FDA.reportPublic FDA data

Infants Gas Relief Drops

Manufacturer
Wal-Mart Stores,Inc.,
Effective date
2025-10-27
Label type
HUMAN OTC DRUG LABEL
Version
12
Source
full-release
Hydrated at
2026-06-01 01:40:53

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 back until...

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, flavor, microcrystalline cellulose, polysorbate 60, potassium sorbate, purified water, sodium benzoate, sorbitan monostearate, sorbitol, xanthan gum.

Questions?

OTC - QUESTIONS SECTION

1-877-307-2192

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

COMPARE TO INFANT’S MYLICON® DROPS ACTIVE INGREDIENT*

Parent’s CHOICE™

Infants'

Gas Relief

Drops

Simethicone /Antigas

No Artificial Colors, Flavors or Saccharin

Dye-Free, Non-Staining Formula

1 FL. OZ. (30 mL) 100 doses

DISTRIBUTED BY: Walmart, Bentonville, AR 72716

Made in USA with domestic and imported ingredients.

Factory certified.

Syringe Enclosed. This bottle contains 100 doses (0.3mL/dose)

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

  • IMPORTANT: Keep this carton for future reference on full labeling
Infant's Gas Relief Drop Simethicone Antigas
Infant's Gas Relief Drop Simethicone Antigas

Infants Gas Relief Drops

SPL UNCLASSIFIED SECTION

Infants Gas Relief Drop
Infants Gas Relief Drop

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
198857simethicone 20 MG in 0.3 mL Oral SuspensionPSN12
198857simethicone 66.7 MG/ML Oral SuspensionSCD12
198857simethicone 20 MG per 0.3 ML Oral SuspensionSY12
198857simethicone 40 MG per 0.6 ML Oral SuspensionSY12

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
DIMETHICONE Pharmacologic Class Indexing3Indexing - Pharmacologic Class20180813

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130681131135184GTIN-13: 0681131135184
EAN-13: 0681131135184
GTIN-12: 681131135184
UPC-A: 681131135184
GTIN storage (14 digits): 00681131135184		image-01.jpg
BarcodeEAN-130681131769433GTIN-13: 0681131769433
EAN-13: 0681131769433
GTIN-12: 681131769433
UPC-A: 681131769433
GTIN storage (14 digits): 00681131769433		70901-S-WMTFC artwork.png.jpg

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
49035-709-01Infants Gas Relief Drops1 in 1 CARTONEMULSION112
49035-709-01Infants Gas Relief Drops30 mL in 1 BOTTLEEMULSION3012
49035-709-30Infants Gas Relief Drops30 mL in 1 BOTTLEEMULSION3012
49035-709-30Infants Gas Relief Drops1 in 1 CARTONEMULSION112

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
49035-709-30ML - Milliliter49035-709ac900725-9928-443a-b64d-14e2b7d42dbf12023-03-13

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
49035-70949035-709-01, 49035-709-30

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
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIEDK679OBS311IACT
ANHYDROUS CITRIC ACIDXF417D3PSLIACT
MICROCRYSTALLINE CELLULOSEOP1R32D61UIACT
POLYSORBATE 60CAL22UVI4MIACT
POTASSIUM SORBATE1VPU26JZZ4IACT
WATER059QF0KO0RIACT
SODIUM BENZOATEOJ245FE5EUIACT
SORBITAN MONOSTEARATENVZ4I0H58XIACT
SORBITOL506T60A25RIACT
XANTHAN GUMTTV12P4NEEIACT
DIMETHICONE, UNSPECIFIED92RU3N3Y1OACTIB

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
112024-11-15full-release2026-06-01 00:37:30

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 DropsSIMETHICONEWal-Mart Stores,Inc.,966f0506-c2d2-4d3c-bd2d-c5a6b1e0a1572025-10-27WarningsExact identifier
ndc (package): 49035-709-30
ndc (package): 49035-709-01
ndc (product): 49035-709
ndc11 (package): 49035070901
ndc11 (package): 49035070930
spl id: 42223d4a-ac52-c3c5-e063-6394a90a3723
spl set id: 966f0506-c2d2-4d3c-bd2d-c5a6b1e0a157

Reported adverse events (FAERS/openFDA)#

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