FDA.reportPublic FDA data

Mylicon Infants Gas Relief Dye Free

Manufacturer
Infirst Healthcare
Effective date
2024-01-01
Label type
HUMAN OTC DRUG LABEL
Version
6
Source
full-release
Hydrated at
2026-06-01 00:06:57

Label at a glance#

ProductMylicon Infants Gas Relief Dye Free
Active ingredientDIMETHICONE
Label structure9 sections

Indications and uses

relieves the discomfort of infant gas frequently caused by air swallowing or certain formulas or foods

Dosage and administration

shake well before using find right dose on chart below. If possible, use weight to dose; otherwise, use age. only use the enclosed syringe. Do not use other syringe, dropper, spoon or dosing device when giving this medicine to your child. remove cap and insert syringe into the bottle pull syringe up until filled to the prescribed level. If you pass the prescribed level, simply push syringe back until you have reac...

Storage and handling

tamper evident: do not use if printed seal under cap is broken or missing store between 20-25°C (68-77°F) do not freeze see bottom panel for lot number and expiration date

Label contents#

Full prescribing information#

Active ingredient (in each 0.3 mL)

OTC - ACTIVE INGREDIENT SECTION

Simethicone 20 mg

Purpose

OTC - PURPOSE SECTION

Antigas

Uses

INDICATIONS & USAGE SECTION

relieves the discomfort of infant gas frequently caused by air swallowing or certain formulas or foods

Warnings

WARNINGS SECTION

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Overdose warning: In case of overdose get medical help or contact a Poison Control Center right away at 1-800-222-1222. Quick medical attention is critical even if you do not notice any signs or symptoms.

Directions

DOSAGE & ADMINISTRATION SECTION

  • shake well before using
  • find right dose on chart below. If possible, use weight to dose; otherwise, use age.
  • only use the enclosed syringe. Do not use other syringe, dropper, spoon or dosing device when giving this medicine to your child.
  • remove cap and insert syringe into the bottle
  • pull syringe up until filled to the prescribed level. If you pass the prescribed level, simply push syringe back until you have reached the desired level. Slowly dispense the liquid into your child’s mouth (toward inner cheek).
  • 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.
  • dosage can also be mixed with 1 oz. cool water, infant formula or other suitable liquids
  • replace cap tightly to maintain child resistance
  • mL = milliliter

Age (yr)

Weight (lb)

Dose (mL)

infants under 2

under 24

0.3

children over 2

over 24

0.6

Other information

STORAGE AND HANDLING SECTION

  • tamper evident: do not use if printed seal under cap is broken or missing
  • store between 20-25°C (68-77°F)
  • do not freeze
  • see bottom panel for lot number and expiration date

Inactive ingredients

INACTIVE INGREDIENT SECTION

carboxymethylcellulose sodium, citric acid, microcrystalline cellulose, natural flavors, polysorbate 60, potassium sorbate, purified water, sodium benzoate, sorbitan monostearate, sorbitol, xanthan gum

Questions or comments ?

OTC - QUESTIONS SECTION

Call 1-855-848-3284 toll free (English and Spanish)

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Mylicon® Infants' Drops

Simethicone-Antigas

Gas Relief

Gently breaks down baby’s gas bubbles

Dye Free Drops

Non-staining

Safe enough to use at every feeding and up to 12 times per day*

#1 Brand

Recommended by Pediatricians

Visit us at mylicon.com

No Alcohol

No Artificial Flavors

No Saccharin

Gluten Free

Safe enough to use at every feeding and up to 12 times per day*

Safe enough for even the newest of newborns

*use as directed

Mylicon is a registered trademark of McNeil Consumer Pharmaceuticals Co.

Important: Keep this carton for future reference on full labeling

Manufactured for

infirst Healthcare Inc.

Westport, CT 06880

©2015 infirst Healthcare Inc.

MYLICON ARTWORK 100 DOESE

Infants Mylicon Gas Relief 100 DosesInfants Mylicon Gas Relief 100 Doses

MYLICON ARTWORK 50 DOESE

SPL UNCLASSIFIED SECTION

Infants Mylicon Gas Relief 50 Doses
Infants Mylicon Gas Relief 50 Doses

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
809376MYLICON 20 MG in 0.3 mL Oral SuspensionPSN6
198857simethicone 20 MG in 0.3 mL Oral SuspensionPSN6
809376simethicone 66.7 MG/ML Oral Suspension [Mylicon]SBD6
198857simethicone 66.7 MG/ML Oral SuspensionSCD6
809376Mylicon 20 MG per 0.3 ML Oral SuspensionSY6
809376Mylicon 66.7 MG/ML Oral SuspensionSY6
198857simethicone 20 MG per 0.3 ML Oral SuspensionSY6
198857simethicone 40 MG per 0.6 ML Oral SuspensionSY6

DailyMed Pharmacologic Classes#

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

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906Product name720210625
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
6084a4f4-5437-c9a5-caec-5361ee075a59Product name120140508
90c5639a-61b0-88d6-ddcf-21888e94869aProduct name120140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
62372-650-15Mylicon Infants Gas Relief Dye Free15 mL in 1 BOTTLE, DROPPEREMULSION156
62372-650-15Mylicon Infants Gas Relief Dye Free1 in 1 CARTONEMULSION16
62372-650-30Mylicon Infants Gas Relief Dye Free1 in 1 CARTONEMULSION16
62372-650-30Mylicon Infants Gas Relief Dye Free30 mL in 1 BOTTLE, DROPPEREMULSION306

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
62372-650MYLICON INFANTS GAS RELIEF DYE FREE (SIMETHICONE) EMULSION [INFIRST HEALTHCARE]6Current NDC, Legacy NDC, 4 package rows20240111_3324139a-ed22-43af-859d-e7af19a24ee9.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
62372-650-30ML - Milliliter62372-650d8654477-8b19-44cf-8e5d-da978627b62912021-10-08

Products#

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

DailyMed product names page 1 of 1 · 13 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
62372-65062372-650-30, 62372-650-15

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 11 matching rows.

Name, UNII, Kind table
NameUNIIKind
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORMK679OBS311IACT
ANHYDROUS CITRIC ACIDXF417D3PSLIACT
MICROCRYSTALLINE CELLULOSEOP1R32D61UIACT
POLYSORBATE 60CAL22UVI4MIACT
POTASSIUM SORBATE1VPU26JZZ4IACT
WATER059QF0KO0RIACT
SODIUM BENZOATEOJ245FE5EUIACT
SORBITAN MONOSTEARATENVZ4I0H58XIACT
SORBITOL506T60A25RIACT
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 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Mylicon Infants Gas Relief Dye FreeSIMETHICONEInfirst Healthcare3324139a-ed22-43af-859d-e7af19a24ee92024-01-01WarningsExact identifier
ndc (package): 62372-650-15
ndc (package): 62372-650-30
ndc (product): 62372-650
ndc11 (package): 62372065030
ndc11 (package): 62372065015
spl id: 0bb1b812-762c-9bc2-e063-6394a90a79d2
spl set id: 3324139a-ed22-43af-859d-e7af19a24ee9

Reported adverse events (FAERS/openFDA)#

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