ALKA SELTZER COLD Cold Flu and Congestion Fast Dissolve

CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, ACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE ORAL HUMAN OTC DRUG

ALKA SELTZER COLD Cold Flu and Congestion Fast Dissolve is an FDA drug label for the active ingredient CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, ACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE manufactured by Bayer HealthCare LLC. administered by ORAL. This page reproduces the FDA-approved indications and usage, dosage, contraindications, warnings, and adverse reactions exactly as published in the drug label. Data source: openFDA (U.S. FDA), label effective 20260805.

Generic name
CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, ACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE
Manufacturer
Bayer HealthCare LLC.
Product type
HUMAN OTC DRUG
Route
ORAL
Dosage form
N/A
NDC
0280-8274
Application
M012
Label effective
20260805

About this product

ALKA SELTZER COLD Cold Flu and Congestion Fast Dissolve is an FDA-registered drug product whose active ingredient is CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, ACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE. It is labelled by Bayer HealthCare LLC. taken by oral and marketed as a human otc drug product. Identifiers on file: NDC 0280-8274, application M012, label effective 20260805. 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.

What it is used for

Across FDA labelling, products containing CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, ACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE are most often described in connection with: temporarily relieves, symptoms due, cold flu, minor aches, pains headache, cough sore, throat runny, nose sneezing. Wording differs between labels, and the full indications section on this page takes precedence when it is present.

Active ingredients

Active ingredients (in each tablet) Purposes Acetaminophen 325 mg…………….………...Pain reliever/fever reducer Chlorpheniramine maleate 2 mg……………………..……..Antihistamine Dextromethorphan hydrobromide 10 mg……………Cough suppressant Phenylephrine hydrochloride 5 mg………………….Nasal decongestant

Indications & Usage

Uses temporarily relieves these symptoms due to a cold or flu: minor aches and pains headache cough sore throat runny nose sneezing nasal congestion sinus congestion and pressure temporarily reduces fever

Dosage & Administration

Directions do not take more than the recommended dose adults and children 12 years and over: take 2 tablets fully dissolved in 4 oz of water every 4 hours. Do not exceed 10 tablets in 24 hours or as directed by a doctor. children under 12 years: do not use

Warnings

Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take · more than 10 tablets 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 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 to sedate children. 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 12 years of age Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin taking sedatives or tranquilizers Ask a doctor before use if you have ● liver disease ● heart disease ● high blood pressure ● thyroid disease ● diabetes ● glaucoma ● cough that is accompanied by excessive phlegm (mucus) ● persistent or chronic cough such as occurs with smoking, asthma, or emphysema ● a breathing problem such as emphysema or chronic bronchitis ● difficulty in urination due to enlargement of the prostate gland ● a sodium restricted diet When using this product do not exceed recommended dosage may cause marked drowsiness alcohol, sedatives, and tranquilizers may increase the drowsiness effect avoid alcoholic drinks be careful when driving a motor vehicle or operating machinery excitability may occur, especially in children Stop use and ask a doctor if pain, cough, or nasal congestion 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. nervousness, dizziness, or sleeplessness occurs 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.

Frequently asked questions

What is ALKA SELTZER COLD Cold Flu and Congestion Fast Dissolve used for?
Uses temporarily relieves these symptoms due to a cold or flu: minor aches and pains headache cough sore throat runny nose sneezing nasal congestion sinus congestion and pressure temporarily reduces fever

Who makes ALKA SELTZER COLD Cold Flu and Congestion Fast Dissolve?
Bayer HealthCare LLC. is the labeler of record for ALKA SELTZER COLD Cold Flu and Congestion Fast Dissolve.

What form does ALKA SELTZER COLD Cold Flu and Congestion Fast Dissolve 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 Flu and Congestion Fast Dissolve 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 ALKA SELTZER COLD Cold Flu and Congestion Fast Dissolve 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.

This page reproduces FDA Structured Product Labelling data for identification and reference. It is not medical advice, does not diagnose or treat any condition, and does not sell or price any medicine.