FDA.reportPublic FDA data

SIMETHICONE INFANT GAS RELIEF DROPS fast instant gas relief

Manufacturer
Atlantic Biologicals Corp.
Effective date
2026-03-19
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 01:50:48

Label at a glance#

ProductSIMETHICONE INFANT Gas Relief Drops
Active ingredientDIMETHICONE
Label structure8 sections

Indications and uses

relieves the symptoms referred to as gas

Dosage and administration

shake well before using all dosages may be repeated as needed, alter meals and at bedtime, or as directed by a physician do not exceed 12 doses per day fill enclosed dropper to recommended dosage level and dispense 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 Age (years) Weight (lbs) Dose infants (under 2) under ...

Storage and handling

TAMPER-EVIDENT : Do not use if printed seal under cap is broken or punctured store at room temperature 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 symptoms referred to as gas

Warnings

WARNINGS SECTION

Keep out of reach of children. In case of overdose get medical help or contact a Poison Control Center right away.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Directions

DOSAGE & ADMINISTRATION SECTION

  • shake well before using
  • all dosages may be repeated as needed, alter meals and at bedtime, or as directed by a physician
  • do not exceed 12 doses per day
  • fill enclosed dropper to recommended dosage level and dispense 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

Age (years)

Weight (lbs)

Dose

infants (under 2)

under 24

0.3 mL

children (2 and over)

24 and over

0.6 mL

Other information

STORAGE AND HANDLING SECTION

  • TAMPER-EVIDENT:Do not use if printed seal under 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 strawberry, Microcrystalline cellulose, Polysorbate 60, Potassium sorbate, Purified water, Sodium benzoate, Sorbitan monostearate, Sorbitol solution, Xanthan gum.

Questions or comments ?

OTC - QUESTIONS SECTION

To report SUSPECTED ADVERSE REACTIONS, contact the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch/report.htm

Distributed By:

Atlantic Biologicals Corp.

Miami, FL 33179

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

11

33

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
198857simethicone 20 MG in 0.3 mL Oral SuspensionPSN1
198857simethicone 66.7 MG/ML Oral SuspensionSCD1
198857simethicone 20 MG per 0.3 ML Oral SuspensionSY1
198857simethicone 40 MG per 0.6 ML Oral SuspensionSY1

DailyMed Pharmacologic Classes#

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

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeData Matrix(01)00317856101813(17)010101(10)XXXXXXXXXX(21)XXXXXXXXXXXGTIN-14: 00317856101813
GTIN-12: 317856101813
UPC-A: 317856101813
EAN-13: 0317856101813
GTIN storage (14 digits): 00317856101813		17856-1018-01 Rev. 1 Case Label.jpg
BarcodeData Matrix(01)00317856101837(17)010101(10)XXXXXXXXXX(21)XXXXXXXXXXXGTIN-14: 00317856101837
GTIN-12: 317856101837
UPC-A: 317856101837
EAN-13: 0317856101837
GTIN storage (14 digits): 00317856101837		17856-1018-03 Rev. 1 Case Label.jpg

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
17856-1018-1SIMETHICONE INFANTGas Relief Drops0.3 mL in 1 SYRINGESUSPENSION0.31
17856-1018-1SIMETHICONE INFANTGas Relief Drops60 in 1 CASESUSPENSION601
17856-1018-3SIMETHICONE INFANTGas Relief Drops60 in 1 CASESUSPENSION601
17856-1018-3SIMETHICONE INFANTGas Relief Drops3 mL in 1 SYRINGESUSPENSION31

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
17856-1018-1EA - Each17856-10183eb2ec3f-b7a9-4bf0-8ead-599d30301a2112026-05-22
17856-1018-3ML - Milliliter17856-1018da0bc226-9100-4d0e-8016-e4f64fae422c12026-05-22
82568-0017-3ML - Milliliter82568-0017b5bb14da-65f2-41ba-89f9-e1555f0e1b5612025-10-14
82568-0017-4ML - Milliliter82568-0017c1386582-32de-40f1-8f29-0a70ca9eb35e12025-11-13

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
17856-101817856-1018-3, 17856-1018-1
82568-0017

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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
SIMETHICONE INFANT Gas Relief DropsSIMETHICONEAtlantic Biologicals Corp.4d658287-358f-d358-e063-6294a90a4bd32026-03-19WarningsExact identifier
ndc (package): 17856-1018-3
ndc (package): 17856-1018-1
ndc (product): 17856-1018
ndc11 (package): 17856101801
ndc11 (package): 17856101803
spl id: 4d658648-1d31-b0fe-e063-6294a90a0ca6
spl set id: 4d658287-358f-d358-e063-6294a90a4bd3
SIMETHICONE INFANT Gas Relief DropsSIMETHICONEAARNA USA Inc.9b0fde90-35ae-498e-99cc-d120f1a871822025-07-29WarningsExact identifier
ndc (product): 82568-0017

Reported adverse events (FAERS/openFDA)#

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