Acetaminophen, Dextromethorphan HBr ,Guaifenesin

Acetaminophen, Dextromethorphan HBr ,Guaifenesin is an FDA-registered drug product whose active ingredient is ACETAMINOPHEN, DEXTROMETHORPHAN HBR ,GUAIFENESIN. It is labelled by Softgel Healthcare Pvt Ltd taken by oral and marketed as a human otc drug product. Identifiers on file: NDC 35916-0184, application M012, label effective 20260427. 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, DEXTROMETHORPHAN HBR ,GUAIFENESIN are most often described in connection with: temporarily relieves, common cold, flu symptoms, cough due, minor throat, bronchial irritation, aches pains, headache fever. Wording differs between labels, and the full indications section on this page takes precedence when it is present.

Uses temporarily relieves common cold/flu symptoms: cough due to minor throat & bronchial irritation minor aches & pains headache fever sore throat helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passage ways of bothersome mucus and make coughs more productive.

Directions take only as directed do not exceed 8 softgels per 24 hrs adults & children 12 years & over 2 softgels with water every 4 hours children 4 to under 12 years ask a doctor children under 4 years do not use

Warnings Liver warning: This product contains acetaminophen.Severe liver damage may occur if you take more than 8 softgels in 24 hrs, which is the maximum daily amount for this product 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.

What is Acetaminophen, Dextromethorphan HBr ,Guaifenesin used for?
Uses temporarily relieves common cold/flu symptoms: cough due to minor throat & bronchial irritation minor aches & pains headache fever sore throat helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passage ways of bothersome mucus and make coughs more productive.

Who makes Acetaminophen, Dextromethorphan HBr ,Guaifenesin?
Softgel Healthcare Pvt Ltd is the labeler of record for Acetaminophen, Dextromethorphan HBr ,Guaifenesin.

What form does Acetaminophen, Dextromethorphan HBr ,Guaifenesin 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 Acetaminophen, Dextromethorphan HBr ,Guaifenesin 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 Acetaminophen, Dextromethorphan HBr ,Guaifenesin 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.