FDA.reportPublic FDA data

Mag-AL Plus

Manufacturer
PAI Holdings, LLC dba PAI Pharma | PAI Holdings, LLC dba Pharmaceutical Associates, Inc. and dba PAI Pharma
Effective date
2024-11-12
Label type
HUMAN OTC DRUG LABEL
Version
8
Source
full-release
Hydrated at
2026-06-01 00:36:54

Label at a glance#

ProductMag-AL Plus XS
Active ingredientALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, DIMETHICONE
Label structure9 sections

Indications and uses

acid indigestion heartburn sour stomach upset stomach due to these symptoms pressure and bloating commonly referred to as gas

Dosage and administration

shake well before using do not take more than 8 teaspoonfuls in 24 hours or use the maximum dosage for more than 2 weeks adults and children 12 years and older take 2 to 4 teaspoonfuls two times a day or as directed by a physician children under 12 years consult a physician

Storage and handling

each 5 mL contains: magnesium 167 mg, sodium 2.24 mg store at controlled room temperature 20° - 25°C (68° - 77°F) [see USP Controlled Room Temperature]. protect from freezing White colored, cherry flavored liquid supplied in the following oral dosage form: NDC 0121-1762-30: 30 mL unit dose cup. Case contains 100 unit dose cups of 30 mL packaged in 10 trays of 10 unit dose cups each. *Maalox is a registered tradema...

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

OTC - PURPOSE SECTION

Active ingredients (in each 5 mL = 1 teaspoonful)Purpose
Aluminum hydroxide (equiv. to dried gel, USP) 400 mgAntacid
Magnesium hydroxide 400 mgAntacid
Simethicone 40 mgAntigas

Uses for the relief of:

INDICATIONS & USAGE SECTION

  • acid indigestion
  • heartburn
  • sour stomach
  • upset stomach due to these symptoms
  • pressure and bloating commonly referred to as gas

Warnings

WARNINGS SECTION

OTC - DO NOT USE SECTION

Do not take more than 8 teaspoonfuls in a 24-hour period or use the maximum dosage for more than 2 weeks except under the advice and supervision of a physician.

Ask a doctor before use if you have

OTC - ASK DOCTOR SECTION

  • kidney disease
  • a magnesium-restricted diet

Ask a doctor or pharmacist before use if you are

OTC - ASK DOCTOR/PHARMACIST SECTION

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

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • symptoms last more than 2 weeks.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

Directions

DOSAGE & ADMINISTRATION SECTION

  • shake well before using
  • do not take more than 8 teaspoonfuls in 24 hours or use the maximum dosage for more than 2 weeks
adults and children 12 years and oldertake 2 to 4 teaspoonfuls two times a day or as directed by a physician
children under 12 yearsconsult a physician

Other information

STORAGE AND HANDLING SECTION

  • each 5 mL contains: magnesium 167 mg, sodium 2.24 mg
  • store at controlled room temperature 20° - 25°C (68° - 77°F) [see USP Controlled Room Temperature].
  • protect from freezing
  • White colored, cherry flavored liquid supplied in the following oral dosage form:

NDC 0121-1762-30: 30 mL unit dose cup. Case contains 100 unit dose cups of 30 mL packaged in 10 trays of 10 unit dose cups each.

*Maalox is a registered trademark of Novartis Consumer Health, Inc.

Inactive ingredients

INACTIVE INGREDIENT SECTION

Butylparaben, hydroxypropyl methylcellulose, flavoring, propylene glycol, propylparaben, purified water, sodium saccharin, and sorbitol solution.

SPL UNCLASSIFIED SECTION

MANUFACTURED BY

Pharmaceutical
Associates, Inc.
Greenville, SC 29605
www.paipharma.com

PRINCIPAL DISPLAY PANEL - 30 mL Cup Tray Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Delivers 30 mL

NDC 0121-1762-30

MAG-AL PLUS XS

Each 30 mL contains:

Magnesium Hydroxide 2400 mg
Aluminum Hydroxide 2400 mg
Simethicone 240 mg

SHAKE WELL

Package Not Child-Resistant

Pharmaceutical Associates, Inc.
Greenville, SC 29605

See Insert

PRINCIPAL DISPLAY PANEL - 30 mL Cup Tray Label
PRINCIPAL DISPLAY PANEL - 30 mL Cup Tray Label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
237870aluminum hydroxide 400 MG / magnesium hydroxide 400 MG / simethicone 40 MG in 5 mL Oral SuspensionPSN8
237870aluminum hydroxide 80 MG/ML / magnesium hydroxide 80 MG/ML / simethicone 8 MG/ML Oral SuspensionSCD8
237870aluminum hydroxide 2400 MG / magnesium hydroxide 2400 MG / dimethicone 240 MG per 30 ML Oral SuspensionSY8
237870aluminum hydroxide 400 MG / magnesium hydroxide 400 MG / simethicone 40 MG per 5 ML Oral SuspensionSY8
237870aluminum hydroxide 800 MG / magnesium hydroxide 800 MG / dimethicone 80 MG per 10 ML Oral SuspensionSY8

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
DIMETHICONE Pharmacologic Class Indexing3Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6e3c022f-0786-43f1-8857-edff89d5153fProduct name120260309
95250459-30e4-45c1-b08a-993044f49109Product name220250805
efd58652-cb8f-4018-91ca-4b0eb2ff729fProduct name720240226
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
9badc7be-250a-44ab-aa36-926af3f02679Product name120210527
2641ccb3-721d-4fbf-9f2f-ca2f18157a62Product name320210309
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125
26acd337-b838-40ac-bcbc-05c3b81c8712Product name120170323
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
e7e58cd3-cacb-49df-8d34-1ee335614abbProduct name120150609
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0121-1762-30Mag-AL PlusXS10 in 1 TRAYSUSPENSION108
0121-1762-30Mag-AL PlusXS10 in 1 CASESUSPENSION108

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0121-1762MAG-AL PLUS XS (ALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, AND DIMETHICONE) SUSPENSION [PAI HOLDINGS, LLC DBA PAI PHARMA]8Current NDC, Legacy NDC, 2 package rows20241114_db0c47ab-5296-4195-9fa6-2e338b665094.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0121-1762-30ML - Milliliter0121-176215a221d5-f2b9-4738-a87a-18544a2c7c7112014-10-03

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
Aluminum HydroxideACTIVE INGREDIENT5QB0T2IUN01
DimethiconeACTIVE INGREDIENT92RU3N3Y1O1
Magnesium HydroxideACTIVE INGREDIENTNBZ3QY004S1
Aluminum HydroxideACTIVE MOIETY5QB0T2IUN01
DimethiconeACTIVE MOIETY92RU3N3Y1O1
Hydroxide IonACTIVE MOIETY9159UV381P1
ButylparabenINACTIVE INGREDIENT3QPI1U3FV81
Cyclomethicone 4INACTIVE INGREDIENTCZ227117JE1
Hypromellose 2910 (4000 mpa.s)INACTIVE INGREDIENTRN3152OP351
Peppermint OilINACTIVE INGREDIENTAV092KU4JH1
Propylene GlycolINACTIVE INGREDIENT6DC9Q167V31
PropylparabenINACTIVE INGREDIENTZ8IX2SC1OH1
Saccharin SodiumINACTIVE INGREDIENTSB8ZUX40TY1
SorbitolINACTIVE INGREDIENT506T60A25R1
WaterINACTIVE INGREDIENT059QF0KO0R1

Products#

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

DailyMed product names page 1 of 1 · 16 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
0121-17620121-1762-30

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 12 matching rows.

Name, UNII, Kind table
NameUNIIKind
ALUMINUM HYDROXIDE5QB0T2IUN0ACTIB
MAGNESIUM HYDROXIDENBZ3QY004SACTIB
DIMETHICONE92RU3N3Y1OACTIB
BUTYLPARABEN3QPI1U3FV8IACT
PROPYLPARABENZ8IX2SC1OHIACT
HYPROMELLOSE 2910 (4000 MPA.S)RN3152OP35IACT
PROPYLENE GLYCOL6DC9Q167V3IACT
SORBITOL506T60A25RIACT
SACCHARIN SODIUMSB8ZUX40TYIACT
PEPPERMINT OILAV092KU4JHIACT
CYCLOMETHICONE 4CZ227117JEIACT
WATER059QF0KO0RIACT

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 · 14 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
PropylparabenPROPYLPARABENZ8IX2SC1OHSUSPENSION / ORAL64 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
Saccharin SodiumSACCHARIN SODIUMSB8ZUX40TYSUSPENSION / ORAL5000 mg/5mlExact identifier — unii+route+dosage form
2 equally ranked IID candidates
ButylparabenBUTYLPARABEN3QPI1U3FV8SUSPENSION / ORAL12 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
PropylparabenPROPYLPARABENZ8IX2SC1OHSUSPENSION / ORAL64 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
Saccharin SodiumSACCHARIN SODIUMSB8ZUX40TYSUSPENSION / ORAL5000 mg/5mlExact identifier — unii+route+dosage form
2 equally ranked IID candidates
SorbitolSORBITOL506T60A25RSUSPENSION / ORAL45000 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
ButylparabenBUTYLPARABEN3QPI1U3FV8SUSPENSION / ORAL12 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
Propylene GlycolPROPYLENE GLYCOL6DC9Q167V3SUSPENSION / ORAL27120 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
SorbitolSORBITOL506T60A25RSUSPENSION / ORAL45000 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
Hypromellose 2910 (4000 mpa.s)HYPROMELLOSE 2910 (4000 MPA.S)RN3152OP35SUSPENSION / ORAL360 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
Peppermint OilPEPPERMINT OILAV092KU4JHSUSPENSION / ORAL100 mg/1mlExact identifier — unii+route+dosage form
2 equally ranked IID candidates
Hypromellose 2910 (4000 mpa.s)HYPROMELLOSE 2910 (4000 MPA.S)RN3152OP35SUSPENSION / ORAL360 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
Peppermint OilPEPPERMINT OILAV092KU4JHSUSPENSION / ORAL100 mg/1mlExact identifier — unii+route+dosage form
2 equally ranked IID candidates
Propylene GlycolPROPYLENE GLYCOL6DC9Q167V3SUSPENSION / ORAL27120 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
Mag-AL Plus XSALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, AND DIMETHICONEPAI Holdings, LLC dba PAI Pharmadb0c47ab-5296-4195-9fa6-2e338b6650942024-11-12WarningsExact identifier
ndc (package): 0121-1762-30
ndc (product): 0121-1762
ndc11 (package): 00121176230
spl id: b950b648-4292-4b99-ad30-52f554434f27
spl set id: db0c47ab-5296-4195-9fa6-2e338b665094

Reported adverse events (FAERS/openFDA)#

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