Maximum Strength Mucus Relief Cold,Flu and Sore Throat

ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN ,PHENYLEPHRINE HCL ORAL HUMAN OTC DRUG

Maximum Strength Mucus Relief Cold,Flu and Sore Throat is an FDA drug label for the active ingredient ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN ,PHENYLEPHRINE HCL manufactured by SUPERVALU 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 20170901.

Generic name
ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN ,PHENYLEPHRINE HCL
Manufacturer
SUPERVALU INC
Product type
HUMAN OTC DRUG
Route
ORAL
Dosage form
N/A
NDC
41163-737
Application
part341
Label effective
20170901

About this product

Maximum Strength Mucus Relief Cold,Flu and Sore Throat is an FDA-registered drug product whose active ingredient is ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN ,PHENYLEPHRINE HCL. It is labelled by SUPERVALU INC taken by oral and marketed as a human otc drug product. Identifiers on file: NDC 41163-737, application part341, label effective 20170901. 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, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN ,PHENYLEPHRINE HCL are most often described in connection with: temporarily relieves, common cold, flu symptoms, nasal congestion, pressure cough, due minor, bronchial irritation, pains sore. Wording differs between labels, and the full indications section on this page takes precedence when it is present.

Active ingredients

Active ingredients (in each 20 mL) Purposes Acetaminophen 650 mg Pain reliever/fever reducer Dextromethorphan HBr 20 mg Cough suppressant Guaifenesin 400 mg Expectorant Phenylephrine HCl 10 mg Nasal decongestant

Indications & Usage

Uses • temporarily relieves these common cold and flu symptoms: • nasal congestion • sinus congestion and pressure • cough due to minor throat and bronchial irritation • minor aches and pains • sore throat • headache • temporarily reduces fever • temporarily promotes nasal and/or sinus drainage • helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive

Dosage & Administration

Directions • do not take more than directed (see Overdose Warning) ) • do not take more than 6 doses in any 24-hour period • measure only with dosing cup provided • do not use dosing cup with other products • dose as follows or as directed by a doctor • mL= milliliter • Adults and children 12 years of age and older: 20 mL in dosing cup provided every 4 hours • Children under 12 years of age: Do not use

Warnings

Warnings Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take: • more than 6 doses in 24 hours, which is the maximum daily amount • with other drugs containing acetaminophen • 3 or more alcoholic drinks daily 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 a doctor promptly. 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. • for children under 12 years of age • 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. Ask a doctor before use if you have • liver disease • heart disease • high blood pressure • thyroid disease • diabetes • trouble urinating due to an enlarged prostate gland • persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema • cough that occurs with too much phlegm (mucus) Ask a doctor or pharmacist before use if • you are taking the blood thinning drug warfarin When using this product • do not use more than directed 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 persistent headache. 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.

Adverse Reactions

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.

Frequently asked questions

What is Maximum Strength Mucus Relief Cold,Flu and Sore Throat used for?
Uses • temporarily relieves these common cold and flu symptoms: • nasal congestion • sinus congestion and pressure • cough due to minor throat and bronchial irritation • minor aches and pains • sore throat • headache • temporarily reduces fever • temporarily promotes nasal and/or sinus drainage • helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of …

Who makes Maximum Strength Mucus Relief Cold,Flu and Sore Throat?
SUPERVALU INC is the labeler of record for Maximum Strength Mucus Relief Cold,Flu and Sore Throat.

What form does Maximum Strength Mucus Relief Cold,Flu and Sore Throat 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 Maximum Strength Mucus Relief Cold,Flu and Sore Throat 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 Maximum Strength Mucus Relief Cold,Flu and Sore Throat 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.