FDA.reportPublic FDA data

TEENY TUMMY fast instant gas relief INFANT'S GAS RELIEF DROPS

Manufacturer
Akron Pharma
Effective date
2026-09-01
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
daily-update
Hydrated at
2026-09-03 03:02:17

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.

Manufactured for:

Akron Pharma, Inc.

Fairfield, NJ 07004

www.akronpharma.com

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

1122

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
71399-0041-12025-02-11C16284748780-12cef2736-b5ab-d83d-e063-dadaa90ab31fTEENY TUMMY fast instant gas relief INFANT'S GAS RELIEF DROPS
71399-0041-12025-02-11C16284748780-12cef2736-b5ab-d83d-e063-dadaa90ab31fTEENY TUMMY fast instant gas relief INFANT'S GAS RELIEF DROPS
71399-0041-12025-01-30C16284748780-12cef2736-b5ab-d83d-e063-dadaa90ab31fTEENY TUMMY fast instant gas relief INFANT'S GAS RELIEF DROPS
71399-0041-12025-01-30C16284748780-12cef2736-b5ab-d83d-e063-dadaa90ab31fTEENY TUMMY fast instant gas relief INFANT'S GAS RELIEF DROPS

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
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
71399-004171399-0041-1

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
DIMETHICONE92RU3N3Y1OACTIB
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORMK679OBS311IACT
ANHYDROUS CITRIC ACIDXF417D3PSLIACT
MICROCRYSTALLINE CELLULOSEOP1R32D61UIACT
POLYSORBATE 60CAL22UVI4MIACT
POTASSIUM SORBATE1VPU26JZZ4IACT
WATER059QF0KO0RIACT
SODIUM BENZOATEOJ245FE5EUIACT
SORBITAN MONOSTEARATENVZ4I0H58XIACT
SORBITOL506T60A25RIACT
XANTHAN GUMTTV12P4NEEIACT

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
32025-06-24full-release2026-06-01 01:05:58

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
TEENY TUMMY Gas Relief DropsSIMETHICONEAkron Pharmadcdd0daf-5ef0-4cb2-872d-89ed6e9f6d602026-09-01WarningsExact identifier
ndc (package): 71399-0041-1
ndc (product): 71399-0041
ndc11 (package): 71399004101
spl id: 5a661e89-7ee5-e3fd-e063-6294a90a24bb
spl set id: dcdd0daf-5ef0-4cb2-872d-89ed6e9f6d60

Reported adverse events (FAERS/openFDA)#

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