Infants Simethicone Drops

Infants Simethicone Drops
SPL v1
SPL
SPL Set ID 6a3055bf-74ac-429b-b510-4f668f667685
Route
ORAL
Published
Effective Date 2012-05-02
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Dimethicone (63.3 mg) Silicon Dioxide (3.7 mg)
Inactive Ingredients
Carbomer Homopolymer Type B Anhydrous Citric Acid Fd&c Red No. 3 Hypromelloses Water Saccharin Sodium Sodium Benzoate Sodium Citrate

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH FINAL Active Since 2007-10-30
Description

Simethicone 20 mg

Purpose

Anti-gas

Medication Information

Purpose

Anti-gas

Description

Simethicone 20 mg

Uses

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

Section 42229-5

Made in the USA

for Qualitest Pharmaceuticals

Huntsville, AL 35811

Rev. 6/10  R6

8276455  0894





Additional barcode labeling by:

Physicians Total Care, Inc.

Tulsa, Oklahoma      74146

Directions
  • shake well before using
  • 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 to recommended dosage level and dispense liquid slowly into baby’s mouth, toward the inner cheek
  • dosage can also be mixed with 1 oz of cool water, infant formula or other suitable liquids
  • for best results, clean dropper after each use and replace original cap
Age Weight Dose
newborn  - - - - 0.3 mL
infants under 2 years under 24 lbs 0.3 mL
children over 2 years over 24 lbs 0.6 mL
Other Information
  • store at room temperature 15°- 30°C (59°- 86°F)
  • do not freeze

You may report serious side effects to: 130 Vintage Drive, Huntsville, AL 35811.

Inactive Ingredients

carbomer, citric acid, FD&C  red #3, flavor, hypromellose, purified water, saccharin sodium, sodium benzoate, sodium citrate

Principal Display Panel
Keep Out of Reach of Children.

In case of overdose, get medical help or contact a Poison Control Center right away.

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.

Section 42229-5 (42229-5)

Made in the USA

for Qualitest Pharmaceuticals

Huntsville, AL 35811

Rev. 6/10  R6

8276455  0894





Additional barcode labeling by:

Physicians Total Care, Inc.

Tulsa, Oklahoma      74146

Purpose

Anti-gas

Directions
  • shake well before using
  • 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 to recommended dosage level and dispense liquid slowly into baby’s mouth, toward the inner cheek
  • dosage can also be mixed with 1 oz of cool water, infant formula or other suitable liquids
  • for best results, clean dropper after each use and replace original cap
Age Weight Dose
newborn  - - - - 0.3 mL
infants under 2 years under 24 lbs 0.3 mL
children over 2 years over 24 lbs 0.6 mL
Other Information (Other information)
  • store at room temperature 15°- 30°C (59°- 86°F)
  • do not freeze

You may report serious side effects to: 130 Vintage Drive, Huntsville, AL 35811.

Inactive Ingredients (Inactive ingredients)

carbomer, citric acid, FD&C  red #3, flavor, hypromellose, purified water, saccharin sodium, sodium benzoate, sodium citrate

Principal Display Panel (PRINCIPAL DISPLAY PANEL)
Keep Out of Reach of Children. (Keep out of reach of children.)

In case of overdose, get medical help or contact a Poison Control Center right away.

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

Simethicone 20 mg

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:55:27.136841 · Updated: 2026-03-14T22:53:05.393026