Acetaminophen, Dextromethorphan HBr

Acetaminophen, Dextromethorphan HBr is an FDA-registered drug product whose active ingredient is ACETAMINOPHEN, DEXTROMETHORPHAN HBR. It is labelled by NUVICARE LLC taken by oral and marketed as a human otc drug product. Identifiers on file: NDC 84324-036, application M012, label effective 20260806. It is one of 15 FDA drug label records sharing the active ingredient ACETAMINOPHEN, DEXTROMETHORPHAN HBR. 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 are most often described in connection with: temporarily relieves, common cold, flu symptoms, minor aches, pains headache, sore throat, fever cough, bronchial irritation. Wording differs between labels, and the full indications section on this page takes precedence when it is present.

Uses Temporarily relieves common cold and flu symptoms: • Minor aches and pains • Headache • Sore throat • Fever • Cough due to minor throat and bronchial irritation

Directions Take only as directed-see OVERDOSE WARNING. Do not exceed 8 softgels per 24 hours. Adults & children 12 years and over Take 2 softgels with water every 4 hours Children 4 to under 12 years Ask a doctor Children under 4 years Do not use

Warnings 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. Liver warning This product contains acetaminophen. Severe liver damage may occur if you take: • More than 8 softgels in 24 hours, 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 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 15 drug label records with ACETAMINOPHEN, DEXTROMETHORPHAN HBR 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.

1 FDA recall record(s) match this product name or manufacturer. A match means the firm or product name appears in the enforcement report; confirm lot numbers and dates against the official FDA notice before acting.

What is Acetaminophen, Dextromethorphan HBr used for?
Uses Temporarily relieves common cold and flu symptoms: • Minor aches and pains • Headache • Sore throat • Fever • Cough due to minor throat and bronchial irritation

Who makes Acetaminophen, Dextromethorphan HBr?
NUVICARE LLC is the labeler of record for Acetaminophen, Dextromethorphan HBr. 15 FDA label records share the active ingredient ACETAMINOPHEN, DEXTROMETHORPHAN HBR, 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 Acetaminophen, Dextromethorphan HBr 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 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, DEXTROMETHORPHAN HBR?
Yes. 15 FDA drug label records list ACETAMINOPHEN, DEXTROMETHORPHAN HBR 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 Acetaminophen, Dextromethorphan HBr been recalled?
1 FDA recall record(s) match this product name or manufacturer. Review the recall and safety notices section on this page and confirm lot numbers against the official FDA enforcement report.

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.