Mylanta

Manufacturer
Infirst Healthcare Inc.
Effective date
2024-05-22
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 00:12:52

Label at a glance#

ProductMylanta All-Family Multi Symptom Stomach Remedy
Active ingredientCALCIUM CARBONATE, DIMETHICONE
Label structure10 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active ingredients

(in each 10 mL dose)

Calcium carbonate 800 mg

Simethicone Emulsion 266.6 mg/ Simethicone 80 mg

OTC - PURPOSE SECTION

Purposes

Antacid

Anti-gas

INDICATIONS & USAGE SECTION

Uses relieves:

• heartburn • acid indigestion • sour stomach

• upset stomach due to thse symptoms

• pressure and bloating commonly referred to as gas

• overindulgence in food and drink

WARNINGS SECTION

Warnings

OTC - ASK DOCTOR/PHARMACIST SECTION

Ask a doctor or pharmacist before use if you are presently taking a prescription drug. Antacids may interact with certain prescription drugs.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. In case of overdose, get medical help or contact a poison control center right away at 1-800-222-1222.

DOSAGE & ADMINISTRATION SECTION

Directions

• shake well before use • measure with dosing cup provided

• take as needed, between meals, at bedtime or as directed by a doctor

• do not use the maximum dosage for more than 2 weeks

• follow directions based on age below

AgeDosage
children ages 6-11 yrs10 mL. Not to exceed more than 30 mL in 24 hours
adults and children 12 yrs of age and over10-20 mL. Not to exceed more than 60 mL in 24 hours

• mL=milliliter

Other information

SPL UNCLASSIFIED SECTION

• each 10 mL dose contains:

calcium 320 mg; sodium 5 mg

• store between 20-25°C (68-77°F), do not freeze

INACTIVE INGREDIENT SECTION

Inactive ingredients

benzyl alcohol, carboxymethylcellulose sodium, D&C red no. 28, flavor, glycerin, microcrystalline cellulose, purified water, sodium carbonate, sorbitol, sucralose, xanthan gum

OTC - QUESTIONS SECTION

Questions or comments? call 1-844-695-6624

toll free (English and Spanish)

SPL UNCLASSIFIED SECTION

Great-tasting

All-Family Mylanta ®

QUICKLY SOOTHES for fast relief

MULTI-SYMPTOM RELIEF

of heartburn, gas, and upset stomachs

due to overindulgence in food and drink

GREAT-TASTING mixed berry flavor

ACTIVE INGREDIENTS:

CALCIUM CARBONATE, SIMETHICONE

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

infirst + ™

Manufactured for:

Infirst Healthcare Inc.

Westport, CT 06880

2024 Infirst Healthcare Inc.

©Mylanta.com

Lot:

Exp:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

VALUE SIZE

ALL-FAMILY

Mylanta ®

ANTACID+ANTI-GAS

MULTI-SYMPTOM

STOMACH REMEDY

Fast Relief of Heartburn,

Gas, and Upset Stomachs

for Adults & Children

Ages 6+

MIXED BERRY FLAVOR

16 FL OZ (473 mL)

labellabel

drug factsdrug facts

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
2599608calcium carbonate 80 MG/mL / simethicone 8 MG/mL Oral SuspensionPSN1
2599608calcium carbonate 80 MG/ML / simethicone 8 MG/ML Oral SuspensionSCD1

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
CALCIUM CATION Pharmacologic Class Indexing3Indexing - Pharmacologic Class20230427
DIMETHICONE Pharmacologic Class Indexing3Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
bee4fa8d-8d82-423a-a0b5-40a89dd13a99Product name120250618
e0d2eb29-08bd-4bba-90d1-c91c68a38767Product name420250516
30b0ac6e-02aa-0e5c-0d8b-cffdf3a282b2Product name520250304
334fe8d2-68fb-4331-a576-420e302ec069Product name720240320
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
e92765c1-be81-432a-b909-1b10777ec378Product name120190208
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
0441a8f5-3835-497c-aedd-bc78cba56b2aProduct name120150317
6084a4f4-5437-c9a5-caec-5361ee075a59Product name120140508
87711080-88eb-65c5-b2dd-bf99e700a372Product name120140508
90c5639a-61b0-88d6-ddcf-21888e94869aProduct name120140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508
9869efd7-d6dd-0665-5b67-53adbe6ef15eProduct name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
62372-520-16MylantaAll-Family Multi Symptom Stomach Remedy473 mL in 1 BOTTLELIQUID4731

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
62372-520MYLANTA ALL-FAMILY MULTI SYMPTOM STOMACH REMEDY (CALCIUM CARBONATE, SIMETHICONE) LIQUID [INFIRST HEALTHCARE INC.]1Current NDC, 1 package rows20240524_19118884-2016-e86e-e063-6294a90a370c.zip

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
62372-52062372-520-16

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 12 matching rows.

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 All-Family Multi Symptom Stomach RemedyCALCIUM CARBONATE, SIMETHICONEInfirst Healthcare Inc.19118884-2016-e86e-e063-6294a90a370c2024-05-22WarningsExact identifier
ndc (package): 62372-520-16
ndc (product): 62372-520
ndc11 (package): 62372052016
spl id: 19118884-2017-e86e-e063-6294a90a370c
spl set id: 19118884-2016-e86e-e063-6294a90a370c

Reported adverse events (FAERS/openFDA)#

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