Drugplain

Alka-Seltzer Plus Cough and Sore Throat FizzyChews 162.5 mg/1

acetaminophen, dextromethorphan hydrobromide · TABLET, CHEWABLE · Bayer HealthCare LLC.

No Recall HistoryCurrently in Shortage
Plain English

Alka-Seltzer Plus Cough and Sore Throat FizzyChews is a prescription tablet, chewable containing acetaminophen, dextromethorphan hydrobromide at 162.5 mg/1, taken oral. Manufactured by Bayer HealthCare LLC..

Key Facts

Brand Name
Alka-Seltzer Plus Cough and Sore Throat FizzyChews
Generic Name
acetaminophen, dextromethorphan hydrobromide
NDC Code (Product)
0280-0152
Manufacturer
Bayer HealthCare LLC.
Strength
162.5 mg/1
Dosage Form
TABLET, CHEWABLE
Route
ORAL
Marketing Status
HUMAN OTC DRUG
Application #
M012
Drug Class
Sigma-1 Agonist [EPC]; Sigma-1 Receptor Agonists [MoA]
Marketing Start
04/01/2024

Recall History

No Recall History

Side Effects Reported to FDA

FDA FAERS database · These are reported events, not confirmed side effects

asthenopia1 reports
epistaxis1 reports
feeling abnormal1 reports
incorrect dose administered1 reports
mouth ulceration1 reports
oral herpes1 reports
poor quality product administered1 reports
product complaint1 reports
somnolence1 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

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

Dosage & Administration

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

Warnings Liver warning: This product contains acetaminophen. Severe liver damage may occur if · adult takes more than 4,000 mg of acetaminophen in 24 hours · 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 y

Frequently Asked Questions

What is Alka-Seltzer Plus Cough and Sore Throat FizzyChews used for?

Alka-Seltzer Plus Cough and Sore Throat FizzyChews contains acetaminophen, dextromethorphan hydrobromide. It is a tablet, chewable taken oral. Consult your doctor for specific uses.

Is Alka-Seltzer Plus Cough and Sore Throat FizzyChews a controlled substance?

Alka-Seltzer Plus Cough and Sore Throat FizzyChews is not classified as a controlled substance by the DEA.

What is the generic name for Alka-Seltzer Plus Cough and Sore Throat FizzyChews?

The generic name for Alka-Seltzer Plus Cough and Sore Throat FizzyChews is acetaminophen, dextromethorphan hydrobromide. There are 12 other brand versions of acetaminophen, dextromethorphan hydrobromide.

What is the NDC code for Alka-Seltzer Plus Cough and Sore Throat FizzyChews 162.5 mg/1?

The NDC (National Drug Code) for Alka-Seltzer Plus Cough and Sore Throat FizzyChews 162.5 mg/1 is 0280-0152, listed by Bayer HealthCare LLC..