FDA.reportPublic FDA data

Infants’ Gas Relief Drops Simethicone/Antigas 1 FL.OZ. (30 mL)

Manufacturer
DOLGENCORP INC
Effective date
2026-09-03
Label type
HUMAN OTC DRUG LABEL
Version
9
Source
daily-update
Hydrated at
2026-09-05 01:01:03

Label at a glance#

ProductInfants Gas Relief Drops
Active ingredientDIMETHICONE, UNSPECIFIED
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. ▪ Only use the enclosed syringe. Do not use any other syringe, dropper, spoon or dosing device when giving this medicine to your child. ▪ remove cap and insert syringe into the prescribed level. ▪ pull syringe up until filled to the prescribed level. If you pass the prescribed level, simply push syringe ...

Storage and handling

▪ 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

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.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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Directions

DOSAGE & ADMINISTRATION SECTION

  • shake well before using
  • find right dose on chart below. if possible, use weight to dose; otherwise use age.
  • Only use the enclosed syringe. Do not use any other syringe, dropper, spoon or dosing device when giving this medicine to your child.
  • remove cap and insert syringe into the prescribed level.
  • pull syringe up until filled to the prescribed level. If you pass the prescribed level, simply push syringe back until you have reached the desired level.

    slowly dispense the liquid into your child’s mouth (towards inner chick).

  • 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.
  • dosage can also be mixed with 1 oz. cool water, infant formula or other suitable liquids
  • replace cap tightly to maintain child resistance
  • mL= milliliter

Age (yr)

Weight (lb)

Dose( mL)

infants under 2

under 24

0.3

children over 2

over 24

0.6

Other information

STORAGE AND HANDLING 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 ingredients

INACTIVE INGREDIENT SECTION

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

Questions?

OTC - QUESTIONS SECTION

1-866-467-2748

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 55910-790-01

*Compare to active ingredient in infant’s Mylicon® Gas Relief*

Infants'

Gas Relief

Simethicone Drops / Anti-gas

  • Dye- free
  • Non-staining formula

Fast, effective relief of infants’ gas symptoms

1 FL. OZ. (30 mL)

100 doses

DISTRIBUTED BY: OLD EAST MAIN CO.

100 MISSION RIDGE

GOODLETTSVILLE, TN 37072

100% SATISFACTION GUARANTEED!

(888) 309-9030

*This product is not manufactured or distributed by Infirst Healthcare Inc., the distributor of Infants’ Mylicon® Gas Relief.

  • IMPORTANT: Keep this carton for future reference on full labeling
DG Health Infants Gas Relief Simethicone
DG Health Infants Gas Relief Simethicone

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130368163709124GTIN-13: 0368163709124
EAN-13: 0368163709124
GTIN-12: 368163709124
UPC-A: 368163709124
GTIN storage (14 digits): 00368163709124		image-01.jpg

Products#

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

DailyMed product names page 1 of 1 · 14 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
55910-79055910-790-01

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
DIMETHICONE, UNSPECIFIED92RU3N3Y1OACTIB
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIEDK679OBS311IACT
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
82025-08-22full-release2026-06-01 01:11:30

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 Relief DropsSIMETHICONEDOLGENCORP INC6b132ac0-e8eb-4199-85ad-5976558ee9c82026-09-03WarningsExact identifier
ndc (package): 55910-790-01
ndc (product): 55910-790
ndc11 (package): 55910079001
spl id: 313ca52d-8692-43e8-beb2-7b4202f8022e
spl set id: 6b132ac0-e8eb-4199-85ad-5976558ee9c8

Reported adverse events (FAERS/openFDA)#

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