FDA.reportPublic FDA data

Pentrexcilina - Daytime

Manufacturer
OPMX LLC
Effective date
2026-07-15
Label type
HUMAN OTC DRUG LABEL
Version
6
Source
daily-update
Hydrated at
2026-07-18 05:11:26

Label at a glance#

ProductPentrexcilina Daytime
Active ingredientPHENYLEPHRINE HYDROCHLORIDE, CHLORPHENIRAMINE MALEATE, ACETAMINOPHEN
Label structure14 sections

Storage and handling

Other information: Store at room temperature between 20-25°C (68-77ºF): excursions permitted between 15°C-30°C (59°F-86°F) Avoid excessive heat and humidity Tamper Evident: do not use if package or blister unit is open or shows any sing of tampering

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

ACTIVE INGREDIENTS (in each tablet)

Acetaminophen 500 mg

Chlorpheniramine Maleate 4 mg

Phenylephrine HCl 10 mg

OTC - PURPOSE SECTION

PURPOSE

Pain Reliever/Fever Reducer

Antihistamine

Nasal decongestant

INDICATIONS & USAGE SECTION

Uses:

  • temporarily relieves these symptoms of hay fever or other respiratory allergies:
  • headache
  • sinus congestion & pressure
  • nasal congestion
  • runny nose and sneezing
  • minor aches & pain
  • temporarily relieves these additional symptoms of hay fever:
  • nose or throat itching
  • itchy, watery eyes
  • helps clear nasal passages
  • helps decongest sinus opening and passages

WARNINGS SECTION

Warnings

Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take :

  • more than 6 tablets in 24 hours, which is the maximum daily amount for this product
  • with other drugs contains acetaminophen
  • 3 or more alcoholic drinks every day while using this product.

Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include:

  • skin reddening
  • blisters
  • rash

If a skin reaction occurs, stop use and seek medical help right away.

Sore throat warning: if sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult doctor promptly

OTC - DO NOT USE SECTION

Do not use:

  • with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist
  • 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.
  • if you have ever had an allergic reaction to this product or any of its ingredients
  • to make a child sleepy

OTC - ASK DOCTOR SECTION

Ask a doctor before use if you have:

  • liver disease
  • heart disease
  • high blood pressure
  • thyroid disease
  • glaucoma
  • diabetes
  • trouble urinating due to enlarged prostate gland
  • a breathing problem such as emphysema or chronic bronchitis

OTC - ASK DOCTOR/PHARMACIST SECTION

Ask a doctor or pharmacist before use if you are:

  • taking the blood thinning drug warfarin
  • taking sedatives or tranquilizers

OTC - WHEN USING SECTION

When using this product:

  • do not use more than directed
  • excitability may occur, especially in children
  • drowsiness may occur
  • alcohol, sedatives and tranquilizers may increase drowsiness
  • avoid alcoholic drinks
  • be careful when driving a motor vehicle or operating machinery

OTC - STOP USE SECTION

Stop use and ask a doctor if:

  • nervousness, dizziness, or sleeplessness occur
  • pain or nasal congestion gets worse or lasts more than 7 days
  • fever gets worse or last more than 3 days
  • redness or swelling is present
  • new symptoms occur

These could be signs of a serious condition.

OTC - PREGNANCY OR BREAST FEEDING SECTION

If pregnant or breast-feeding: ask a health professional before use.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

Overdose warning: Taking more than directed can cause serious health problems. 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 for children even if you do not notice any signs or symptoms.

DOSAGE & ADMINISTRATION SECTION

Directions:

  • Do not take more than directed - see overdose warning
  • Swallow whole; do not crush, chew or dissolve
  • Do not exceed 6 tablets per 24 hours
Adults and children 12 years of age & over1 tablet with water every 4-6 hours as needed
Children 4 to 12 years of ageAsk a doctor
Children under 4 years of ageDo not use

STORAGE AND HANDLING SECTION

Other information:

  • Store at room temperature between 20-25°C (68-77ºF): excursions permitted between 15°C-30°C (59°F-86°F)
  • Avoid excessive heat and humidity
  • Tamper Evident: do not use if package or blister unit is open or shows any sing of tampering

INACTIVE INGREDIENT SECTION

Inactive ingredients: Microcrystalline cellulose, Polyvinylpyrrolidone, Crospovidone, Magnesium stearate, Colloidal silicon dioxide, Purified talc

OTC - QUESTIONS SECTION

Questions or comments?

Call: (619) 600-5632 (Mon-Fri 9am-5pm EST) or www.opmx.us

SPL UNCLASSIFIED SECTION

TAMPER EVIDENT: DO NOT USE IF POUCH IS TORN, BROKEN OR SHOWS ANY SIGN OF TAMPERING

Exclusively distributed by:

OPMX

San Diego, CA 92154

Phone: 619-600-5632

PRINCIPAL DISPLAY PANEL - 2 TABLETS

SPL PATIENT PACKAGE INSERT SECTION

NDC 69729-223-02

PENTREXCILINA

Actaminophen 500 mg...........Pain reliever/Fever reducer

Chlorpheniramine Maleate 4 mg.........Antihistamine

Phenylephrine HCl 10 mg..............Nasal decongestant

Effective and Quick Relief from cold & flu symptoms

Headache
Nasal Congestion
Itchy, Watery Eyes
Runny Nose & Sneezing

​

PenDTPouPenDTPou

PRINCIPAL DISPLAY PANEL - 144 TABLETS

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

COLD & FLU

NDC 69729-223-38

DAYTIME

Actaminophen 500 mg • Chlorpheniramine Maleate 4 mg • Phenylephrine HCl 10 mg

PENTREXCILINA

Effective and Quick Relief from cold & flu symptoms

Headache

Nasal Congestion

Itchy, Watery Eyes

Runny Nose & Sneezing​

​144 Tablets (72 Pouches of 2 tablets)

PenDT144PenDT144

PRINCIPAL DISPLAY PANEL - 12 TABLETS

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

COLD & FLU

NDC 69729-223-37

DAYTIME

Actaminophen 500 mg • Chlorpheniramine Maleate 4 mg • Phenylephrine HCl 10 mg

PENTREXCILINA

Effective and Quick Relief from cold & flu symptoms

Headache
Nasal Congestion
Itchy, Watery Eyes
Runny Nose & Sneezing

​12 Tablets (6 Pouches of 2 tablets)

PenDT12PenDT12

PRINCIPAL DISPLAY PANEL - 6 TABLETS

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

COLD & FLU

NDC 69729-223-06

DAYTIME

Actaminophen 500 mg • Chlorpheniramine Maleate 4 mg • Phenylephrine HCl 10 mg

PENTREXCILINA

Effective and Quick Relief from cold & flu symptoms

Headache
Nasal Congestion
Itchy, Watery Eyes
Runny Nose & Sneezing

​6 Tablets (3 Pouches of 2 tablets)

PenDT6PenDT6

PRINCIPAL DISPLAY PANEL 100 TABLETS

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

COLD & FLU

NDC 69729-223-50

DAYTIME

Actaminophen 500 mg • Chlorpheniramine Maleate 4 mg • Phenylephrine HCl 10 mg

PENTREXCILINA®

Effective and Quick Relief from cold & flu symptoms

Headache

Nasal Congestion

Itchy, Watery Eyes

Runny Nose & Sneezing​

​100 Tablets (50 packs of 2 tablets)

PDP100PDP100

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130810053181263GTIN-13: 0810053181263
EAN-13: 0810053181263
GTIN-12: 810053181263
UPC-A: 810053181263
GTIN storage (14 digits): 00810053181263		Pentrexcilina Daytime 6.jpg
BarcodeEAN-130856828008144GTIN-13: 0856828008144
EAN-13: 0856828008144
GTIN-12: 856828008144
UPC-A: 856828008144
GTIN storage (14 digits): 00856828008144		Pentrexcilna Day-Time POUCHE.jpg
BarcodeEAN-130856828008243GTIN-13: 0856828008243
EAN-13: 0856828008243
GTIN-12: 856828008243
UPC-A: 856828008243
GTIN storage (14 digits): 00856828008243		Pentrexcilina DayTime 12.jpg
BarcodeEAN-130856828008250GTIN-13: 0856828008250
EAN-13: 0856828008250
GTIN-12: 856828008250
UPC-A: 856828008250
GTIN storage (14 digits): 00856828008250		Pentrexcilina DayTime 144.jpg, Pntrexcilina Daytime 100 Tablets Box label.jpg
QR code linkQR Codeopmx.us/Pentrexcilina DayTime 144.jpg, Pntrexcilina Daytime 100 Tablets Box label.jpg, Pentrexcilina Daytime 6.jpg, Pentrexcilina DayTime 12.jpg

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
e4e263da-1c53-440f-bb80-b7a575843b5aProduct name120260313
d2168cac-a261-415a-9c78-3522859fa720Product name320251124
05a8cdd1-eeb8-409e-b938-0778225eca7dProduct name420250221
e5b5c132-b15d-435b-9faa-2f74e5cadcf9Product name820250220
f489e8f3-5c9e-4818-b539-a73587edcfc7Product name220240229
0f7ae452-206d-4fc4-868d-56fc47074084Product name120231011
b5abe2e3-39a1-43eb-9bff-f3c1653fe3dfProduct name220190930
d17a97fa-387f-690e-d2be-0083ab044a03Product name320170725
0fdb98e2-b951-a1ce-5715-2b187ba500efProduct name420170718
e0b6c8be-f2bd-9f86-a9fc-3ed56ffaa814Product name320150910
c6fba691-a132-4ede-95c6-f8c6bd696636Product name120150902
c0200ab5-4954-454e-9676-30b741b245bdProduct name120150730
42f3c020-f1b3-89bc-7bdc-e1f10e680485Product name120140508
e949165d-714d-e548-2b76-0cb5def16f30Product name120140508

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
69729-22369729-223-06, 69729-223-38, 69729-223-37, 69729-223-02, 69729-223-50

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
POVIDONE, UNSPECIFIEDFZ989GH94EIACT
CROSPOVIDONE, UNSPECIFIED2S7830E561IACT
PHENYLEPHRINE HYDROCHLORIDE04JA59TNSJACTIB
TALC7SEV7J4R1UIACT
SILICON DIOXIDEETJ7Z6XBU4IACT
MAGNESIUM STEARATE70097M6I30IACT
CHLORPHENIRAMINE MALEATEV1Q0O9OJ9ZACTIB
ACETAMINOPHEN362O9ITL9DACTIB

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
52024-01-26full-release2026-06-01 00:08:13

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 DaytimeACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE HCLOPMX LLCb7b3c15a-bb28-5c25-e053-2a95a90ad3b12026-07-15WarningsExact identifier
ndc (package): 69729-223-02
ndc (package): 69729-223-06
ndc (package): 69729-223-50
ndc (package): 69729-223-38
ndc (package): 69729-223-37
ndc (product): 69729-223
ndc11 (package): 69729022302
ndc11 (package): 69729022306
ndc11 (package): 69729022338
ndc11 (package): 69729022337
ndc11 (package): 69729022350
spl id: 56ab1a6f-9733-820a-e063-6294a90aaa97
spl set id: b7b3c15a-bb28-5c25-e053-2a95a90ad3b1

Reported adverse events (FAERS/openFDA)#

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