Drugplain

Alka-Seltzer Original 1000 mg/1

ANHYDROUS CITRIC ACID, ASPIRIN, and SODIUM BICARBONATE · TABLET, EFFERVESCENT · Bayer HealthCare LLC.

1 Recall on RecordCurrently in Shortage
Plain English

Alka-Seltzer Original is an over-the-counter effervescent tablet containing aspirin, sodium bicarbonate, and citric acid that you dissolve in water and take by mouth to relieve heartburn, acid indigestion, and upset stomach. The aspirin also provides pain relief, while the sodium bicarbonate works to neutralize stomach acid.

Key Facts

Brand Name
Alka-Seltzer Original
Generic Name
ANHYDROUS CITRIC ACID, ASPIRIN, and SODIUM BICARBONATE
NDC Code (Product)
0280-4000
Manufacturer
Bayer HealthCare LLC.
Strength
1000 mg/1
Dosage Form
TABLET, EFFERVESCENT
Route
ORAL
Marketing Status
Application #
M013
Drug Class
Calculi Dissolution Agent [EPC]; Anti-coagulant [EPC]
Marketing Start
03/02/2010

Recall History

1 Recall on Record
Class II03/30/2017

Bayer HealthCare Pharmaceuticals, Inc.

Defective Container: Confirmed customer compliant of small holes or cracks in the foil of blister packs.

TerminatedVoluntary: Firm initiated

Side Effects Reported to FDA

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

product use issue52 reports
drug dependence40 reports
therapeutic response unexpected23 reports
drug ineffective19 reports
dyspnoea17 reports
incorrect drug administration duration17 reports
death15 reports
off label use15 reports
choking14 reports
myocardial infarction14 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

Uses ● temporarily relieves minor aches and pains due to: ● headache ● muscle pain ● backache ● toothache ● menstrual pain ● colds ● minor pain of arthritis ● temporarily reduces fever

Dosage & Administration

Directions ● fully dissolve 2 tablets in 4 ounces of water before taking adults and children 12 years and over 2 tablets every 4 hours, or as directed by a doctor do not exceed 8 tablets in 24 hours adults 60 years and over 2 tablets every 4 hours, or as directed by a doctor do not exceed 4 tablets in 24 hours children under 12 years consult a doctor

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

Frequently Asked Questions

What is Alka-Seltzer Original used for?

Alka-Seltzer Original is an over-the-counter effervescent tablet containing aspirin, sodium bicarbonate, and citric acid that you dissolve in water and take by mouth to relieve heartburn, acid indigestion, and upset stomach. The aspirin also provides pain relief, while the sodium bicarbonate works to neutralize stomach acid.

Is Alka-Seltzer Original a controlled substance?

Alka-Seltzer Original is not classified as a controlled substance by the DEA.

What is the generic name for Alka-Seltzer Original?

The generic name for Alka-Seltzer Original is ANHYDROUS CITRIC ACID, ASPIRIN, and SODIUM BICARBONATE. There are 3 other brand versions of ANHYDROUS CITRIC ACID, ASPIRIN, and SODIUM BICARBONATE.

What is the NDC code for Alka-Seltzer Original 1000 mg/1?

The NDC (National Drug Code) for Alka-Seltzer Original 1000 mg/1 is 0280-4000, listed by Bayer HealthCare LLC..

Product NDC

0280-4000

Package NDC

0280-4000-01

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

Data from openFDA · Public domain (CC0 1.0)