ALKA SELTZER COLD Cold and Cough Fast

ALKA SELTZER COLD Cold and Cough Fast is an FDA-registered drug product whose active ingredient is ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE. It is labelled by Bayer HealthCare LLC. taken by oral and marketed as a human otc drug product. Identifiers on file: NDC 0280-8279, application M012, label effective 20260520. It is one of 16 FDA drug label records sharing the active ingredient ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE. 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 HYDROBROMIDE are most often described in connection with: temporarily relieves, symptoms due, cold flu, minor aches, pains headache, cough sore, reduces fever. Wording differs between labels, and the full indications section on this page takes precedence when it is present.

Uses · temporarily relieves these symptoms due to a cold or flu: · minor aches and pains · headache · cough · sore throat · temporarily reduces fever

Directions Directions · do not take more than the recommended dose · adults and children 12 years and over: take 2 tablets every 4 hours. Do not exceed 6 doses (12 tablets) tablets in 24 hours or as directed by a doctor. · children 6 to under 12 years: take 2 tablets every 4 hours. Do not exceed 5 doses (10 tablets) in 24 hours or as directed by a doctor. · do not swallow tablets whole. Chew or crush tablets completely before swallowing. · children under 12 years: do not use

Warnings Liver warning: This product contains acetaminophen. Severe liver damage may occur if · adult takes more than 12 tablets in 24 hours. which is the maximum daily amount for this product · child takes more than 5 doses in 24hours · taken with other drugs containing acetaminophen · adult has 3 or more alcoholic drinks every day while using this product Allergy alert: Acetaminophen may cause severe skin or severe allergic reactions. Symptoms may include: · skin reddening · blisters · rash · hives · facial swelling · asthma (wheezing) · shock If a skin or general allergic 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. ● 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. ● if you have ever had an allergic reaction to this product or any of its ingredients ● in children under 6 years of age Ask a doctor before use if you have ● liver disease ● cough that is accompanied by excessive phlegm (mucus) ● persistent or chronic cough such as occurs with smoking, asthma, or emphysema ● a sodium restricted diet Ask a doctor or pharmacist before use if the user is taking the blood thinning drug warfarin Stop use and ask a doctor if · pain or cough gets worse or lasts more than 5 days (children) or 7 days (adults) · 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. If pregnant or breast-feeding , ask a health professional before use. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms

FDA lists 16 drug label records with ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE 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 ALKA SELTZER COLD Cold and Cough Fast used for?
Uses · temporarily relieves these symptoms due to a cold or flu: · minor aches and pains · headache · cough · sore throat · temporarily reduces fever

Who makes ALKA SELTZER COLD Cold and Cough Fast?
Bayer HealthCare LLC. is the labeler of record for ALKA SELTZER COLD Cold and Cough Fast. 16 FDA label records share the active ingredient ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, 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 ALKA SELTZER COLD Cold and Cough Fast 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 ALKA SELTZER COLD Cold and Cough Fast 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 HYDROBROMIDE?
Yes. 16 FDA drug label records list ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE 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 ALKA SELTZER COLD Cold and Cough Fast 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.