Drugplain

Alka-Seltzer Gold 1000 mg/1

Alka-Seltzer Gold · TABLET, EFFERVESCENT · Bayer HealthCare LLC.

1 Recall on Record
Plain English

Alka-Seltzer Gold is an over-the-counter antacid tablet that you dissolve in water to help relieve heartburn, acid indigestion, and upset stomach. Each tablet contains 1000 mg of active ingredients designed to neutralize stomach acid and provide quick relief.

Key Facts

Brand Name
Alka-Seltzer Gold
Generic Name
Alka-Seltzer Gold
NDC Code (Product)
0280-4100
Manufacturer
Bayer HealthCare LLC.
Strength
1000 mg/1
Dosage Form
TABLET, EFFERVESCENT
Route
ORAL
Marketing Status
HUMAN OTC DRUG
Application #
M001
Drug Class
Acidifying Activity [MoA]; Anti-coagulant [EPC]
Marketing Start
11/19/2014

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

drug dependence14 reports
product use in unapproved indication9 reports
drug effective for unapproved indication7 reports
death5 reports
headache4 reports
incorrect drug administration duration4 reports
product use issue4 reports
therapeutic response unexpected4 reports
drug hypersensitivity3 reports
incorrect dose administered3 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

Uses for the relief of ● heartburn ● acid indigestion ● sour stomach

Dosage & Administration

Directions ● fully dissolve tablets in 4 ounces of water before taking adults and children 12 years and over 2 tablets every 4 hours as needed, or asdirected by a doctor do not exceed8 tablets in 24 hours adults 60 years and over 2 tablets every 4 hours as needed, or as directed by a doctor do not exceed 6 tablets in 24 hours children under 12 years 1 tablet every 4 hours as needed, or as directed by a doctor do not exceed 4 tablets in 24 hours

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 Gold used for?

Alka-Seltzer Gold is an over-the-counter antacid tablet that you dissolve in water to help relieve heartburn, acid indigestion, and upset stomach. Each tablet contains 1000 mg of active ingredients designed to neutralize stomach acid and provide quick relief.

Is Alka-Seltzer Gold a controlled substance?

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

What is the generic name for Alka-Seltzer Gold?

The generic name for Alka-Seltzer Gold is Alka-Seltzer Gold. There are no other listed brand versions of Alka-Seltzer Gold.

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

The NDC (National Drug Code) for Alka-Seltzer Gold 1000 mg/1 is 0280-4100, listed by Bayer HealthCare LLC..

Product NDC

0280-4100

Package NDC

0280-4100-63

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

Data from openFDA · Public domain (CC0 1.0)