PENTREXCILINA
PENTREXCILINA is an FDA drug label for the active ingredient ACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE, DEXTROMETHORPHAN HYDROBROMIDE manufactured by Healthlife of USA administered by ORAL. This page reproduces the FDA-approved indications and usage, dosage, contraindications, warnings, and adverse reactions exactly as published in the drug label. Data source: openFDA (U.S. FDA), label effective 20231021.
- Generic name
- ACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE, DEXTROMETHORPHAN HYDROBROMIDE
- Manufacturer
- Healthlife of USA
- Product type
- HUMAN OTC DRUG
- Route
- ORAL
- Dosage form
- N/A
- NDC
- 69517-155
- Application
- M012
- Label effective
- 20231021
About this product
PENTREXCILINA is an FDA-registered drug product whose active ingredient is ACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE, DEXTROMETHORPHAN HYDROBROMIDE. It is labelled by Healthlife of USA taken by oral and marketed as a human otc drug product. Identifiers on file: NDC 69517-155, application M012, label effective 20231021. This page reproduces the FDA-approved label text so you can check what a product is, who makes it and how it is supplied before discussing it with a pharmacist or prescriber.
What it is used for
Across FDA labelling, products containing ACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE, DEXTROMETHORPHAN HYDROBROMIDE are most often described in connection with: temporarily relieves, common cold, nasal congestion, hay fever, upper respiratory, pressure helps, decongest sinus, passages restores. Wording differs between labels, and the full indications section on this page takes precedence when it is present.
Active ingredients
Indications & Usage
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 Temporarily relieves minor aches, pains and fever associated with: headache, common cold, toothache, backache, muscular aches, menstrual cramps
Dosage & Administration
Directions: 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
Warnings
Warnings: Liver Warning: 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
Recall and safety notices
2 FDA recall record(s) match this product name or manufacturer. A match means the firm or product name appears in the enforcement report; confirm lot numbers and dates against the official FDA notice before acting.
| Recall | Product | Firm | Class | Status | Reported |
|---|---|---|---|---|---|
| D-300-2013 | Pentrexcilina Jarabe NF (dextromethorphan HBr and guaifenesin) liquid, 118 mL/ 4 fl oz bottle, Distributed by Laboratorios Nordimex Co., San Diego, CA 92154, UPC 0 91965 02001 1. | OPMX, LLC | Class II | Terminated | 20130501 |
| D-299-2013 | Pentrexcilina (acetaminophen, chlorpheniramine maleate, and phenylephrine HCl) tablets, 20-count tablets per carton, Distributed by: Laboratorios Norimex Co., San Diego, CA 92154, UPC 0 91965 02002 8. | OPMX, LLC | Class II | Terminated | 20130501 |
Frequently asked questions
What is PENTREXCILINA used for?
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 …
Who makes PENTREXCILINA?
Healthlife of USA is the labeler of record for PENTREXCILINA.
What form does PENTREXCILINA come in?
administered by oral. Strengths and pack sizes vary by label, so compare the NDC on your pack with the identifier listed on this page.
Is PENTREXCILINA prescription or over-the-counter?
The FDA label for this product is recorded as human otc drug. Marketing status can differ between strengths and countries, so check the dispensing rules where you live.
Has PENTREXCILINA been recalled?
2 FDA recall record(s) match this product name or manufacturer. Review the recall and safety notices section on this page and confirm lot numbers against the official FDA enforcement report.
Where does this information come from?
All content is reproduced from FDA Structured Product Labelling data via openFDA. It is provided for identification and reference only and is not medical advice.
This page reproduces FDA Structured Product Labelling data for identification and reference. It is not medical advice, does not diagnose or treat any condition, and does not sell or price any medicine.