PENTREXCILINA

Manufacturer
Healthlife of USA | Vovantis Laboratories Private Limited
Effective date
2023-10-21
Label type
HUMAN OTC DRUG LABEL
Version
8
Source
full-release
Hydrated at
2026-05-31 23:57:08

Label at a glance#

ProductPENTREXCILINA
Active ingredientACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE, DEXTROMETHORPHAN HYDROBROMIDE
Label structure17 sections

Indications and uses

Temporarily Relieves nasal congestion due to the common cold, hay fever or other upper respiratory allergies Relieves sinus congestion and pressure, helps decongest sinus openings and passages Restores freer breathing Helps loosen bothersome mucus, drain bronchial tubes, and make coughs more productive Suppresses cough due to minor throat and bronchial irritation associated with a cold or inhaled irritants Tempora...

Dosage and administration

Adults and children 12 years of age and older: Take 2 tablets every 6 to 8 hours as needed, do not exceed 8 tablets in 24 hours, or as directed by a doctor. Children under 12 years, consult a doctor

Label contents#

Full prescribing information#

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

Active Ingredients (in each tablet)

Acetaminophen USP 325mg.........................................................Pain reliever/fever reducer

Guaifenesin USP 200mg..............................................................Expectorant

Phenylephrine HCL USP 5mg........................................................Decongestant

Dextromethorphan HBr USP 15mg................................................Antitussive

Purpose

OTC - PURPOSE SECTION

Pain reliever/ fever reducer

Expectorant

Decongestant

Antitussive

Uses

INDICATIONS & USAGE SECTION

Temporarily

  • Relieves nasal congestion due to the common cold, hay fever or other upper respiratory allergies
  • Relieves sinus congestion and pressure, helps decongest sinus openings and passages
  • Restores freer breathing
  • Helps loosen bothersome mucus, drain bronchial tubes, and make coughs more productive
  • Suppresses cough due to minor throat and bronchial irritation associated with a cold or inhaled irritants
  • Temporarily relieves minor aches, pains and fever associated with: headache, common cold, toothache, backache, muscular aches, menstrual cramps

Warnings: Liver Warning:

WARNINGS SECTION

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

  • More than 8 tablets in 24 hours
  • With other drugs containing acetaminophen (prescription or nonprescription). Ask a doctor or pharmacist before using with other drugs if you are not sure
  • 3 or more alcoholic drinks every day while using this product

Allergy alert:

OTC - WHEN USING SECTION

Acetaminophen may cause severe skin reactions. Symproms may include: skin reddening, blisters, rash if a skin reaction occurs, stop use and seek medical help right away.

Warning: A persistent cough may be a sign of a serious condition

Do not

OTC - DO NOT USE SECTION

  • use with any other product containing acetaminophen this will provide more than the recommended dose (overdose) of acetaminophen and cold cause serious health concerns.
  • use more than the recommended dose
  • for more than 10 days for pain unless directed by a doctor
  • for more than 3 days for fever unless directed by a doctor
  • when using this product do not exceed recommended dose
  • if you are now taking a presription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping MAOI drug. If you do not know if your prescription drug contains an MAOI, consult a doctor or pharmacist before taking this product
  • take this product for persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema or where cough is accompanied by excessive phlegm (mucus) unless directed by a doctor.

Stop use and ask a doctor if:

OTC - STOP USE SECTION

symptoms do not improve, pain or fever persists or gets worse, new symptoms occur, redness or swelling is present, symptoms do not improve within 7 days or are accompanied by fever, cough persists for more than 1 week, tends to recur, or is accompanied by a fever, rash, or persistent headache. A persistent cough may be a sign of a serious condition

Ask a doctor before use if you have:

OTC - ASK DOCTOR SECTION

heart disease, high blood pressure, thyroid disease, diabetes, difficulty in urination due to enlargement of the prostate gland, liver disease

Ask a doctor or pharmacist if you are

OTC - ASK DOCTOR/PHARMACIST SECTION

taking the blood thinning drug warfarin.

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

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 nnotice any signs or symptoms

Directions:

DOSAGE & ADMINISTRATION SECTION

Adults and children 12 years of age and older: Take 2 tablets every 6 to 8 hours as needed, do not exceed 8 tablets in 24 hours, or as directed by a doctor. Children under 12 years, consult a doctor

Other Inforamtion:

OTC - WHEN USING SECTION

  • Tamper evident. Do not use if packet is torn, cut or opened
  • Store at controlled room temperature 15° to 30°C (59° to 86°F)
  • Avoid excessive heat and humidity

Inactive Ingredients

INACTIVE INGREDIENT SECTION

maltodextrin, microcrystalline cellulose, povidone, silicon dioxide*, sodium starch glycolate, starch, stearic acid

(*may contain)

Questions or comments?

OTC - QUESTIONS SECTION

Call: 619-600-5632 (Mon-Fri 9am - 5pm EST)

Pentrexcilina 2 Tablets in a pouch

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

pentrexcilina-2pentrexcilina-2

pentrexcilina-12-engpentrexcilina-12-eng

pentrexcilina-72pentrexcilina-72

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1367205acetaminophen 325 MG / dextromethorphan HBr 15 MG / phenylephrine HCl 5 MG Oral TabletPSN8
1367205acetaminophen 325 MG / dextromethorphan hydrobromide 15 MG / phenylephrine hydrochloride 5 MG Oral TabletSCD8
1367205APAP 325 MG / dextromethorphan hydrobromide 15 MG / phenylephrine hydrochloride 5 MG Oral TabletSY8

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
DEXTROMETHORPHAN Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813
PHENYLEPHRINE Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

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
e0b6c8be-f2bd-9f86-a9fc-3ed56ffaa814Product name320150910
42f3c020-f1b3-89bc-7bdc-e1f10e680485Product name120140508
e949165d-714d-e548-2b76-0cb5def16f30Product name120140508

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69517-155-06PENTREXCILINA2 in 1 POUCHTABLET28
69517-155-06PENTREXCILINA6 in 1 PACKAGETABLET68
69517-155-72PENTREXCILINA2 in 1 POUCHTABLET28
69517-155-72PENTREXCILINA72 in 1 PACKAGETABLET728

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69517-155PENTREXCILINA (ACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE, DEXTROMETHORPHAN HYDROBROMIDE) TABLET [HEALTHLIFE OF USA]8Current NDC, Legacy NDC, 4 package rows20231021_ae9ada14-0ec8-4c01-a874-237f2108936a.zip

Products#

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

DailyMed product names page 1 of 1 · 14 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
69517-15569517-155-06, 69517-155-72

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 · Source PDF

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
PENTREXCILINAACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE, DEXTROMETHORPHAN HYDROBROMIDEHealthlife of USAae9ada14-0ec8-4c01-a874-237f2108936a2023-10-21WarningsExact identifier
ndc (package): 69517-155-06
ndc (package): 69517-155-72
ndc (product): 69517-155
ndc11 (package): 69517015506
ndc11 (package): 69517015572
spl id: 083396b6-6a36-ffc7-e063-6294a90ad8e2
spl set id: ae9ada14-0ec8-4c01-a874-237f2108936a

Reported adverse events (FAERS/openFDA)#

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