FDA.reportPublic FDA data

Mylanta Coat and Cool

Manufacturer
INFIRST HEALTHCARE INC.
Effective date
2024-01-01
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 00:06:58

Label at a glance#

ProductMylanta Coat and Cool
Active ingredientCALCIUM CARBONATE, MAGNESIUM HYDROXIDE, DIMETHICONE
Label structure9 sections

Indications and uses

relieves: acid indigestion heartburn 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 using Measure with dosing cup provided adults and children12 years and over: take 10-20 mL (1-2 doses) between meals, at bedtime, or as directed by a doctor do not take more than 60 mL in 24 hours period do not use the maximum dosage for more than 2 weeks children under 12 years: ask a doctor mL- milliliter

Storage and handling

each 10 mL dose contains: calcium 480 mg; magnesium 115 mg; sodium 4 mg store between 20-25°C (68-77°F), do not freeze.

Label contents#

Full prescribing information#

Active ingredient (in 10 mL dose)

OTC - ACTIVE INGREDIENT SECTION

Calcium Carbonate 1200 mg

Magnesium Hydroxide 270 mg

Simethicone 80 mg

Purpose

OTC - PURPOSE SECTION

Antacid

Antacid

Anti-gas

Uses

INDICATIONS & USAGE SECTION

  • relieves:
    • acid indigestion
    • heartburn
    • 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

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 using
  • Measure with dosing cup provided
  • adults and children12 years and over:take 10-20 mL (1-2 doses) between meals, at bedtime, or as directed by a doctor
  • do not take more than 60 mL in 24 hours period
  • do not use the maximum dosage for more than 2 weeks
  • children under 12 years:ask a doctor
  • mL-milliliter

Other information

STORAGE AND HANDLING SECTION

  • each 10 mL dose contains:calcium 480 mg; magnesium 115 mg; sodium 4 mg
  • store between 20-25°C (68-77°F), do not freeze.

Inactive ingredients

INACTIVE INGREDIENT SECTION

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

Questions or comments?

OTC - QUESTIONS SECTION

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

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Mylanta ®

NDC# 62372-796-12

NEW! Coat & Cool™

2X COATING POWER

CHOCOLATE MINT FLAVOR

WORKS ON CONTACT!

Coats & cools to relieve heartburn fast

Smooth chalky taste

12 FL OZ (355 mL)

TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL AROUND OR UNDER CAP IS BROKEN OR MISSING.

Mylanta® is Registered Trademark of McNeil Consumer Pharmaceuticals Co.

Infirst

HEALTHCARE

Manufactured for:

Infirst Healthcare Inc.

Westport, CT 06880

© 2019 Infirst Healthcare Inc.

Mylanta.com

Mylanta Coat & Cool Chocolate Mint Flavor
Mylanta Coat & Cool Chocolate Mint Flavor

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
2281844calcium carbonate 1200 MG / magnesium hydroxide 270 MG / simethicone 80 MG in 10 mL Oral SuspensionPSN3
2281844calcium carbonate 120 MG/ML / magnesium hydroxide 27 MG/ML / simethicone 8 MG/ML Oral SuspensionSCD3
2281844calcium carbonate 1200 MG / magnesium hydroxide 270 MG / simethicone 80 MG per 10 ML Oral SuspensionSY3

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
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e0d2eb29-08bd-4bba-90d1-c91c68a38767Product name420250516
30b0ac6e-02aa-0e5c-0d8b-cffdf3a282b2Product name520250304
334fe8d2-68fb-4331-a576-420e302ec069Product name720240320
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
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
e92765c1-be81-432a-b909-1b10777ec378Product name120190208
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
0441a8f5-3835-497c-aedd-bc78cba56b2aProduct name120150317
87711080-88eb-65c5-b2dd-bf99e700a372Product name120140508
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
62372-796-12Mylanta Coat and Cool355 mL in 1 BOTTLE, PLASTICLIQUID3553

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
62372-796MYLANTA COAT AND COOL (CALCIUM CARBONATE, MAGNESIUM HYDROXIDE, SIMETHICONE) LIQUID [INFIRST HEALTHCARE INC.]3Current NDC, Legacy NDC, 1 package rows20240111_b6571f7f-e1ea-4034-a46c-4de1d01beec3.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
62372-796-12ML - Milliliter62372-7964b008be4-a344-43f0-9d71-801ca3e3e16912022-04-06

Products#

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

DailyMed product names page 1 of 1 · 19 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
62372-79662372-796-12

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
BENZYL ALCOHOLLKG8494WBHIACT
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORMK679OBS311IACT
GLYCERINPDC6A3C0OXIACT
MICROCRYSTALLINE CELLULOSEOP1R32D61UIACT
PECTIN89NA02M4RXIACT
WATER059QF0KO0RIACT
SODIUM CARBONATE45P3261C7TIACT
SORBITOL506T60A25RIACT
SUCRALOSE96K6UQ3ZD4IACT
SUCROSEC151H8M554IACT
XANTHAN GUMTTV12P4NEEIACT
CALCIUM CARBONATEH0G9379FGKACTIB
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 Coat and CoolCALCIUM CARBONATE, MAGNESIUM HYDROXIDE, SIMETHICONEINFIRST HEALTHCARE INC.b6571f7f-e1ea-4034-a46c-4de1d01beec32024-01-01WarningsExact identifier
ndc (package): 62372-796-12
ndc (product): 62372-796
ndc11 (package): 62372079612
spl id: 0bb20520-82b8-a86d-e063-6394a90ae230
spl set id: b6571f7f-e1ea-4034-a46c-4de1d01beec3

Reported adverse events (FAERS/openFDA)#

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