FDA.reportPublic FDA data

Mylanta Maximum Strength Classic Flavor

Manufacturer
Infirst Healthcare Inc.
Effective date
2023-02-01
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:54:13

Label at a glance#

ProductMylanta Maximum Strength Classic Flavor
Active ingredientALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, DIMETHICONE
Label structure11 sections

Indications and uses

relieves: • heartburn • acid indigestion • sour stomach • upset stomach due to these symptoms • pressure and bloating commonly referred to as gas • overindulgence in food and drink

Dosage and administration

• shake well before use • adults and children 12 years and over: 2 tsp – 4 tsp (1-2 doses) between meals, at bedtime or as directed by a doctor • do not take more than 12 tsp (6 doses) in any 24-hour period • do not use the maximum dosage for more than 2 weeks • children under 12 years: ask a doctor • tsp = teaspoon

Label contents#

Full prescribing information#

Active ingredients (in each 2 tsp dose)

OTC - ACTIVE INGREDIENT SECTION

Aluminum hydroxide
(equivalent to dried gel, USP) 800 mg

Magnesium hydroxide 800 mg

Simethicone 80 mg

Purpose

OTC - PURPOSE SECTION

Antacid

Antacid

Anti-gas

Uses

INDICATIONS & USAGE SECTION

relieves:

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

Warnings

WARNINGS SECTION

Ask a doctor before use if you have

  • 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.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

In case of overdose, get medical help or contact a Poison Control Center right away at 1-800-222-1222.

Directions

DOSAGE & ADMINISTRATION SECTION

  • shake well before use
  • adults and children 12 years and over:
    2 tsp – 4 tsp (1-2 doses) between meals, at bedtime or as directed by a doctor
  • do not take more than 12 tsp (6 doses) in any 24-hour period
  • do not use the maximum dosage for more than 2 weeks
  • children under 12 years: ask a doctor
  • tsp = teaspoon

Other information

SPL UNCLASSIFIED SECTION

  • each 2 tsp dose contains: magnesium 340 mg; sodium 7 mg
  • store between 20-25°C (68-77°F), do not freeze

Inactive ingredients

INACTIVE INGREDIENT SECTION

benzyl alcohol, carboxymethylcellulose sodium, flavors, glycerin, microcrystalline cellulose, purified water, sodium carbonate, sorbitol, sucralose, xanthan gum

Questions or comment?

OTC - QUESTIONS SECTION

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

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

MYLANTA®
ANTACID
+
ANTI-GAS
Alcohol 0.2%

MAXIMUM STRENGTH

FAST HEARTBURN & GAS RELIEF ON THE GO!

SMOOTH CREAMY TASTE

CLASSIC
FLAVOUR

3.4 FL OZ (100 mL)

78034MYLLF

TAMPER-EVIDENT: DO NOT USE IF PRINTED SEAL UNDER CAP IS BROKEN OR MISSING


Mylanta is a Registered Trademark of McNeil Consumer Pharmaceuticals Co.

infirst+
HEALTHCARE
©2020 Infirst Healthcare Inc.

Mylanta.com

Manufactured for:
Infirst Healthcare Inc.
Westport, CT 06880

Mylanta Maximum Strength Classic Flavor 3.4 FL OZ
Mylanta Maximum Strength Classic Flavor 3.4 FL OZ

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 SuspensionPSN1
237870aluminum hydroxide 80 MG/ML / magnesium hydroxide 80 MG/ML / simethicone 8 MG/ML Oral SuspensionSCD1
237870aluminum hydroxide 2400 MG / magnesium hydroxide 2400 MG / dimethicone 240 MG per 30 ML Oral SuspensionSY1
237870aluminum hydroxide 400 MG / magnesium hydroxide 400 MG / simethicone 40 MG per 5 ML Oral SuspensionSY1
237870aluminum hydroxide 800 MG / magnesium hydroxide 800 MG / dimethicone 80 MG per 10 ML Oral SuspensionSY1

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
DIMETHICONE Pharmacologic Class Indexing3Indexing - Pharmacologic Class20180813
MAGNESIUM CATION Pharmacologic Class Indexing4Indexing - 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
6084a4f4-5437-c9a5-caec-5361ee075a59Product name120140508
90c5639a-61b0-88d6-ddcf-21888e94869aProduct name120140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508
9869efd7-d6dd-0665-5b67-53adbe6ef15eProduct name120140508
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
62372-500-10Mylanta Maximum Strength Classic Flavor100 mL in 1 BOTTLE, PLASTICSUSPENSION1001

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
62372-500MYLANTA MAXIMUM STRENGTH CLASSIC FLAVOR (ANTACID AND ANTI GAS ALUMINUM HYDROXIDE MAGNESIUM HYDROXIDE AND SIMETHICONE) SUSPENSION [INFIRST HEALTHCARE INC.]1Current NDC, Legacy NDC, 1 package rows20230224_23cf43f1-13d1-40e8-a0e4-213b2ab15bd3.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
62372-500-10ML - Milliliter62372-500f59d2860-2b5d-4bf8-9a6d-a088d61b2d0b12023-03-13

Products#

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

DailyMed product names page 1 of 1 · 15 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
62372-50062372-500-10

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
BENZYL ALCOHOLLKG8494WBHIACT
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIEDK679OBS311IACT
GLYCERINPDC6A3C0OXIACT
MICROCRYSTALLINE CELLULOSEOP1R32D61UIACT
WATER059QF0KO0RIACT
SODIUM CARBONATE45P3261C7TIACT
SORBITOL506T60A25RIACT
SUCRALOSE96K6UQ3ZD4IACT
XANTHAN GUMTTV12P4NEEIACT

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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Mylanta Maximum Strength Classic FlavorANTACID AND ANTI GAS ALUMINUM HYDROXIDE MAGNESIUM HYDROXIDE AND SIMETHICONEInfirst Healthcare Inc.56853b20-a2aa-4b19-a428-3dde232114c62024-12-11WarningsExact identifier
ndc (package): 62372-500-10
ndc (product): 62372-500
ndc11 (package): 62372050010
23cf43f1-13d1-40e8-a0e4-213b2ab15bd323cf43f1-13d1-40e8-a0e4-213b2ab15bd32023-02-01WarningsExact identifier
spl id: 23cf43f1-13d1-40e8-a0e4-213b2ab15bd3
spl set id: 23cf43f1-13d1-40e8-a0e4-213b2ab15bd3

Reported adverse events (FAERS/openFDA)#

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