Pressure, Pain and Mucus

ACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCL ORAL HUMAN OTC DRUG

Pressure, Pain and Mucus is an FDA drug label for the active ingredient ACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCL manufactured by Meijer Distribution, Inc. 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 20260803.

Generic name
ACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCL
Manufacturer
Meijer Distribution, Inc.
Product type
HUMAN OTC DRUG
Route
ORAL
Dosage form
N/A
NDC
79481-5072
Application
M012
Label effective
20260803

About this product

Pressure, Pain and Mucus is an FDA-registered drug product whose active ingredient is ACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCL. It is labelled by Meijer Distribution, Inc. taken by oral and marketed as a human otc drug product. Identifiers on file: NDC 79481-5072, application M012, label effective 20260803. It is one of 12 FDA drug label records sharing the active ingredient ACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCL. 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, GUAIFENESIN, PHENYLEPHRINE HCL are most often described in connection with: temporarily relieves, symptoms associated, hay fever, respiratory allergies, common cold, headache nasal, congestion minor, pains sinus. Wording differs between labels, and the full indications section on this page takes precedence when it is present.

Active ingredients

Active ingredients (in each caplet) Acetaminophen 325 mg Guaifenesin 200 mg Phenylephrine HCl 5 mg

Indications & Usage

Uses temporarily relieves these symptoms associated with hay fever or other respiratory allergies, and the common cold: headache nasal congestion minor aches and pains sinus congestion and pressure helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive temporarily reduces fever

Dosage & Administration

Directions do not take more than directed adults and children 12 years and over take 2 caplets every 4 hours swallow whole - do not crush, chew, or dissolve do not take more than 10 caplets in 24 hours children under 12 years: ask a doctor

Warnings

Warnings Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take more than 4,000 mg of acetaminophen in 24 hours with other drugs containing acetaminophen 3 or more alcoholic drinks every day while using this product Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include: blisters rash skin reddening If a skin reaction occurs, stop use and seek medical help right away. 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 Ask a doctor before use if you have cough that occurs with too much phlegm (mucus) persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema heart disease thyroid disease diabetes liver disease high blood pressure difficulty in urination due to enlargement of the prostate gland Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin. When using this product do not exceed recommended dosage. Stop use and ask a doctor if nervousness, dizziness, or sleeplessness occur pain, nasal congestion, or cough gets worse or lasts more than 7 days fever gets worse or lasts more than 3 days redness or swelling is present new symptoms occur cough comes back or occurs with rash or headache that lasts. These could be signs of a serious condition. If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children. 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.

More products with the same ingredient

ACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCL

Congestion and Headache

CVS PHARMACY View label

Daytime Sinus Severe

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Head Congestion and Mucus

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Mucus Relief Sinus Severe Congestion and Pain

CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED View label

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Severe Sinus Congestion

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How products containing ACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCL compare

FDA lists 12 drug label records with ACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCL as the active ingredient. The most common dosage forms and the manufacturers with the most records are summarised below; strengths, pack sizes and inactive ingredients can still differ between apparently similar products.

Dosage formProductsManufacturerProducts
— — Meijer Distribution, Inc. 3
— — Better Living Brands, LLC 1
— — CVS PHARMACY 1
— — CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED 1
— — Cardinal Health 110, LLC. DBA Leader 1

Frequently asked questions

What is Pressure, Pain and Mucus used for?
Uses temporarily relieves these symptoms associated with hay fever or other respiratory allergies, and the common cold: headache nasal congestion minor aches and pains sinus congestion and pressure helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive temporarily reduces fever

Who makes Pressure, Pain and Mucus?
Meijer Distribution, Inc. is the labeler of record for Pressure, Pain and Mucus. 12 FDA label records share the active ingredient ACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCL, so generic and branded versions may come from different companies; the manufacturer named on your pack is the one that matters for any enquiry.

What form does Pressure, Pain and Mucus 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 Pressure, Pain and Mucus 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.

Are there other products containing ACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCL?
Yes. 12 FDA drug label records list ACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCL as the active ingredient. Products with the same active ingredient can usually be substituted only when a prescriber or pharmacist confirms it is appropriate.

Has Pressure, Pain and Mucus been recalled?
No FDA recall record in our database matches this product name or manufacturer. Recall data is updated periodically, so a very recent notice may not appear here yet.

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.