FDA.reportPublic FDA data

Infants Gas Relief

Manufacturer
Atlantic Biologicals Corps
Effective date
2021-06-30
Label type
HUMAN OTC DRUG LABEL
Version
7
Source
full-release
Hydrated at
2026-05-31 23:41:10

Label at a glance#

ProductInfants Gas Relief
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 and dispense liquid slowly into baby's mouth, toward 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 ca...

Storage and handling

TAMPER-EVIDENT: Do not use if foil seal under cap is broken or missing. 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

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 and dispense liquid slowly into baby's mouth, toward 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

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 foil seal under cap is broken or missing.
  • 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, maltitol, microcrystalline cellulose, flavor, purified water, sodium benzoate, sodium citrate, xanthan gum

Questions or comments?

OTC - QUESTIONS SECTION

(800)616-2471

HOW SUPPLIED

HOW SUPPLIED SECTION

Product: 17856-5894

NDC: 17856-5894-1 10 mL in a CUP

NDC: 17856-5894-4 1.2 mL in a DOSE PACK / 60 in a CASE

INFANTS GAS RELIEF (SIMETHICONE) SUSPENSION/ DROPS

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image descriptionimage description

image descriptionimage description

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
198857simethicone 20 MG in 0.3 mL Oral SuspensionPSN7
198857simethicone 66.7 MG/ML Oral SuspensionSCD7
198857simethicone 20 MG per 0.3 ML Oral SuspensionSY7
198857simethicone 40 MG per 0.6 ML Oral SuspensionSY7

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
17856-5894-12023-01-30C16284748780-19d75b9d0-0bcb-f424-e053-dadaa90a57ceMAJOR INFANT GAS RELIEF
17856-5894-22023-01-30C16284748780-19d75b9d0-0bcb-f424-e053-dadaa90a57ceMAJOR INFANT GAS RELIEF
17856-5894-32023-01-30C16284748780-19d75b9d0-0bcb-f424-e053-dadaa90a57ceMAJOR INFANT GAS RELIEF
17856-5894-42023-01-30C16284748780-19d75b9d0-0bcb-f424-e053-dadaa90a57ceMAJOR INFANT GAS RELIEF
17856-5894-62023-01-30C16284748780-19d75b9d0-0bcb-f424-e053-dadaa90a57ceMAJOR INFANT GAS RELIEF
17856-5894-72023-01-30C16284748780-19d75b9d0-0bcb-f424-e053-dadaa90a57ceMAJOR INFANT GAS RELIEF
17856-5894-12021-06-30C16284748780-19d75b9d0-0bcb-f424-e053-dadaa90a57ceMAJOR INFANT GAS RELIEF
17856-5894-32021-06-30C16284748780-19d75b9d0-0bcb-f424-e053-dadaa90a57ceMAJOR INFANT GAS RELIEF
17856-5894-42021-06-30C16284748780-19d75b9d0-0bcb-f424-e053-dadaa90a57ceMAJOR INFANT GAS RELIEF
17856-5894-72021-06-30C16284748780-19d75b9d0-0bcb-f424-e053-dadaa90a57ceMAJOR INFANT GAS RELIEF
17856-5894-12020-01-31C16284748780-19d75b9d0-0bcb-f424-e053-dadaa90a57ceMAJOR INFANT GAS RELIEF
17856-5894-32020-01-31C16284748780-19d75b9d0-0bcb-f424-e053-dadaa90a57ceMAJOR INFANT GAS RELIEF
17856-5894-42020-01-31C16284748780-19d75b9d0-0bcb-f424-e053-dadaa90a57ceMAJOR INFANT GAS RELIEF
17856-5894-72020-01-31C16284748780-19d75b9d0-0bcb-f424-e053-dadaa90a57ceMAJOR INFANT GAS RELIEF

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
17856-5894-1Infants Gas Relief10 mL in 1 CUPSUSPENSION/ DROPS107
17856-5894-2Infants Gas Relief120 in 1 BOX, UNIT-DOSESUSPENSION/ DROPS1207
17856-5894-2Infants Gas Relief0.6 mL in 1 SYRINGESUSPENSION/ DROPS0.67
17856-5894-3Infants Gas Relief.3 mL in 1 SYRINGESUSPENSION/ DROPS.37
17856-5894-4Infants Gas Relief60 in 1 CASESUSPENSION/ DROPS607
17856-5894-4Infants Gas Relief1.2 mL in 1 DOSE PACKSUSPENSION/ DROPS1.27
17856-5894-6Infants Gas Relief120 in 1 BOX, UNIT-DOSESUSPENSION/ DROPS1207
17856-5894-6Infants Gas Relief0.6 mL in 1 SYRINGESUSPENSION/ DROPS0.67
17856-5894-7Infants Gas Relief120 in 1 BOX, UNIT-DOSESUSPENSION/ DROPS1207
17856-5894-7Infants Gas Relief.3 mL in 1 SYRINGESUSPENSION/ DROPS.37

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
17856-5894INFANTS GAS RELIEF (SIMETHICONE) SUSPENSION/ DROPS [ATLANTIC BIOLOGICALS CORPS]7Legacy NDC, 10 package rows20210701_fa869550-a0a8-4359-8d23-d2d178090549.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0904-5894-30ML - Milliliter0904-5894c22c2221-fc84-4c4e-abc3-3718d57d40af12012-07-24

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
17856-589417856-5894-4, 17856-5894-1, 17856-5894-3, 17856-5894-7, 17856-5894-2, 17856-5894-6
0904-5894

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
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORMK679OBS311IACT
ANHYDROUS CITRIC ACIDXF417D3PSLIACT
MALTITOLD65DG142WKIACT
MICROCRYSTALLINE CELLULOSEOP1R32D61UIACT
WATER059QF0KO0RIACT
SODIUM BENZOATEOJ245FE5EUIACT
ANHYDROUS TRISODIUM CITRATERS7A450LGAIACT
XANTHAN GUMTTV12P4NEEIACT
DIMETHICONE92RU3N3Y1OACTIB

Source Document#

Source XML · Source PDF

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
02bce983-fd0b-4992-8889-9d988bdb7133fa869550-a0a8-4359-8d23-d2d1780905492021-06-30WarningsExact identifier
spl id: 02bce983-fd0b-4992-8889-9d988bdb7133
spl set id: fa869550-a0a8-4359-8d23-d2d178090549

Reported adverse events (FAERS/openFDA)#

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