FDA.reportPublic FDA data

Mylanta Maximum Strength Vanilla Caramel Flavor

Manufacturer
Infirst Healthcare Inc.
Effective date
2024-01-01
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-06-01 00:06:58

Label at a glance#

ProductMylanta Maximum Strength Vanilla Caramel Flavor
Active ingredientALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, DIMETHICONE
Label structure9 sections

Indications and uses

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

Dosage and administration

shake well before use measure with dosing cup provided adults and children 12 years and over : 10 mL-20 mL (1-2 doses) between meals, at bedtime or as directed by a doctor do not take more than 60 mL (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 mL= milliliter

Label contents#

Full prescribing information#

Active ingredients (in each 10 mL 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
  • pressure and bloating commonly referred to as gas
  • acid indigestion
  • sour stomach
  • upset stomach due to these symptoms
  • 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 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.

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
  • measure with dosing cup provided
  • adults and children 12 years and over: 10 mL-20 mL (1-2 doses) between meals, at bedtime or as directed by a doctor
  • do not take more than 60 mL (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
  • mL= milliliter

Other information

SPL UNCLASSIFIED SECTION

  • each 10 mL 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, caramel , carboxymethylcellulose sodium ,flavors, glycerin, microcrystalline cellulose, purified water, sodium carbonate, sorbitol, sucralose, xanthan gum

Questions or comment?

OTC - QUESTIONS SECTION

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

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

MYLANTA ®

MAXIMUM STRENGTH

LIQUID ANTACID + ANTI-GAS WORKS ON CONTACT!

          • Tough on Heartburn
          • Gentle on Your Body

SMOOTH CREAMY TASTE

Vanilla Caramel Flavor

12 FL OZ (355mL)

Also try Mylanta Maximum Strength Classic Flavor

and

Mylanta Tonight,with its soothing taste of Honey-Chamomile, is perfect for heartburn relief after dinner

and

Mylanta GasMinis-great-tasting mini- tablets that relieve gas symptoms fast

The coating, acid-neutralizing power of New Maximum Strength Mylanta® starts to work on contact.

It helps soothe and relieve heartburn, acid indigestion, and bothersome gas symptoms so you can feel better fast.

Tough on heartburn and gas, Mylanta works at the source of symptoms. It is gentle on your body with a great-tasting flavor, and can be used as directed every day.

  • Multi-symptom relief
  • Extra coating power
  • Paraben- free

Active ingredients: Aluminum hydroxide, Magnesium hydroxide, Simethicone

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

Manufactured for:

Infirst Healthcare Inc.

Westport, CT 06880

©2017 Infirst Healthcare Inc.

Mylanta.com

Mylanta Liquid Antacid and AntiGas Vanilla Caramel Flavor 12 FL OZMylanta Liquid Antacid and AntiGas Vanilla Caramel Flavor 12 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 SuspensionPSN4
237870aluminum hydroxide 80 MG/ML / magnesium hydroxide 80 MG/ML / simethicone 8 MG/ML Oral SuspensionSCD4
237870aluminum hydroxide 2400 MG / magnesium hydroxide 2400 MG / dimethicone 240 MG per 30 ML Oral SuspensionSY4
237870aluminum hydroxide 400 MG / magnesium hydroxide 400 MG / simethicone 40 MG per 5 ML Oral SuspensionSY4
237870aluminum hydroxide 800 MG / magnesium hydroxide 800 MG / dimethicone 80 MG per 10 ML Oral SuspensionSY4

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
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
62372-504-12Mylanta Maximum Strength Vanilla Caramel Flavor355 mL in 1 BOTTLE, PLASTICSUSPENSION3554

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
62372-504MYLANTA MAXIMUM STRENGTH VANILLA CARAMEL FLAVOR (ANTACID AND ANTI GAS ALUMINUM HYDROXIDE MAGNESIUM HYDROXIDE AND SIMETHICONE) SUSPENSION [INFIRST HEALTHCARE INC.]4Current NDC, Legacy NDC, 1 package rows20240111_ace5cae4-3a78-41c3-987d-59ce22dca2ac.zip

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
62372-50462372-504-12

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 13 matching rows.

Name, UNII, Kind table
NameUNIIKind
BENZYL ALCOHOLLKG8494WBHIACT
CARAMELT9D99G2B1RIACT
GLYCERINPDC6A3C0OXIACT
MICROCRYSTALLINE CELLULOSEOP1R32D61UIACT
WATER059QF0KO0RIACT
SODIUM CARBONATE45P3261C7TIACT
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORMK679OBS311IACT
SORBITOL506T60A25RIACT
SUCRALOSE96K6UQ3ZD4IACT
XANTHAN GUMTTV12P4NEEIACT
ALUMINUM HYDROXIDE5QB0T2IUN0ACTIB
MAGNESIUM HYDROXIDENBZ3QY004SACTIB
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 Maximum Strength Vanilla Caramel FlavorANTACID AND ANTI GAS ALUMINUM HYDROXIDE MAGNESIUM HYDROXIDE AND SIMETHICONEInfirst Healthcare Inc.ace5cae4-3a78-41c3-987d-59ce22dca2ac2024-01-01WarningsExact identifier
ndc (package): 62372-504-12
ndc (product): 62372-504
ndc11 (package): 62372050412
spl id: 0bb0df3b-05ce-5c5b-e063-6394a90ab91a
spl set id: ace5cae4-3a78-41c3-987d-59ce22dca2ac

Reported adverse events (FAERS/openFDA)#

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