FDA.reportPublic FDA data

Mag-AL Plus

Manufacturer
Cardinal Health 107, LLC
Effective date
2026-06-10
Label type
HUMAN OTC DRUG LABEL
Version
16
Source
monthly-update
Hydrated at
2026-07-17 21:34:49

Label at a glance#

ProductMag-Al Plus
Active ingredientALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, DIMETHICONE, UNSPECIFIED
Label structure10 sections

Indications and uses

for the relief of: • 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 16 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 four times a day or as directed by a physician children under 12 years consult a physician

Storage and handling

• each 5 mL contains: magnesium 83 mg, sodium 1.34 mg • store at controlled room temperature 20° - 25°C (68° - 77°F) • protect from freezing • White colored, peppermint flavored liquid supplied in the following oral dosage form:   Overbagged with 5 x 30 mL unit dose cup in each bag, NDC 55154-9429-5   WARNING: This Unit Dose package is not child resistant and is Intended for Institutional Use Only. Keep this and a...

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) 200 mg

Antacid

Magnesium hydroxide 200 mg

Antacid

Simethicone 20 mg

Antigas

Uses

INDICATIONS & USAGE SECTION

for the relief of:

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

Warnings

WARNINGS SECTION

Do not take more than 16 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

OTC - ASK DOCTOR/PHARMACIST SECTION

Ask a doctor or pharmacist before use if you are presently taking a prescription drug. Antacids may interact with certain prescription drugs.

OTC - STOP USE SECTION

Stop use and ask a doctor if 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 16 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 four times a day or as directed by a physician

children under 12 years

consult a physician

Other information

STORAGE AND HANDLING SECTION

  • each 5 mL contains: magnesium 83 mg, sodium 1.34 mg
  • store at controlled room temperature 20° - 25°C (68° - 77°F)
  • protect from freezing
  • White colored, peppermint flavored liquid supplied in the following oral dosage form:
  • Overbagged with 5 x 30 mL unit dose cup in each bag, NDC 55154-9429-5
  • WARNING: This Unit Dose package is not child resistant and is Intended for Institutional Use Only. Keep this and all drugs out of the reach of children.

Inactive ingredients

INACTIVE INGREDIENT SECTION

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

Questions or comments?

OTC - QUESTIONS SECTION

Call 1-800-845-8210

SPL UNCLASSIFIED SECTION

MANUFACTURED BY

Pharmaceutical
Associates, Inc.
Greenville, SC 29605

Distributed By:

Cardinal Health

Dublin, OH 43017

L37247540425

F1761300721

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 55154-9429-5

MAG-AL PLUS

5 UNIT DOSE CUPS

1200mg/1200mg/120mg per 30mL bag label
1200mg/1200mg/120mg per 30mL bag label

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130055154942959GTIN-13: 0055154942959
EAN-13: 0055154942959
GTIN-12: 055154942959
UPC-A: 055154942959
GTIN storage (14 digits): 00055154942959		cac7b320-1d1e-47f7-b93d-f16b7726e551-00.jpg

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
6084a4f4-5437-c9a5-caec-5361ee075a59Product name120140508
90c5639a-61b0-88d6-ddcf-21888e94869aProduct name120140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0121-1761-30ML - Milliliter0121-17612c1fbf88-b6c7-428d-83aa-db7980ad038412014-10-03

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
ALUMINUM HYDROXIDEACTIVE INGREDIENT5QB0T2IUN04
DIMETHICONEACTIVE INGREDIENT92RU3N3Y1O4
MAGNESIUM HYDROXIDEACTIVE INGREDIENTNBZ3QY004S4
ALUMINUM HYDROXIDEACTIVE MOIETY5QB0T2IUN04
DIMETHICONEACTIVE MOIETY92RU3N3Y1O4
HYDROXIDE IONACTIVE MOIETY9159UV381P4
BUTYLPARABENINACTIVE INGREDIENT3QPI1U3FV84
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WO4
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V34
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OH4
SACCHARIN SODIUMINACTIVE INGREDIENTSB8ZUX40TY4
SORBITOLINACTIVE INGREDIENT506T60A25R4
WATERINACTIVE INGREDIENT059QF0KO0R4

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
55154-942955154-9429-5
0121-1761

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 10 matching rows.

Name, UNII, Kind table
NameUNIIKind
ALUMINUM HYDROXIDE5QB0T2IUN0ACTIB
MAGNESIUM HYDROXIDENBZ3QY004SACTIB
DIMETHICONE, UNSPECIFIED92RU3N3Y1OACTIB
BUTYLPARABEN3QPI1U3FV8IACT
HYPROMELLOSE, UNSPECIFIED3NXW29V3WOIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
PROPYLPARABENZ8IX2SC1OHIACT
WATER059QF0KO0RIACT
SACCHARIN SODIUMSB8ZUX40TYIACT
SORBITOL506T60A25RIACT

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
152025-05-01full-release2026-06-01 01:00:49

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 · 18 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
HYPROMELLOSESHYPROMELLOSE3NXW29V3WOSUSPENSION / ORAL305 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
PROPYLPARABENPROPYLPARABENZ8IX2SC1OHSUSPENSION / ORAL64 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
SACCHARIN SODIUMSACCHARIN SODIUMSB8ZUX40TYSUSPENSION / ORAL5000 mg/5mlExact identifier — unii+route+dosage form
3 equally ranked IID candidates
SACCHARIN SODIUMSACCHARIN SODIUMSB8ZUX40TYSUSPENSION / ORAL5000 mg/5mlExact identifier — unii+route+dosage form
3 equally ranked IID candidates
BUTYLPARABENBUTYLPARABEN3QPI1U3FV8SUSPENSION / ORAL12 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3SUSPENSION / ORAL27120 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
SACCHARIN SODIUMSACCHARIN SODIUMSB8ZUX40TYSUSPENSION / ORAL5000 mg/5mlExact identifier — unii+route+dosage form
3 equally ranked IID candidates
SORBITOLSORBITOL506T60A25RSUSPENSION / ORAL45000 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
SORBITOLSORBITOL506T60A25RSUSPENSION / ORAL45000 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
PROPYLPARABENPROPYLPARABENZ8IX2SC1OHSUSPENSION / ORAL64 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
SORBITOLSORBITOL506T60A25RSUSPENSION / ORAL45000 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
BUTYLPARABENBUTYLPARABEN3QPI1U3FV8SUSPENSION / ORAL12 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
BUTYLPARABENBUTYLPARABEN3QPI1U3FV8SUSPENSION / ORAL12 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3SUSPENSION / ORAL27120 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
PROPYLPARABENPROPYLPARABENZ8IX2SC1OHSUSPENSION / ORAL64 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3SUSPENSION / ORAL27120 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
HYPROMELLOSESHYPROMELLOSE3NXW29V3WOSUSPENSION / ORAL305 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
HYPROMELLOSESHYPROMELLOSE3NXW29V3WOSUSPENSION / ORAL305 mgExact identifier — unii+route+dosage form
3 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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Mag-AL PlusALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, AND SIMETHICONEPAI Holdings, LLC dba PAI Pharma896ab07a-1b40-43ab-8589-3be86b1c41982026-08-19WarningsExact identifier
ndc (product): 0121-1761
Mag-Al PlusALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, AND SIMETHICONECardinal Health 107, LLC08df7403-9ee3-4a43-a151-c1a6ef7a75492026-06-10WarningsExact identifier
ndc (package): 55154-9429-5
ndc (product): 55154-9429
ndc11 (package): 55154942905
spl id: 4bd8e724-0d46-4734-9b75-62acc758ff10
spl set id: 08df7403-9ee3-4a43-a151-c1a6ef7a7549

Reported adverse events (FAERS/openFDA)#

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