FDA.reportPublic FDA data

Mylanta Gas Minis Chewable Tablets

Manufacturer
Infirst Healthcare Inc.
Effective date
2023-12-04
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
full-release
Hydrated at
2026-06-01 00:05:00

Label at a glance#

ProductMylanta Gas Minis Assorted Fruit Flavor
Active ingredientDIMETHICONE
Label structure9 sections

Indications and uses

Relieves pressure and bloating commonly referred to as gas

Dosage and administration

Adults and children 12 years and older : thoroughly chew 3-6 mini-tablets as needed. • do not exceed 12 mini-tablets in 24 hours except under the advice and supervision of a physician.

Storage and handling

each dose contains: calcium 75 mg • protect from heat and moisture • store at 20-25° C (68-77° F)

Label contents#

Full prescribing information#

Active ingredient (in each 3 tablet dose)

OTC - ACTIVE INGREDIENT SECTION

Simethicone 125 mg

Purpose

OTC - PURPOSE SECTION

Anti-gas

Uses

INDICATIONS & USAGE SECTION

Relieves pressure and bloating commonly referred to as gas

Warnings

WARNINGS SECTION

Keep out of the reach of children.

Keep out of reach of children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Directions

DOSAGE & ADMINISTRATION SECTION

  • Adults and children 12 years and older: thoroughly chew 3-6 mini-tablets as needed.

    • do not exceed 12 mini-tablets in 24 hours except under the advice and supervision of a physician.

Other information

STORAGE AND HANDLING SECTION

  • each dose contains: calcium 75 mg
    • protect from heat and moisture
    • store at 20-25° C (68-77° F)

Inactive ingredients

INACTIVE INGREDIENT SECTION

adipic acid , carboxymethylcellulose sodium ,D&C red 27 lake, FD&C blue 1 lake, FD &C yellow 6 lake, flavors, hydroxypropyl cellulose, isomalt, magnesium stearate, maltodextrin, silica, sucralose, sucrose, tricalcium phosphate,

Questions or comments?

OTC - QUESTIONS SECTION

call 1-844-695-6624toll free (English & Spanish)

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

FREE 20% MORE

CONVENIENT POCKET PACK

Mylanta ®

GAS Minis

  • Fast relief of the bloating , pressure, and discomfort of gas
  • Extra Strength, with the #1 selling medicine for gas relief
  • Great tasting ,chewable mini-tablets in an on-the-go pack
  • Also available in great tasting Arctic Mint & Cherry

TAMPER EVIDENT: DO NOT USE MYLANTA GAS MINI-TABLETS IF THE BREAKAWAY BAND ON TOP OF CONTAINER IS BROKEN OR MISSING.


  1. Mylanta is a registered trademark of McNeil Consumer Pharmaceuticals Co.

Patent pending

infirst +

HEALTHCARE

Manufactured for:

Infirst Healthcare Inc.

Westport, CT 06880

©2016 Infirst Healthcare Inc.

Mylanta.com

KEEP OUTER PACKAGING FOR COMPLETE LABELING

Mylanta GAS Minis 50 tablets Assorted Flavor
Mylanta GAS Minis 50 tablets Assorted Flavor

Package level for 60 chewable tablets

SPL UNCLASSIFIED SECTION

MYLGAF60FC MYLANTA GAS RELIEF
MYLGAF60FC MYLANTA GAS RELIEF

Mylanta Pouch Pack Label

SPL UNCLASSIFIED SECTION

Mylanta Mini Pouch Pack 3 Mini Tablets
Mylanta Mini Pouch Pack 3 Mini Tablets

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
314221simethicone 125 MG Chewable TabletPSN5
314221simethicone 125 MG Chewable TabletSCD5

DailyMed Pharmacologic Classes#

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
62372-801-03Mylanta Gas Minis Assorted Fruit Flavor3 in 1 POUCHTABLET, CHEWABLE35
62372-801-50Mylanta Gas Minis Assorted Fruit Flavor50 in 1 BOTTLE, PLASTICTABLET, CHEWABLE505
62372-801-60Mylanta Gas Minis Assorted Fruit Flavor60 in 1 BOTTLE, PLASTICTABLET, CHEWABLE605

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
62372-801MYLANTA GAS MINIS ASSORTED FRUIT FLAVOR (SIMETHICONE) TABLET, CHEWABLE [INFIRST HEALTHCARE INC.]5Current NDC, Legacy NDC, 3 package rows20231220_c6db9af2-d457-477d-baa9-470ddbba5905.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
62372-801-50EA - Each62372-801adf07469-eb7e-42ed-9a6c-792bc85f7b2a12021-09-07

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
62372-80162372-801-50, 62372-801-60, 62372-801-03

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 14 matching rows.

Name, UNII, Kind table
NameUNIIKind
ADIPIC ACID76A0JE0FKJIACT
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORMK679OBS311IACT
D&C RED NO. 272LRS185U6KIACT
FD&C BLUE NO. 1H3R47K3TBDIACT
FD&C YELLOW NO. 6H77VEI93A8IACT
HYDROXYPROPYL CELLULOSE (1600000 WAMW)RFW2ET671PIACT
ISOMALTS870P55O2WIACT
MAGNESIUM STEARATE70097M6I30IACT
MALTODEXTRIN7CVR7L4A2DIACT
SILICON DIOXIDEETJ7Z6XBU4IACT
SUCRALOSE96K6UQ3ZD4IACT
SUCROSEC151H8M554IACT
TRICALCIUM PHOSPHATEK4C08XP666IACT
DIMETHICONE92RU3N3Y1OACTIB

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
Mylanta Gas Minis Assorted Fruit FlavorSIMETHICONEInfirst Healthcare Inc.c6db9af2-d457-477d-baa9-470ddbba59052023-12-04WarningsExact identifier
ndc (package): 62372-801-50
ndc (package): 62372-801-60
ndc (package): 62372-801-03
ndc (product): 62372-801
ndc11 (package): 62372080103
ndc11 (package): 62372080150
ndc11 (package): 62372080160
spl id: 0bb22980-478b-bc8c-e063-6394a90a1fee
spl set id: c6db9af2-d457-477d-baa9-470ddbba5905

Reported adverse events (FAERS/openFDA)#

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