FDA.reportPublic FDA data

All-Family Mylanta

Manufacturer
Sportpharm LLC
Effective date
2026-04-24
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 01:54:56

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

Usesrelieves:

• 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 useif 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

Distributed by:

Sportpharm LLC

379 Van Ness Ave 1401,

Torrance, CA 90501

Relabeled by:

Enovachem PHARMACEUTICALS

Torrance, CA 90501

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

5151

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
2599608calcium carbonate 80 MG/mL / simethicone 8 MG/mL Oral SuspensionPSN2
2599608calcium carbonate 80 MG/ML / simethicone 8 MG/ML Oral SuspensionSCD2

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
87711080-88eb-65c5-b2dd-bf99e700a372Product name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
85766-051-12MylantaAll-Family Multi Symptom Stomach Remedy473 mL in 1 BOTTLELIQUID4732

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
85766-05185766-051-12
62372-520

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
SORBITOL506T60A25RIACT
GLYCERINPDC6A3C0OXIACT
SUCRALOSE96K6UQ3ZD4IACT
CALCIUM CARBONATEH0G9379FGKACTIB
DIMETHICONE92RU3N3Y1OACTIB
BENZYL ALCOHOLLKG8494WBHIACT
XANTHAN GUMTTV12P4NEEIACT
SODIUM CARBONATE45P3261C7TIACT
CARBOXYMETHYLCELLULOSE CALCIUMUTY7PDF93LIACT
D&C RED NO. 28767IP0Y5NHIACT
MICROCRYSTALLINE CELLULOSEOP1R32D61UIACT
WATER059QF0KO0RIACT

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
12025-11-03monthly-update2026-06-03 17:39:37

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 All-Family Multi Symptom Stomach RemedyCALCIUM CARBONATE, SIMETHICONESportpharm LLCa70f113d-d5a3-44f5-b223-cd1b0e159e1a2026-04-24WarningsExact identifier
ndc (package): 85766-051-12
ndc (product): 85766-051
ndc11 (package): 85766005112
spl id: 502eda43-c27e-2ac7-e063-6294a90af902
spl set id: a70f113d-d5a3-44f5-b223-cd1b0e159e1a
Mylanta All-Family Multi Symptom Stomach RemedyCALCIUM CARBONATE, SIMETHICONEInfirst Healthcare Inc.19118884-2016-e86e-e063-6294a90a370c2024-05-22WarningsExact identifier
ndc (product): 62372-520

Reported adverse events (FAERS/openFDA)#

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