Kroger Infantss Gas Relief Dye Free Drops

Kroger Infantss Gas Relief Dye Free Drops
SPL v7
SPL
SPL Set ID 722c8226-6556-4150-9fda-91be2b31183f
Route
ORAL
Published
Effective Date 2025-08-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Dimethicone (20 mg)
Inactive Ingredients
Carboxymethylcellulose Sodium, Unspecified Anhydrous Citric Acid Microcrystalline Cellulose Polysorbate 60 Potassium Sorbate Water Sodium Benzoate Sorbitan Monostearate Sorbitol Xanthan Gum

Identifiers & Packaging

Pill Appearance
Color: white
Marketing Status
OTC MONOGRAPH DRUG Active Since 2019-07-16

Description

Simethicone 20 mg

Purpose

Antigas


Medication Information

Purpose

Antigas

Description

Simethicone 20 mg

Uses

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

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

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 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

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.

Active Ingredient (in Each 0.3 Ml)

Simethicone 20 mg


Structured Label Content

Uses

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

Purpose

Antigas

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

Other Information (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 Ingredients (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? (Comments or Questions?)

855-200-BABY

www.ComfortsForBaby.com

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.

Active Ingredient (in Each 0.3 Ml) (Active ingredient (in each 0.3 mL))

Simethicone 20 mg


Advanced Ingredient Data


Raw Label Data

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