Infants’ Gas Relief Drops Simethicone/antigas 1 Fl.oz. (30 Ml)

Infants’ Gas Relief Drops Simethicone/antigas 1 Fl.oz. (30 Ml)
SPL v8
SPL
SPL Set ID 6b132ac0-e8eb-4199-85ad-5976558ee9c8
Route
ORAL
Published
Effective Date 2025-08-22
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

Marketing Status
OTC MONOGRAPH DRUG Active Since 2020-01-14

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.
  • 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

Questions?

1-866-467-2748

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

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
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.
  • 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

Questions?

1-866-467-2748

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

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
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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