FDA.reportPublic FDA data

Aluminum hydroxide and Magnesium carbonate

Manufacturer
Simpex Pharma Pvt. Ltd
Effective date
2023-11-29
Label type
HUMAN OTC DRUG LABEL
Version
7
Source
full-release
Hydrated at
2026-06-01 00:03:04

Label at a glance#

ProductAluminum hydroxide and Magnesium carbonate
Active ingredientALUMINUM HYDROXIDE, MAGNESIUM CARBONATE
Label structure7 sections

Indications and uses

Relieves acid indigestion leading to stomach upset heart burn

Dosage and administration

chew 2 to 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

Label contents#

Full prescribing information#

Active ingredient (in each tablet)

OTC - ACTIVE INGREDIENT SECTION

Aluminum hydroxide, 160 mg

Magnesium carbonate, 105 mg

Purpose

OTC - PURPOSE SECTION

Antacid

Uses

INDICATIONS & USAGE SECTION

Relieves acid indigestion leading to

  • stomach upset
  • heart burn

Warnings

WARNINGS SECTION

Ask a doctor before use if you have

OTC - ASK DOCTOR SECTION

  • kidney disease
  • a magnesium or sodium-restricted diet

Ask a doctor or pharmacist before use if you are

OTC - ASK DOCTOR/PHARMACIST SECTION

  • now taking a prescription drug. Antacids may interact with certain prescription drugs.

When using this product

OTC - WHEN USING SECTION

do not take more than 16 tablets in a 24-hour period or use the maximum dosage for more than 2 weeks

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Directions

DOSAGE & ADMINISTRATION SECTION

  • chew 2 to 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

Other information

SPL UNCLASSIFIED SECTION

  • each tablet contains: magnesium 50 mg and sodium 32 mg
  • store at 20°-25°C

Inactive ingredients

INACTIVE INGREDIENT SECTION

alginic acid, calcium stearate, color red iron oxide, flavor (mint), maize starch, magnesium oxide, mannitol, sodium bicarbonate, sucrose

Package Labeling:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LabelLabel

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
308072aluminum hydroxide 160 MG / magnesium carbonate 105 MG Chewable TabletPSN7
308072aluminum hydroxide 160 MG / magnesium carbonate 105 MG Chewable TabletSCD7

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
76457-001-00Aluminum hydroxide and Magnesium carbonate1 in 1 CARTONTABLET, CHEWABLE17
76457-001-00Aluminum hydroxide and Magnesium carbonate100 in 1 BOTTLETABLET, CHEWABLE1007

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
76457-001ALUMINUM HYDROXIDE AND MAGNESIUM CARBONATE (ALUMINUM HYDROXIDE, MAGNESIUM CARBONATE) TABLET, CHEWABLE [SIMPEX PHARMA PVT. LTD]7Current NDC, Legacy NDC, 2 package rows20231201_e799a555-bfd0-4298-a5dc-aeb671815d40.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
ALUMINUM HYDROXIDEACTIVE INGREDIENT5QB0T2IUN03
MAGNESIUM CARBONATEACTIVE INGREDIENT0E53J927NA3
ALUMINUM HYDROXIDEACTIVE MOIETY5QB0T2IUN03
CARBONATE IONACTIVE MOIETY7UJQ5OPE7D3
ALGINIC ACIDINACTIVE INGREDIENT8C3Z4148WZ3
CALCIUM STEARATEINACTIVE INGREDIENT776XM7047L3
MANNITOLINACTIVE INGREDIENT3OWL53L36A3
SODIUM BICARBONATEINACTIVE INGREDIENT8MDF5V39QO3
SUCROSEINACTIVE INGREDIENTC151H8M5543
WATERINACTIVE INGREDIENT059QF0KO0R3

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 14 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
76457-00176457-001-00

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 11 matching rows.

Name, UNII, Kind table
NameUNIIKind
ALGINIC ACID8C3Z4148WZIACT
CALCIUM STEARATE776XM7047LIACT
FERRIC OXIDE RED1K09F3G675IACT
METHYL SALICYLATELAV5U5022YIACT
STARCH, CORNO8232NY3SJIACT
MAGNESIUM OXIDE3A3U0GI71GIACT
MANNITOL3OWL53L36AIACT
SODIUM BICARBONATE8MDF5V39QOIACT
SUCROSEC151H8M554IACT
ALUMINUM HYDROXIDE5QB0T2IUN0ACTIB
MAGNESIUM CARBONATE0E53J927NAACTIB

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 1 · 10 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
MANNITOLMANNITOL3OWL53L36ATABLET, CHEWABLE / ORAL3726 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
SODIUM BICARBONATESODIUM BICARBONATE8MDF5V39QOTABLET, CHEWABLE / ORAL140 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
ALGINIC ACIDALGINIC ACID8C3Z4148WZTABLET, CHEWABLE / ORAL400 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
MANNITOLMANNITOL3OWL53L36ATABLET, CHEWABLE / ORAL3726 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
SUCROSESUCROSEC151H8M554TABLET, CHEWABLE / ORAL7258 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
SUCROSESUCROSEC151H8M554TABLET, CHEWABLE / ORAL7258 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
SODIUM BICARBONATESODIUM BICARBONATE8MDF5V39QOTABLET, CHEWABLE / ORAL140 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
ALGINIC ACIDALGINIC ACID8C3Z4148WZTABLET, CHEWABLE / ORAL400 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
CALCIUM STEARATECALCIUM STEARATE776XM7047LTABLET, CHEWABLE / ORAL240 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
CALCIUM STEARATECALCIUM STEARATE776XM7047LTABLET, CHEWABLE / ORAL240 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Aluminum hydroxide and Magnesium carbonateALUMINUM HYDROXIDE, MAGNESIUM CARBONATESimpex Pharma Pvt. Ltde799a555-bfd0-4298-a5dc-aeb671815d402023-11-29WarningsExact identifier
ndc (package): 76457-001-00
ndc (product): 76457-001
ndc11 (package): 76457000100
spl id: 0b5850de-34f4-b95e-e063-6294a90affe1
spl set id: e799a555-bfd0-4298-a5dc-aeb671815d40

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.