FDA.reportPublic FDA data

kosher infants gas relief

Manufacturer
Mollec Inc | GCP Laboratories
Effective date
2026-06-04
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
monthly-update
Hydrated at
2026-07-17 21:35:26

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 only use tile enclosed dropper 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 afte...

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
  • only use tile enclosed dropper
  • 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
  • ml= milliliter
Age (years)Weight (lbs)Dose
infants (under 2)under 240.3 mL

children (2 and over)

24 and over0.6 mL

Other information

SPL UNCLASSIFIED SECTION

  • TAMPER-EVIDENT: Do not use if foil seal under the 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, flavor, maltitol, microcrystalline cellulose, purified water, simethicone emulsion, sodium benzoate, sodium citrate, xanthan gum

Questions or comments?

OTC - QUESTIONS SECTION

1-866-399-7227

Package Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

11

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
82179-00782179-007-01

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
ANHYDROUS CITRIC ACIDXF417D3PSLIACT
CARBOXYMETHYLCELLULOSE SODIUMK679OBS311IACT
MALTITOLD65DG142WKIACT
CELLULOSE, MICROCRYSTALLINEOP1R32D61UIACT
WATER059QF0KO0RIACT
SODIUM BENZOATEOJ245FE5EUIACT
SODIUM CITRATE1Q73Q2JULRIACT
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
INFANTS GAS RELIEFSIMETHICONEMollec Inc53705dbc-daca-2214-e063-6294a90a10972026-06-04WarningsExact identifier
ndc (package): 82179-007-01
ndc (product): 82179-007
ndc11 (package): 82179000701
spl id: 53703907-4d9a-8b6a-e063-6294a90a5cb3
spl set id: 53705dbc-daca-2214-e063-6294a90a1097

Reported adverse events (FAERS/openFDA)#

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