MedPath

Infants Gas Relief

Kroger INFANTSs GAS RELIEF Dye free DROPS

Approved
Approval ID

722c8226-6556-4150-9fda-91be2b31183f

Product Type

HUMAN OTC DRUG LABEL

Effective Date

Aug 1, 2025

Manufacturers
FDA

THE KROGER CO.

DUNS: 006999528

Products 1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

Simethicone Antigas

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code30142-171
Application NumberM002
Product Classification
M
Marketing Category
C200263
G
Generic Name
Simethicone Antigas
Product Specifications
Route of AdministrationORAL
Effective DateAugust 1, 2025
FDA Product Classification

INGREDIENTS (11)

CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIEDInactive
Code: K679OBS311
Classification: IACT
ANHYDROUS CITRIC ACIDInactive
Code: XF417D3PSL
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
POLYSORBATE 60Inactive
Code: CAL22UVI4M
Classification: IACT
POTASSIUM SORBATEInactive
Code: 1VPU26JZZ4
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
SODIUM BENZOATEInactive
Code: OJ245FE5EU
Classification: IACT
SORBITAN MONOSTEARATEInactive
Code: NVZ4I0H58X
Classification: IACT
SORBITOLInactive
Code: 506T60A25R
Classification: IACT
XANTHAN GUMInactive
Code: TTV12P4NEE
Classification: IACT
DIMETHICONE, UNSPECIFIEDActive
Quantity: 20 mg in 0.3 mL
Code: 92RU3N3Y1O
Classification: ACTIB

Drug Labeling Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LOINC: 51945-4Updated: 8/1/2025

Principal Display Panel

NDC#30142-171-01

Dye Free Drops

INFANTS’ GAS RELIEF

compare to the active ingredient of**INFANTS’ MYLICON***®**DROPS

*see the side panel

Dye Free Drops

INFANTS’ GAS RELIEF

SIMETHICONE-ANTIGAS

  • Non-Staining formula
  • Gently Breaks Down Baby’s Gas Bubbles
  • No alcohol
  • No Artificial Colors or Flavor

1 Fl. OZ (30ml)

100 DOSES

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

DISTRIBUTED BY THE KROGER CO.

CINCINNATI, OHIO 45202

*THIS PRODUCT IS NOT MANUFACTURED OR DISTRIBUTED BY INFIRST HEALTHCARE INC., THE DISTRIBUTOR OF INFANTS’ MYLICON ®DROPS. INFIRST HEALTHCARE INC. IS NOT AFFILIATED WITH THE KROGER CO. OR THIS PRODUCT.

Kroger Infants Gas Relief Drops

INDICATIONS & USAGE SECTION

LOINC: 34067-9Updated: 8/1/2019

Uses

Relieves the discomfort of infant gas frequently caused by air swallowing or certain formulas or foods

OTC - ACTIVE INGREDIENT SECTION

LOINC: 55106-9Updated: 8/1/2019

Active ingredient (in each 0.3 mL)

Simethicone 20 mg

OTC - PURPOSE SECTION

LOINC: 55105-1Updated: 8/1/2019

Purpose

Antigas

WARNINGS SECTION

LOINC: 34071-1Updated: 8/1/2019

Warnings

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.

DOSAGE & ADMINISTRATION SECTION

LOINC: 34068-7Updated: 8/1/2019

Directions

*shake well before using

  • find right dose on chart below. If possible, use weight to dose; otherwise, use age.
  • 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.
  • Fill enclosed dropper or syringe to recommended dosage level and dispense liquid slowly into baby’s mouth, toward the inner cheek.Do not use other syringe, dropper, spoon or dosing device when giving this medicine to your child.
  • dosage can also be mixed with 1 oz. cool water, infant formula or other suitable liquids
  • clean dropper well after each use-recap bottle with original cap
  • mL = milliliter

Age (yr)

Weight (lb)

Dose (mL)

infants under 2

under 24

0.3

children over 2

over 24

0.6

STORAGE AND HANDLING SECTION

LOINC: 44425-7Updated: 8/1/2019

Other information

*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 INGREDIENT SECTION

LOINC: 51727-6Updated: 8/1/2019

Inactive ingredients

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

Comments or Questions?

855-200-BABY

www.ComfortsForBaby.com

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