Drugplain

Gaviscon Extra Strength 160 mg/1

aluminum hydroxide and magnesium carbonate · TABLET, CHEWABLE · Haleon US Holdings LLC

1 Recall on Record
Plain English

Gaviscon Extra Strength is an over-the-counter antacid tablet that contains aluminum hydroxide and magnesium carbonate to relieve heartburn and acid indigestion. You chew the tablet by mouth when you experience these symptoms.

Key Facts

Brand Name
Gaviscon Extra Strength
Generic Name
aluminum hydroxide and magnesium carbonate
NDC Code (Product)
0135-0098
Manufacturer
Haleon US Holdings LLC
Strength
160 mg/1
Dosage Form
TABLET, CHEWABLE
Route
ORAL
Marketing Status
Application #
M001
Marketing Start
06/13/2011

Recall History

1 Recall on Record
Class II05/28/2020

Glaxosmithkline Consumer Healthcare Holdings

Labeling: Label lacks warning - Magnesium safety warning is not present on the Gaviscon bottle label.

TerminatedVoluntary: Firm initiated

Side Effects Reported to FDA

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

chronic kidney disease457 reports
diarrhoea403 reports
acute kidney injury397 reports
nausea392 reports
vomiting389 reports
dyspnoea371 reports
fatigue360 reports
headache347 reports
malaise289 reports
pain288 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

Uses relieves • acid indigestion • heartburn • sour stomach • upset stomach associated with these symptoms

Dosage & Administration

Directions • chew 2-4 tablets four times a day or as directed by a doctor • take after meals and at bedtime or as needed • for best results follow by a half glass of water or other liquid • DO NOT SWALLOW WHOLE

Warnings

Warnings Ask a doctor or pharmacist before use if you are • taking a prescription drug. Antacids may interact with certain prescription drugs. • if you are on a sodium-restricted diet When using this product • do not take more than 16 tablets in 24 hours • do not use the maximum dosage for more than 2 weeks Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

Frequently Asked Questions

What is Gaviscon Extra Strength used for?

Gaviscon Extra Strength is an over-the-counter antacid tablet that contains aluminum hydroxide and magnesium carbonate to relieve heartburn and acid indigestion. You chew the tablet by mouth when you experience these symptoms.

Is Gaviscon Extra Strength a controlled substance?

Gaviscon Extra Strength is not classified as a controlled substance by the DEA.

What is the generic name for Gaviscon Extra Strength?

The generic name for Gaviscon Extra Strength is aluminum hydroxide and magnesium carbonate. There are 10 other brand versions of aluminum hydroxide and magnesium carbonate.

What is the NDC code for Gaviscon Extra Strength 160 mg/1?

The NDC (National Drug Code) for Gaviscon Extra Strength 160 mg/1 is 0135-0098, listed by Haleon US Holdings LLC.