Cold and Sinus Maxium Strength

Cold and Sinus Maxium Strength is an FDA-registered drug product whose active ingredient is ACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE. It is labelled by DeMoulas Market Basket taken by oral and marketed as a human otc drug product. Identifiers on file: NDC 53942-515, application M012, label effective 20231229. It is one of 3 FDA drug label records sharing the active ingredient ACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE. 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, PHENYLEPHRINE HYDROCHLORIDE are most often described in connection with: temporarily relieves, common cold, flu symptoms, nasal congestion, pressure minor, pains sore, throat headache, fever helps. 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: nasal congestion sinus congestion and pressure minor aches and pains sore throat headache fever helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes

Directions take only as recommended (see Overdose warning) use dosage cup mL = milliliter do not take more han 6 doses in any 24-hour period Age Dose Adults & children 20 mL every 4 hours 12 years and older Children under 12 Do not use years of age

Warnings Liver warning This product contains acetamnophen. 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: 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.

FDA lists 3 drug label records with ACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE 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 Cold and Sinus Maxium Strength used for?
Uses temporarily relieves these common cold and flu symptoms: nasal congestion sinus congestion and pressure minor aches and pains sore throat headache fever helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes

Who makes Cold and Sinus Maxium Strength?
DeMoulas Market Basket is the labeler of record for Cold and Sinus Maxium Strength. 3 FDA label records share the active ingredient ACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE, 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 Cold and Sinus Maxium Strength 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 Cold and Sinus Maxium Strength 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 HYDROCHLORIDE?
Yes. 3 FDA drug label records list ACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE 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 Cold and Sinus Maxium Strength 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.