Drugplain

Alka-Seltzer Plus Severe Cold Powerfast Fizz Night 500 mg/1

aspirin, dextromethorphan hydrobromide, doxylamine succinate, phenylephrine bitartrate · TABLET, EFFERVESCENT · Bayer HealthCare LLC.

No Recall History
Plain English

Alka-Seltzer Plus Severe Cold Powerfast Fizz Night is a tablet, effervescent containing aspirin, dextromethorphan hydrobromide, doxylamine succinate, phenylephrine bitartrate at 500 mg/1, taken oral. Manufactured by Bayer HealthCare LLC..

Key Facts

Brand Name
Alka-Seltzer Plus Severe Cold Powerfast Fizz Night
Generic Name
aspirin, dextromethorphan hydrobromide, doxylamine succinate, phenylephrine bitartrate
NDC Code (Product)
0280-0021
Manufacturer
Bayer HealthCare LLC.
Strength
500 mg/1
Dosage Form
TABLET, EFFERVESCENT
Route
ORAL
Marketing Status
Application #
M012
Drug Class
Nonsteroidal Anti-inflammatory Drug [EPC]; Platelet Aggregation Inhibitor [EPC]
Marketing Start
04/01/2020

Recall History

No Recall History

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

Uses Uses ● temporarily relieves these symptoms due to a cold: ● minor aches and pains ● headache ● runny nose ● sinus congestion and pressure ● cough ● sneezing ● sore throat ● nasal congestion ● 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 6 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. Do not use ● if you are allergic to aspirin

Frequently Asked Questions

What is Alka-Seltzer Plus Severe Cold Powerfast Fizz Night used for?

Alka-Seltzer Plus Severe Cold Powerfast Fizz Night contains aspirin, dextromethorphan hydrobromide, doxylamine succinate, phenylephrine bitartrate. It is a tablet, effervescent taken oral. Consult your doctor for specific uses.

Is Alka-Seltzer Plus Severe Cold Powerfast Fizz Night a controlled substance?

Alka-Seltzer Plus Severe Cold Powerfast Fizz Night is not classified as a controlled substance by the DEA.

What is the generic name for Alka-Seltzer Plus Severe Cold Powerfast Fizz Night?

The generic name for Alka-Seltzer Plus Severe Cold Powerfast Fizz Night is aspirin, dextromethorphan hydrobromide, doxylamine succinate, phenylephrine bitartrate. There are 1 other brand versions of aspirin, dextromethorphan hydrobromide, doxylamine succinate, phenylephrine bitartrate.

What is the NDC code for Alka-Seltzer Plus Severe Cold Powerfast Fizz Night 500 mg/1?

The NDC (National Drug Code) for Alka-Seltzer Plus Severe Cold Powerfast Fizz Night 500 mg/1 is 0280-0021, listed by Bayer HealthCare LLC..

Product NDC

0280-0021

Package NDC

0280-0021-01

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

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