FDA.reportPublic FDA data

TEENY TUMMY

Manufacturer
ATLANTIC BIOLOGICALS CORP
Effective date
2025-05-30
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-06-01 01:03:18

Label at a glance#

ProductTEENY TUMMY 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, 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 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 repl...

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, 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 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 24

0.3 mL

children over 2

over 24

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

Call toll-free 1-877-225-6999.

DISTRIBUTED BY:

ATLANTIC BIOLOGICALS CORP.

MIAMI, FL 33179

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image descriptionimage description

image descriptionimage description

11

image descriptionimage description

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
198857simethicone 20 MG in 0.3 mL Oral SuspensionPSN4
198857simethicone 66.7 MG/ML Oral SuspensionSCD4
198857simethicone 20 MG per 0.3 ML Oral SuspensionSY4
198857simethicone 40 MG per 0.6 ML Oral SuspensionSY4

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
17856-1141-1TEENY TUMMYGas Relief Drops120 in 1 BOX, UNIT-DOSESUSPENSION1204
17856-1141-2TEENY TUMMYGas Relief Drops120 in 1 BOX, UNIT-DOSESUSPENSION1204
17856-1141-3TEENY TUMMYGas Relief Drops120 in 1 BOX, UNIT-DOSESUSPENSION1204
17856-1141-4TEENY TUMMYGas Relief Drops120 in 1 BOX, UNIT-DOSESUSPENSION1204
17856-1141-5TEENY TUMMYGas Relief Drops2 mL in 1 SYRINGESUSPENSION24
17856-1141-5TEENY TUMMYGas Relief Drops120 in 1 BOX, UNIT-DOSESUSPENSION1204
17856-1141-6TEENY TUMMYGas Relief Drops0.3 mL in 1 SYRINGESUSPENSION0.34
17856-1141-7TEENY TUMMYGas Relief Drops0.3 mL in 1 SYRINGESUSPENSION0.34
17856-1141-8TEENY TUMMYGas Relief Drops0.6 mL in 1 SYRINGESUSPENSION0.64
17856-1141-9TEENY TUMMYGas Relief Drops0.6 mL in 1 SYRINGESUSPENSION0.64

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
17856-1141-1EA - Each17856-114153429f82-f3ec-434d-af53-609f1d520dd012025-03-04
17856-1141-2EA - Each17856-11417066e3eb-2e10-40c7-ba02-6b0eaab925d512025-03-04
17856-1141-3EA - Each17856-114153ac2e8a-9999-4f28-8486-bb05a5e265f512025-03-04
17856-1141-4EA - Each17856-114188f1a33a-5403-4e61-9245-f267d10f6d9c12025-03-04
17856-1141-5ML - Milliliter17856-11416154db0e-4846-4ec3-96f5-5c281a7a75f212026-03-17
71399-0041-1ML - Milliliter71399-0041bd63ce1b-e945-4f68-976c-8cd01a82c4a212023-10-16

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
17856-114117856-1141-6, 17856-1141-1, 17856-1141-7, 17856-1141-2, 17856-1141-8, 17856-1141-3, 17856-1141-9, 17856-1141-4, 17856-1141-5
71399-0041

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
TEENY TUMMY Gas Relief DropsSIMETHICONEAkron Pharmadcdd0daf-5ef0-4cb2-872d-89ed6e9f6d602026-09-01WarningsExact identifier
ndc (product): 71399-0041
TEENY TUMMY Gas Relief DropsSIMETHICONEATLANTIC BIOLOGICALS CORP376660a2-becb-48cf-a9f5-6a76a8b8ca702025-05-30WarningsExact identifier
ndc (package): 17856-1141-5
ndc (package): 17856-1141-2
ndc (package): 17856-1141-6
ndc (package): 17856-1141-8
ndc (package): 17856-1141-1
ndc (package): 17856-1141-9
ndc (package): 17856-1141-4
ndc (package): 17856-1141-3
ndc (package): 17856-1141-7
ndc (product): 17856-1141
ndc11 (package): 17856114106
ndc11 (package): 17856114101
ndc11 (package): 17856114108
ndc11 (package): 17856114102
ndc11 (package): 17856114105
ndc11 (package): 17856114103
ndc11 (package): 17856114109
ndc11 (package): 17856114104
ndc11 (package): 17856114107
spl id: 37b26063-ea95-7741-e063-6394a90a79a8
spl set id: 376660a2-becb-48cf-a9f5-6a76a8b8ca70

Reported adverse events (FAERS/openFDA)#

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