Simethicone (ENFIT) Oral Suspension, USP

Manufacturer
Everpharm LLC
Effective date
2026-09-02
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
daily-update
Hydrated at
2026-09-05 01:01:09

Label at a glance#

ProductSimethicone Drops
Active ingredientDIMETHICONE
Label structure10 sections

Dosage and administration

dose may be repeated as needed, after meals and at bedtime, or as directed by a physician only use the unit dose filled syringe.  do not exceed 12 doses per day dosage can also be mixed with 1 oz. of cool water, infant formula or other suitable liquids discard syringe after use Age (years) Weight (lbs)  Dose   children (age 2 and over)   24 and over  0.6 mL

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient (in each 0.6 mL unit-dose syringe)

OTC - ACTIVE INGREDIENT SECTION

Simethicone 40 mg

Purpose

OTC - PURPOSE SECTION

Antigas

Use

INDICATIONS & USAGE SECTION

relieves the symptoms referred to as gas

Warnings

WARNINGS SECTION

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

In case of overdose, get medical help or contact a poison control center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

  • dose may be repeated as needed, after meals and at bedtime, or as directed by a physician
  • only use the unit dose filled syringe. 
  • do not exceed 12 doses per day
  • dosage can also be mixed with 1 oz. of cool water, infant formula or other suitable liquids
  • discard syringe after use
Age (years)Weight (lbs) Dose 
 children (age 2 and over)  24 and over 0.6 mL

Other information

SPL UNCLASSIFIED SECTION

  • TAMPER-EVIDENT: Do not use if wrapper containing syringe is torn or open
  • store at room temperature 20º-25ºC (68º-77ºF)
  • do not freeze

Inactive ingredients

INACTIVE INGREDIENT SECTION

carboxymethylcellulose sodium, citric acid, flavor, maltitol, microcrystalline cellulose, purified water, sodium benzoate, sodium citrate, xanthan gum

Questions or comments?

OTC - QUESTIONS SECTION

1-866-838-3774

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 84415-003-01

Simethicone (ENFIT)

Oral Suspension, USP

40 mg/0.6 mL

Distributed by:

Everpharm LLC

Marlborough MA 01752

50 UNITS x 0.6 mL

pdppdp

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130384415003017GTIN-13: 0384415003017
EAN-13: 0384415003017
GTIN-12: 384415003017
UPC-A: 384415003017
GTIN storage (14 digits): 00384415003017
simethiconepdp.jpg

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 10 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
84415-00384415-003-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 9 matching rows.

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
12026-09-01daily-update2026-09-03 03:02:06

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
Simethicone DropsSIMETHICONE DROPSEverpharm LLC5a6d2c1f-4067-969f-e063-6394a90aa83f2026-09-02WarningsExact identifier
ndc (package): 84415-003-01
ndc (product): 84415-003
ndc11 (package): 84415000301
spl id: 5a8782d0-df4d-f78b-e063-6394a90a6127
spl set id: 5a6d2c1f-4067-969f-e063-6394a90aa83f

Reported adverse events (FAERS/openFDA)#

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