Aluminum hydroxide

Overview

Aluminum hydroxide is an inorganic salt used as an antacid. It is a basic compound that acts by neutralizing hydrochloric acid in gastric secretions. Subsequent increases in pH may inhibit the action of pepsin. An increase in bicarbonate ions and prostaglandins may also confer cytoprotective effects.

Indication

For relief of heartburn and acid indigestion.

Associated Conditions

Abdominal Pain
Acid Regurgitation
Anginal Pain caused by Gas
Bloating
Colic
Duodenal Ulcer
Dyspepsia
Flatulence
Gastric Ulcer
Gastroesophageal Reflux
Heartburn
Hyperphosphataemia
Pain, Inflammatory
Reflux Acid
Skin Irritation
Upset stomach
Stomach pains caused by Gastric Acid

Clinical Trials

Title	Posted	Study ID	Phase	Status	Sponsor
Phase I STEBVax in Healthy Adults	2009/09/11	NCT00974935	Phase 1	Completed	National Institute of Allergy and Infectious Diseases (NIAID)
SARS Coronavirus Vaccine (SARS-CoV)	2007/09/21	NCT00533741	Phase 1	Withdrawn	National Institute of Allergy and Infectious Diseases (NIAID)
Effects of Recombinant Human Glutamic Acid Decarboxylase on the Progression of Type 1 Diabetes in New Onset Subjects	2007/09/14	NCT00529399	Phase 2	Completed	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
H5 Vaccine Alone or With Adjuvant in Healthy Adults	2006/02/27	NCT00296634	Phase 1	Completed	National Institute of Allergy and Infectious Diseases (NIAID)
Parathyroid Hormone Levels in Relation to the Phosphorus Content of Meals	2001/07/05	NCT00018135	Not Applicable	Completed	National Center for Research Resources (NCRR)

FDA Drug Approvals

Approved Product	Manufacturer	NDC Code	Route	Strength	Effective Date
Gaviscon Extra Strength	Haleon US Holdings LLC	0135-0098	ORAL	160 mg in 1 1	5/15/2025
Gaviscon Extra Strength	Haleon US Holdings LLC	0135-0430	ORAL	160 mg in 1 1	5/15/2025
Mag-Al Plus	Cardinal Health 107, LLC	55154-9429	ORAL	200 mg in 5 mL	5/1/2025
KO-LANTA	Geri-Care Pharmaceuticals, Corp	57896-004	ORAL	200 mg in 5 mL	3/31/2025
GERI-LANTA ANTACID ANTIGAS	ATLANTIC BIOLOGICALS CORP.	17856-0630	ORAL	200 mg in 5 mL	5/12/2025
GAVISCON	Haleon US Holdings LLC	0135-0095	ORAL	254 mg in 5 mL	5/27/2025
MINTOX MAXIMUM STRENGTH	ATLANTIC BIOLOGICALS CORP.	17856-5725	ORAL	400 mg in 5 mL	5/23/2025
GAVISCON	Haleon US Holdings LLC	0135-0094	ORAL	95 mg in 15 mL	5/27/2025
GAVISCON	Haleon US Holdings LLC	0135-0574	ORAL	254 mg in 5 mL	5/27/2025
Aluminum Hydroxide	ATLANTIC BIOLOGICALS CORP.	17856-0091	ORAL	320 mg in 5 mL	5/12/2025

EMA Drug Approvals

Approved Product	Authorization Holder	Status	Issued Date
No EMA approvals found for this drug.

HSA Drug Approvals

Approved Product	Manufacturer	Approval Number	Dosage Form	Strength	Approval Date
ACTAL TABLET 216 mg	PHARMANIAGA MANUFACTURING BERHAD, PT. MENARINI INDRIA LABORATORIES	SIN03572P	TABLET	216 mg	6/30/1989
GUARDIAN ANTACID TABLET	SUNWARD PHARMACEUTICAL PRIVATE LIMITED	SIN08171P	TABLET	250 mg	5/12/1995
HYDROSIL TABLET	XEPA-SOUL PATTINSON (MALAYSIA) SDN BHD	SIN03484P	TABLET	200 mg	6/24/1989
MACGEL TABLET	Y S P INDUSTRIES (M) SDN BHD	SIN08119P	TABLET	200 mg	4/11/1995
ALUMINIUM HYDROXIDE TABLET 600 mg	SUNWARD PHARMACEUTICAL PRIVATE LIMITED	SIN02914P	TABLET, FILM COATED	600 mg	5/22/1989
WELUSIL TABLET	BEACONS PHARMACEUTICALS PTE. LTD.	SIN05336P	TABLET	250 mg	1/12/1991
ALUMAG TABLETS	BEACONS PHARMACEUTICALS PTE LTD	SIN03159P	TABLET	250 mg	6/8/1989
ALU-TAB TABLET 600 mg	Adcock Ingram Limited	SIN02930P	TABLET, FILM COATED	600 mg	5/22/1989
INON GRANULES	SATO PHARMACEUTICAL CO LTD	SIN03440P	GRANULE	525 mg/1.8 g	6/8/1989
WEISEN-U TABLET	Jean-Marie Pharmacal Co Ltd	SIN09280P	TABLET, FILM COATED	192 mg	4/2/1997

NMPA Drug Approvals

Approved Product	Company	Approval Number	Drug Type	Dosage Form	Approval Date
No NMPA approvals found for this drug.

PPB Drug Approvals

Approved Product	Registration No.	Company	Licence No.	Strength	Registration Date
VIDA-MECO SUSP ORAL	N/A	MARCHING PHARMACEUTICAL LIMITED	N/A	N/A	2/6/1987
SIMWELL CHEWABLE TABLETS	N/A	HITPHARM PHARMACEUTICAL COMPANY LIMITED	N/A	N/A	11/6/2017
GASEDIN-U EXTRA STOMACH CHEWABLE TAB	N/A	ADVANCE PHARMACEUTICAL COMPANY LIMITED	N/A	N/A	12/28/2006
SIMEGEL SUSPENSION (WHITE)	N/A	MEDIPHARMA	N/A	N/A	7/16/1999
SILOX-50 SUSP ORAL	N/A	JEAN-MARIE PHARMACAL COMPANY LIMITED	N/A	N/A	3/7/1986
MAALOX PLUS TAB	N/A	SUNSTONE CHINA LIMITED	N/A	N/A	10/12/1978
TAITIAN STOMACH TAB	N/A	Man Hing Medicine Traders	N/A	N/A	5/17/1999
FEDRA-GEL-S CHEWABLE TAB	N/A	MARCHING PHARMACEUTICAL LIMITED	N/A	N/A	7/4/1984
STROCAIN TAB	N/A	EISAI (HONG KONG) COMPANY LIMITED	N/A	N/A	9/6/1988
WEICHI TAB	N/A	WILCOME PHARMACEUTICAL COMPANY LIMITED	N/A	N/A	5/3/1995

TGA Drug Approvals

Approved Product	ARTG ID	Sponsor	Registration Type	Status	Registration Date
MYLANTA 2go ANTACID ORIGINAL chewable tablet (reformulation) blister pack	118511	Johnson & Johnson Pacific Pty Ltd	Medicine	A	5/11/2005
GASTROGEL ANTACID oral liquid bottle	13452	Arrotex Pharmaceuticals Pty Ltd	Medicine	A	8/30/1991
MYLANTA DOUBLE STRENGTH oral liquid bottle (reformulation 2)	126090	Johnson & Johnson Pacific Pty Ltd	Medicine	A	3/10/2006
MYLANTA ANTACID DOUBLE STRENGTH oral liquid bottle	294406	Johnson & Johnson Pacific Pty Ltd	Medicine	A	9/27/2017
MYLANTA P ANTACID oral liquid bottle (reformulation)	121994	Johnson & Johnson Pacific Pty Ltd	Medicine	A	9/19/2005
MYLANTA ORIGINAL oral liquid bottle (reformulation 2)	122007	Johnson & Johnson Pacific Pty Ltd	Medicine	A	9/19/2005
MYLANTA ANTACID ORIGINAL oral liquid bottle	294405	Johnson & Johnson Pacific Pty Ltd	Medicine	A	9/27/2017
MYLANTA P ANTACID chewable tablet blister pack	118509	Johnson & Johnson Pacific Pty Ltd	Medicine	A	5/11/2005
MYLANTA 2go ANTACID DOUBLE STRENGTH chewable tablet (reformulation) blister pack	118508	Johnson & Johnson Pacific Pty Ltd	Medicine	A	5/11/2005
ALU-TAB aluminium hydroxide dried 600mg tablet - film coated bottle	58664	iNova Pharmaceuticals (Australia) Pty Ltd	Medicine	A	1/29/1997

Health Canada Drug Approvals

Approved Product	Company	DIN	Dosage Form	Strength	Market Date
STOMAAX	theralab inc.	00547239	Suspension - Oral	200 MG / 5 ML	12/31/1982
GELUSIL EXTRA STRENGTH LIQ	warner-lambert canada inc.	01945858	Liquid - Oral	650 MG / 5 ML	12/31/1992
ANTACID LIQUID SUSP	shoppers drug mart inc.	00417920	Suspension - Oral	200 MG / 5 ML	12/31/1977
ANTACID MAGNESIA AND ALUMINA	stanley pharmaceuticals, a division of vita health products inc.	00854611	Suspension - Oral	228 MG / 5 ML	12/31/1993
RAFTON LIQUID - FRUIT FLAVOUR	Ferring Inc	01992473	Liquid - Oral	100 MG / 5 ML	12/31/1995
MYLANTA TABLETS DOUBLE STRENGTH	mcneil consumer healthcare division of johnson & johnson inc	02019787	Tablet - Oral	400 MG	12/31/1993
STOMAAX PLUS	laboratoire atlas inc	00623709	Suspension - Oral	200 MG / 5 ML	12/31/1989
MAALOX PLUS SUSPENSION EXTRA STRENGTH	novartis consumer health canada inc.	02162342	Suspension - Oral	100 MG / ML	7/30/1996
MAALOX PLUS EXTRA STRENGTH (CHERRY)	rhone-poulenc rorer consumer inc.	01958496	Tablet - Oral	350 MG / TAB	12/31/1992
GAVISCON TABLETS	glaxosmithkline consumer healthcare ulc	02159783	Tablet - Oral	80 MG	12/31/1996

CIMA AEMPS Drug Approvals

Approved Product	Company	Registration Number	Pharmaceutical Form	Prescription Type	Status
No CIMA AEMPS (Spain) approvals found for this drug.

Philippines FDA Drug Approvals

Approved Product	Company	License Number	Dosage Form	Strength	Approval Date
No Philippines FDA approvals found for this drug.

Saudi SFDA Drug Approvals

Approved Product	Company	License Number	Dosage Form	Strength	Approval Date
No Saudi SFDA approvals found for this drug.

Malaysia NPRA Drug Approvals

Approved Product	Company	Registration Number	Dosage Form	Strength	Approval Date
No Malaysia NPRA approvals found for this drug.

UK EMC Drug Information

Medicine Name	MA Holder	MA Number	Pharmaceutical Form	Active Ingredient	Authorization Date
No UK EMC drug information found for this drug.

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