Drugplain

Alka-Seltzer Plus Cold and Cough 325 mg/1

Aspirin, Chlorpheniramine maleate, Dextromethorphan hydrobromide, Phenylephrine bitartrate · TABLET, EFFERVESCENT · Bayer HealthCare LLC.

No Recall History
Plain English

Alka-Seltzer Plus Cold and Cough is a prescription tablet, effervescent containing aspirin, chlorpheniramine maleate, dextromethorphan hydrobromide, phenylephrine bitartrate at 325 mg/1, taken oral. Manufactured by Bayer HealthCare LLC..

Key Facts

Brand Name
Alka-Seltzer Plus Cold and Cough
Generic Name
Aspirin, Chlorpheniramine maleate, Dextromethorphan hydrobromide, Phenylephrine bitartrate
NDC Code (Product)
0280-1555
Manufacturer
Bayer HealthCare LLC.
Strength
325 mg/1
Dosage Form
TABLET, EFFERVESCENT
Route
ORAL
Marketing Status
HUMAN OTC DRUG
Application #
M012
Drug Class
Adrenergic alpha1-Agonists [MoA]; Anti-Inflammatory Agents
Marketing Start
09/14/2018

Recall History

No Recall History

Side Effects Reported to FDA

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

drug hypersensitivity4 reports
depression3 reports
dyspnoea3 reports
malaise3 reports
anxiety2 reports
blood glucose increased2 reports
drug ineffective2 reports
exostosis2 reports
feeling abnormal2 reports
foreign body in throat2 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

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

Dosage & Administration

Directions Directions ● adults and children 12 years and over: take 2 tablets fully dissolved in 4 oz of water every 4 hours. Do not exceed 8 tablets in 24 hours or as directed by a doctor. ● children under 12 years: do not use

Warnings

Warnings Reye’s syndrome: Children and teenagers who have or are recovering from chicken pox or flu-like symptoms should not use this product. When using this product, if changes in behavior with nausea and vomiting occur, consult a doctor because these symptoms could be an early sign of Reye’s syndrome, a rare but serious illness. Allergy alert: Aspirin may cause a severe allergic reaction which may include:  hives  facial swelling  asthma (wheezing)  shock Stomach bleeding warning: This product contains an NSAID, which may cause severe stomach bleeding. The chance is higher if you ● are age 60 or older ● have had stomach ulcers or bleeding problems ● take a blood thinning (anticoagulant) or steroid drug ● take other drugs containing prescription or nonprescription NSAIDs (aspirin, ibuprofen, naproxen, or others) ● have 3 or more alcoholic drinks every day while using this product ● take more or for a longer time than directed 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.

Frequently Asked Questions

What is Alka-Seltzer Plus Cold and Cough used for?

Alka-Seltzer Plus Cold and Cough contains Aspirin, Chlorpheniramine maleate, Dextromethorphan hydrobromide, Phenylephrine bitartrate. It is a tablet, effervescent taken oral. Consult your doctor for specific uses.

Is Alka-Seltzer Plus Cold and Cough a controlled substance?

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

What is the generic name for Alka-Seltzer Plus Cold and Cough?

The generic name for Alka-Seltzer Plus Cold and Cough is Aspirin, Chlorpheniramine maleate, Dextromethorphan hydrobromide, Phenylephrine bitartrate. There are 4 other brand versions of Aspirin, Chlorpheniramine maleate, Dextromethorphan hydrobromide, Phenylephrine bitartrate.

What is the NDC code for Alka-Seltzer Plus Cold and Cough 325 mg/1?

The NDC (National Drug Code) for Alka-Seltzer Plus Cold and Cough 325 mg/1 is 0280-1555, listed by Bayer HealthCare LLC..