Alka-Seltzer Plus Day Severe Cold Plus Flu 500 mg/1

ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, and PHENYLEPHRINE HYDROCHLORIDE · POWDER, FOR SOLUTION · Bayer HealthCare LLC.

No Recall HistoryCurrently in Shortage

Plain English

Alka-Seltzer Plus Day Severe Cold Plus Flu is a prescription powder, for solution containing acetaminophen, dextromethorphan hydrobromide, guaifenesin, and phenylephrine hydrochloride at 500 mg/1, taken oral. Manufactured by Bayer HealthCare LLC..

Key Facts

Brand Name: Alka-Seltzer Plus Day Severe Cold Plus Flu
Generic Name: ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, and PHENYLEPHRINE HYDROCHLORIDE
NDC Code (Product): 0280-0921
Manufacturer: Bayer HealthCare LLC.
Strength: 500 mg/1
Dosage Form: POWDER, FOR SOLUTION
Route: ORAL
Marketing Status: HUMAN OTC DRUG
Application #: M012
Drug Class: Adrenergic alpha1-Agonists [MoA]; Decreased Respiratory Secretion Viscosity [PE]
Marketing Start: 04/17/2014

Recall History

No Recall History

Side Effects Reported to FDA

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

drug ineffective2 reports

blood glucose increased1 reports

deafness1 reports

expired product administered1 reports

hypoacusis1 reports

therapeutic product effect delayed1 reports

tinnitus1 reports

wrong technique in product usage process1 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

Uses temporarily relieves these symptoms due to a cold or flu: minor aches and pains headache sore throat cough nasal congestion sinus congestion and pressure helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus temporarily reduces fever

Dosage & Administration

Directions do not take more than the recommended dose take every 4 hours; do not exceed 6 packets in 24 hours or as directed by a doctor adults and children 12 years and over: dissolve contents of one packet in 8 oz. hot water; sip while hot. Consume entire drink within 10-15 minutes. children under 12 years: do not use

Warnings

Warnings Liver warning This product contains acetaminophen. Severe liver damage may occur if you take more than 6 packets 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. 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 before use if you have liver disease heart disease high blood pressure thyroid disease diabete…

Frequently Asked Questions

What is Alka-Seltzer Plus Day Severe Cold Plus Flu used for?

Alka-Seltzer Plus Day Severe Cold Plus Flu contains ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, and PHENYLEPHRINE HYDROCHLORIDE. It is a powder, for solution taken oral. Consult your doctor for specific uses.

Is Alka-Seltzer Plus Day Severe Cold Plus Flu a controlled substance?

Alka-Seltzer Plus Day Severe Cold Plus Flu is not classified as a controlled substance by the DEA.

What is the generic name for Alka-Seltzer Plus Day Severe Cold Plus Flu?

The generic name for Alka-Seltzer Plus Day Severe Cold Plus Flu is ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, and PHENYLEPHRINE HYDROCHLORIDE. There are 12 other brand versions of ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, and PHENYLEPHRINE HYDROCHLORIDE.

What is the NDC code for Alka-Seltzer Plus Day Severe Cold Plus Flu 500 mg/1?

The NDC (National Drug Code) for Alka-Seltzer Plus Day Severe Cold Plus Flu 500 mg/1 is 0280-0921, listed by Bayer HealthCare LLC..

Product NDC

0280-0921

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Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.

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