FDA.reportPublic FDA data

MYLICON

Manufacturer
ATLANTIC BIOLOGICALS CORP. | UNIT DOSE SOLUTIONS
Effective date
2023-05-16
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
full-release
Hydrated at
2026-05-31 23:54:58

Label at a glance#

ProductMYLICON
Active ingredientDIMETHICONE
Label structure9 sections

Dosage and administration

shake well before using all dosages may be repeated as needed, after meals and at bedtime, or as directed by a physician do not exceed 12 doses per day fill enclosed dropper to recommended dosage level anddispense liquid slowly into baby’s mouth, toward the inner cheek dosage can also be mixed with 1 oz. of cool water, infant formula or other suitable liquids clean dropper well after each use and replace original ...

Label contents#

Full prescribing information#

Active ingredient (in each 0.3 mL)

OTC - ACTIVE INGREDIENT SECTION

Simethicone 20 mg

Purpose

OTC - PURPOSE SECTION

Antigas

Use

INDICATIONS & USAGE SECTION

relieves the symptoms referred to as gas

Warnings

WARNINGS SECTION

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.

Directions

DOSAGE & ADMINISTRATION SECTION

  • shake well before using
  • all dosages may be repeated as needed, after meals and at bedtime, or as directed by a physician
  • do not exceed 12 doses per day
  • fill enclosed dropper to recommended dosage level anddispense liquid slowly into baby’s mouth, toward the inner cheek dosage can also be mixed with 1 oz. of cool water, infant formula or other suitable liquids
  • clean dropper well after each use and replace original cap on bottle
Age (years)Weight (lbs)Dose
infants (under 2)under 240.3 mL

children (2 and over)

24 and over0.6 mL

Other information

SPL UNCLASSIFIED SECTION

  • TAMPER-EVIDENT: Do not use if foil seal under the cap is broken or punctured.
  • store at room temperature
  • do not freeze
  • see bottom panel for lot number and expiration date

Inactive ingredients

INACTIVE INGREDIENT SECTION

carboxymethylcellulose sodium, citric acid, flavor, maltitol, microcrystalline cellulose, purified water, sodium benzoate, sodium citrate, xanthan gum

Questions or comments?

OTC - QUESTIONS SECTION

1-800-540-3765

DISTRIBUTED BY:

ATLANTIC BIOLOGICALS CORP.

MIAMI, FL 33179

Package Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image 1image 1

image 2image 2

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
DIMETHICONE Pharmacologic Class Indexing3Indexing - Pharmacologic Class20180813

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
17856-0799-12025-01-30C16284748780-12cef2736-7819-d83d-e063-dadaa90ab31fhst infants gas relief
17856-0799-22025-01-30C16284748780-12cef2736-7819-d83d-e063-dadaa90ab31fhst infants gas relief
17856-0799-32025-01-30C16284748780-12cef2736-7819-d83d-e063-dadaa90ab31fhst infants gas relief
17856-0799-42025-01-30C16284748780-12cef2736-7819-d83d-e063-dadaa90ab31fhst infants gas relief
17856-0799-52025-01-30C16284748780-12cef2736-7819-d83d-e063-dadaa90ab31fhst infants gas relief

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
17856-0799-1MYLICON0.3 mL in 1 SYRINGESUSPENSION0.35
17856-0799-1MYLICON120 in 1 BOX, UNIT-DOSESUSPENSION1205
17856-0799-2MYLICON0.3 mL in 1 SYRINGESUSPENSION0.35
17856-0799-2MYLICON120 in 1 BOX, UNIT-DOSESUSPENSION1205
17856-0799-3MYLICON120 in 1 BOX, UNIT-DOSESUSPENSION1205
17856-0799-3MYLICON0.6 mL in 1 SYRINGESUSPENSION0.65
17856-0799-4MYLICON0.6 mL in 1 SYRINGESUSPENSION0.65
17856-0799-4MYLICON120 in 1 BOX, UNIT-DOSESUSPENSION1205
17856-0799-5MYLICON1.2 mL in 1 SYRINGESUSPENSION1.25
17856-0799-5MYLICON60 in 1 BOX, UNIT-DOSESUSPENSION605

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
17856-0799MYLICON (SIMETHICONE) SUSPENSION [ATLANTIC BIOLOGICALS CORP.]510 package rows20230517_e47eca0a-4678-4c72-97f0-144e6aa06520.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
17856-0799-2EA - Each17856-07996231fff9-6087-44e2-b869-95ac1f053ff412024-01-04
17856-0799-3EA - Each17856-0799fbb331c3-c318-4d75-87cf-f9a495d5411412023-10-16
57896-798-01ML - Milliliter57896-798d72edace-6ef1-4c1e-b1a3-721cc68c1f6312019-04-11

Products#

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

DailyMed product names page 1 of 1 · 11 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
17856-079917856-0799-1, 17856-0799-2, 17856-0799-3, 17856-0799-4, 17856-0799-5
57896-798

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 9 matching rows.

Name, UNII, Kind table
NameUNIIKind
ANHYDROUS CITRIC ACIDXF417D3PSLIACT
CARBOXYMETHYLCELLULOSE SODIUMK679OBS311IACT
MALTITOLD65DG142WKIACT
CELLULOSE, MICROCRYSTALLINEOP1R32D61UIACT
WATER059QF0KO0RIACT
SODIUM BENZOATEOJ245FE5EUIACT
SODIUM CITRATE1Q73Q2JULRIACT
XANTHAN GUMTTV12P4NEEIACT
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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
INFANTS GAS RELIEFSIMETHICONEGeri-Care Pharmaceuticals, Corp5e08709c-846a-7f13-e053-2991aa0a09a62023-11-01WarningsExact identifier
ndc (product): 57896-798
eb3941c1-96e7-4bf4-9baf-d18398829439e47eca0a-4678-4c72-97f0-144e6aa065202023-05-16WarningsExact identifier
spl id: eb3941c1-96e7-4bf4-9baf-d18398829439
spl set id: e47eca0a-4678-4c72-97f0-144e6aa06520

Reported adverse events (FAERS/openFDA)#

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