Drugplain

Alka-Seltzer Plus Severe Cold Night PowerFast Fizz 325 mg/1

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

No Recall History
Plain English

Alka-Seltzer Plus Severe Cold Night Powerfast Fizz is an over-the-counter medication that combines a pain reliever, decongestant, cough suppressant, and antihistamine to relieve multiple cold and flu symptoms. The effervescent tablet dissolves in water and is designed to provide relief, particularly for nighttime use when symptoms may interfere with sleep.

Key Facts

Brand Name
Alka-Seltzer Plus Severe Cold Night PowerFast Fizz
Generic Name
aspirin, doxylamine succinate, dextromethorphan hydrobromide, phenylephrine bitartrate
NDC Code (Product)
0280-0068
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
07/12/2021

Recall History

No Recall History

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 runny nose sinus congestion and pressure cough sneezing sore throat nasal congestion temporarily reduces fever

Dosage & Administration

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 of age: 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 or any other pain rel

Frequently Asked Questions

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

Alka-Seltzer Plus Severe Cold Night Powerfast Fizz is an over-the-counter medication that combines a pain reliever, decongestant, cough suppressant, and antihistamine to relieve multiple cold and flu symptoms. The effervescent tablet dissolves in water and is designed to provide relief, particularly for nighttime use when symptoms may interfere with sleep.

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

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

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

The generic name for Alka-Seltzer Plus Severe Cold Night PowerFast Fizz is aspirin, doxylamine succinate, dextromethorphan hydrobromide, phenylephrine bitartrate. There are no other listed brand versions of aspirin, doxylamine succinate, dextromethorphan hydrobromide, phenylephrine bitartrate.

What is the NDC code for Alka-Seltzer Plus Severe Cold Night PowerFast Fizz 325 mg/1?

The NDC (National Drug Code) for Alka-Seltzer Plus Severe Cold Night PowerFast Fizz 325 mg/1 is 0280-0068, listed by Bayer HealthCare LLC..

Product NDC

0280-0068

Package NDC

0280-0068-01

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

Data from openFDA · Public domain (CC0 1.0)