information before using 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 (in each tablet)

OTC - ACTIVE INGREDIENT SECTION

Diphenhydramine HCl 25mg

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
  • itchy nose or throat
  • temporarily relieves these symptoms of the
  • common cold

Warnings

WARNINGS SECTION

Do not use

OTC - DO NOT USE SECTION

  • with any other product containing dyphenhydramine, even one used on skin
  • to make a child sleepy

ask a doctor before use if you have

OTC - ASK DOCTOR SECTION

  • trouble urinating due to an enlarged prostate gland
  • a breathing problem such as emphysema or chronic bronchitis

ask your doctor or pharmacist before use if you are

OTC - ASK DOCTOR/PHARMACIST SECTION

  • taking sedative or tranquilizers

When using this product

OTC - WHEN USING SECTION

  • marked drowsiness may occur
  • avoid alcoholic drinks
  • excitability may occur, especially in children
  • alcohol, sedatives and tranquilizers may increase drowsiness
  • be careful when driving a motor vehicle or operating machinery

If pregnant or breast-feeding,

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a professional before use

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

  • take every 4 to 6 hours, or as directed by a doctor
  • do not take more than 6 doses in 24 hours

​Adults and children 12 years and over: 1 or 2 caplets

Children 6 to under 12 years of age: 1 caplet

Children under 6 years of age: do not use

Other information

STORAGE AND HANDLING SECTION

  • Each caplet contains: Calcium 23.52 mg
  • store at controlled room temperature 20°-25°C (68°-77°F).
  • read all product information before using

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

Inactive ingredients

INACTIVE INGREDIENT SECTION

Colloidal silicon Dioxide, Croscarmellose Sodium, D & C Red #27, Dicalcium Phosphate, Lecithin, Magnesium stearate, Microcrystalline cellulose, Polyvinyl alcohol, Titanium dioxide, Talc.

Questions or comments?

OTC - QUESTIONS SECTION

Call (619) 600-5632

Monday through Friday 9AM- 5PM EST

Principal display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Night timeNight time

Pentrexcilina 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
1049630diphenhydrAMINE HCl 25 MG Oral TabletPSN1
1049630diphenhydramine hydrochloride 25 MG Oral TabletSCD1

DailyMed Pharmacologic Classes#

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

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
0e2e0f88-b076-afe1-4bdd-32bca4375becProduct name320250127
3e48c9c4-918d-5d23-2f0b-d2398b06be54Product name120140508
865c72dd-0d94-daac-f728-ddd4ded2a79eProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
69729-106-142025-07-29C16284748780-13b156c62-2c53-fb37-e063-e6dba90a4e07Pentrexcilina Night Time

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69729-106-14Pentrexcilina Severe Allergy14 in 1 BOTTLETABLET, FILM COATED141

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69729-106PENTREXCILINA SEVERE ALLERGY (DIPHENHYDRAMINE HYDROCHLORIDE) TABLET, FILM COATED [OPMX LLC]11 package rows20241121_26fb4060-70bd-d5b9-e063-6294a90ad2bd.zip

Products#

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

DailyMed product names page 1 of 1 · 13 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
69729-10669729-106-14

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 11 matching rows.

Source Document#

Source XML

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
26fb4060-70be-d5b9-e063-6294a90ad2bd26fb4060-70bd-d5b9-e063-6294a90ad2bd2024-11-15WarningsExact identifier
spl id: 26fb4060-70be-d5b9-e063-6294a90ad2bd
spl set id: 26fb4060-70bd-d5b9-e063-6294a90ad2bd

Reported adverse events (FAERS/openFDA)#

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