FDA.reportPublic FDA data

Cardinal Infants’ Gas Relief Simethicone Drops

Manufacturer
CARDINAL HEALTH
Effective date
2025-10-14
Label type
HUMAN OTC DRUG LABEL
Version
7
Source
full-release
Hydrated at
2026-06-01 01:39:00

Label at a glance#

ProductCardinal Health Infants Gas Relief
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 other syringe, dropper, spoon or dosing device when giving this medicine to your child. Remove cap and insert syringe into the bottle. Pull syringe up until filled to the prescribed level, simply push syringe back until you have reached the described level. Slowly d...

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 signs 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 other syringe, dropper, spoon or dosing device when giving this medicine to your child.
  • Remove cap and insert syringe into the bottle.
  • Pull syringe up until filled to the prescribed level, simply push syringe back until you have reached the described level. Slowly dispense the liquid into your child’s mouth (towards inner cheek).
  • 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 or comments?

OTC - QUESTIONS SECTION

1-866-467-2748

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

*Compare to the active ingredient in Infants’ Mylicon ®Drops

NDC 70000-0051-1

Infants’

Gas Relief Drops

Simethicone/Antigas

Dye-free

Non-staining formula

  • No Alcohol/No Saccharin
  • No Artificial Color
  • No Artificial Flavor

1 FL OZ (30 mL) 100 DOSES

Distributed by:

IMPORTANT:Keep this carton for future reference on full labeling.

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

Cardinal Health Infants Gas Relief
Cardinal Health Infants Gas Relief

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
198857simethicone 20 MG in 0.3 mL Oral SuspensionPSN7
198857simethicone 66.7 MG/ML Oral SuspensionSCD7
198857simethicone 20 MG per 0.3 ML Oral SuspensionSY7
198857simethicone 40 MG per 0.6 ML Oral SuspensionSY7

DailyMed Pharmacologic Classes#

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70000-0051-1Cardinal Health Infants Gas Relief1 in 1 CARTONSUSPENSION/ DROPS17
70000-0051-1Cardinal Health Infants Gas Relief30 mL in 1 BOTTLE, DROPPERSUSPENSION/ DROPS307

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70000-0051-1ML - Milliliter70000-0051d7d104ac-143a-4c03-8251-65384603e44b12021-03-02

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
70000-005170000-0051-1

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
62024-11-21full-release2026-06-01 00:38:32

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
Cardinal Health Infants Gas ReliefSIMETHICONECARDINAL HEALTHe0dec270-dabb-4289-b5e0-bf37f9ddcbcd2025-10-14WarningsExact identifier
ndc (package): 70000-0051-1
ndc (product): 70000-0051
ndc11 (package): 70000005101
spl id: 411c8ca0-57d6-df9e-e063-6394a90ae833
spl set id: e0dec270-dabb-4289-b5e0-bf37f9ddcbcd

Reported adverse events (FAERS/openFDA)#

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