Maximum Strength Mucus Relief Plus Pain and Headache

Maximum Strength Mucus Relief Plus Pain and Headache is an FDA-registered drug product whose active ingredient is ACETAMINOPHEN, GUAIFENESIN. It is labelled by Shield Pharmaceuticals Corp taken by oral and marketed as a human otc drug product. Identifiers on file: NDC 83059-0052, application M012, label effective 20260506. It is one of 4 FDA drug label records sharing the active ingredient ACETAMINOPHEN, GUAIFENESIN. 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.

Across FDA labelling, products containing ACETAMINOPHEN, GUAIFENESIN are most often described in connection with: temporarily relieves, common cold, flu symptoms, minor aches, pains headache, sore throat, helps loosen, phlegm mucus. Wording differs between labels, and the full indications section on this page takes precedence when it is present.

Uses temporarily relieves these common cold and flu symptoms: minor aches and pains headache sore throat helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive temporarily reduces fever

Directions do not take more than directed (see Overdose warning) do not take more than 12 softgels in any 24-hour period adults and children 12 years of age and over: take 2 softgels every 4 hours children under 12 years of age: do not use

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 produc t 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. Ask a doctor before use if you have liver disease 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 pain 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.

FDA lists 4 drug label records with ACETAMINOPHEN, GUAIFENESIN 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.

What is Maximum Strength Mucus Relief Plus Pain and Headache used for?
Uses temporarily relieves these common cold and flu symptoms: minor aches and pains headache sore throat helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive temporarily reduces fever

Who makes Maximum Strength Mucus Relief Plus Pain and Headache?
Shield Pharmaceuticals Corp is the labeler of record for Maximum Strength Mucus Relief Plus Pain and Headache. 4 FDA label records share the active ingredient ACETAMINOPHEN, GUAIFENESIN, 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 Maximum Strength Mucus Relief Plus Pain and Headache 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 Plus Pain and Headache 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?
Yes. 4 FDA drug label records list ACETAMINOPHEN, GUAIFENESIN 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 Maximum Strength Mucus Relief Plus Pain and Headache 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.