FDA.reportPublic FDA data

Maximum Strength Antacid Mint Flavor

Manufacturer
Guardian Drug Company
Effective date
2026-07-14
Label type
Human OTC Drug Label
Version
2
Source
daily-update
Hydrated at
2026-07-18 05:10:13

Label at a glance#

ProductMaximum Strength Antacid Mint
Active ingredientDIMETHICONE
Label structure9 sections

Dosage and administration

chew 1 to 2 tablets thoroughly as needed after meals and at bedtime do not exceed 4 tablets in a 24 hour period except under the advice and supervision of a physician

Storage and handling

do  not use if inner seal is broken store at room temperature avoid high humidity and excessive heat, above 40 o C (104 o F)

Label contents#

Full prescribing information#

ACTIVE INGREDIENT(in each tablet)

OTC - ACTIVE INGREDIENT SECTION

Simethicone 125 mg

PURPOSE

OTC - PURPOSE SECTION

Anti-gas

USE(S)

INDICATIONS & USAGE SECTION

relieves:


  • pressure
  • bloating
  • symptoms referred to as gas

WARNINGS

WARNINGS SECTION

.

KEEP OUT OF REACH OF CHILDREN

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of the reach of children. In case of overdose, get medical help or contact a Poison Control Center immediately. 

DIRECTIONS

DOSAGE & ADMINISTRATION SECTION

  • chew 1 to 2 tablets thoroughly as needed after meals and at bedtime
  • do not exceed 4 tablets in a 24 hour period except under the advice and supervision of a physician

OTHER INFORMATION

STORAGE AND HANDLING SECTION

  • do  not use if inner seal is broken
  • store at room temperature
  • avoid high humidity and excessive heat, above 40oC (104oF)

INACTIVE INGREDIENTS

INACTIVE INGREDIENT SECTION

compressible sugar, dextrose, flavor, magnesium stearate, maltodextrin, microcrystalline cellulose, sorbitol.

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Guardian

Maximum Strength
Antacid
Mint Flavor
Simethicone 125 mg/Anti-gas
Relieves Symptoms of Gas

60 Chewable Tablets (125 mg Ea.)

131-60-gdc.jpg131-60-gdc.jpg

Products#

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

DailyMed product names page 1 of 1 · 9 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
53041-10053041-100-23

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 7 matching rows.

Name, UNII, Kind table
NameUNIIKind
DIMETHICONE92RU3N3Y1OACTIB
SUCROSEC151H8M554IACT
MALTODEXTRIN7CVR7L4A2DIACT
DEXTROSE, UNSPECIFIED FORMIY9XDZ35W2IACT
MAGNESIUM STEARATE70097M6I30IACT
MICROCRYSTALLINE CELLULOSEOP1R32D61UIACT
SORBITOL506T60A25RIACT

Source Document#

Source XML

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
Maximum Strength Antacid MintSIMETHICONEGuardian Drug Company48ec3132-17cf-1de9-e063-6294a90aa4072026-07-14WarningsExact identifier
ndc (package): 53041-100-23
ndc (product): 53041-100
ndc11 (package): 53041010023
spl id: 7686d6a2-1def-4f14-abe2-fff152289471
spl set id: 48ec3132-17cf-1de9-e063-6294a90aa407

Reported adverse events (FAERS/openFDA)#

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