FDA.reportPublic FDA data

Mommys Bliss Gas Relief Simethicone Drops

Manufacturer
MOM Enterprises, Inc
Effective date
2021-06-09
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
legacy-cache
Hydrated at
2026-08-01 22:43:43

Label at a glance#

ProductMommys Bliss Gas Relief Simethicone Drops
Active ingredientDIMETHICONE
Label structure8 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. 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, cool water, infant formu...

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 sign 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.
  • 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, cool water, infant formula or other suitable liquids
  • clean dropper well after each use
  • mL = milliliter 
  •  Age (yr) Weight (lb)  Dose (mL) 
     infants under 2  under 24 0.3 
     children over 2  over 24  0.6 

Other information

SPL UNCLASSIFIED SECTION

  • tamper evident: do not use if printed seal under cap is broken or missing
  • store at room temperature
  • do not freeze
  • see bottom panel for lot number and expiration date

Inactive ingredinets

INACTIVE INGREDIENT SECTION

carboxymethylcellulose sodium, citric acid, ginger extract, microcrystalline cellulose, polysorbate 60, potassium sorbate, purified water, sodium benzoate, sorbitan monostearate, sorbitol, stevia extract, xanthan gum.

Questions?

OTC - QUESTIONS SECTION

Call 1-877-457-4955

Package Labeling:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LabelLabel

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
71444-789-012025-12-23C16284748780-11030e365-27a9-111a-e063-dadaa90a10e2Mommy's Bliss Gas Relief Simethicone Drops
71444-789-012024-01-30C16284748780-11030e365-27a9-111a-e063-dadaa90a10e2Mommy's Bliss Gas Relief Simethicone Drops

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71444-789MOMMYS BLISS GAS RELIEF SIMETHICONE DROPS (DIMETHICONE) SOLUTION/ DROPS [MOM ENTERPRISES, INC]2Legacy NDC20210610_4a635119-211c-4876-9f39-d9ff08df3baa.zip

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
71444-78971444-789-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 12 matching rows.

Name, UNII, Kind table
NameUNIIKind
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORMK679OBS311IACT
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
GINGERC5529G5JPQIACT
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
43fbd38f-a1f8-a122-e063-6294a90a24384a635119-211c-4876-9f39-d9ff08df3baa2025-11-19WarningsExact identifier
spl set id: 4a635119-211c-4876-9f39-d9ff08df3baa

Reported adverse events (FAERS/openFDA)#

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