Topco Infants Gas Relief Drops

Topco Infants Gas Relief Drops
SPL v2
SPL
SPL Set ID fd6a2537-8db2-492d-b045-6404df2fb9c3
Route
ORAL
Published
Effective Date 2024-12-26
Document Type 34390-5 Human OTC Drug Label

Drug Facts

Composition & Product

Active Ingredients
Dimethicone (20 mg)
Inactive Ingredients
Benzoic Acid Magnesium Aluminum Silicate Water Sorbitol Xanthan Gum

Identifiers & Packaging

Pill Appearance
Color: white
Marketing Status
OTC MONOGRAPH DRUG Active Since 2013-03-01
Description

Simethicone 20 mg

Purpose

Antigas

Medication Information

Purpose

Antigas

Description

Simethicone 20 mg

Use(s)

relieves the symptoms of gas frequently caused by air swallowing or certain formulas or foods



Warnings

When using this product do not exceed 12 doses per day

Directions
  • shake well before using
  • all dosages may be repeated as needed, after meals and at bedtime 
  • fill enclosed dropper to recommended dosage level
  • dispense liquid slowly into baby's mouth, toward the inner cheek
  • may mix with 1 oz. of cool water, infant formula or other suitable liquids
  • clean dropper after each use and close the bottle to maintain child resistance


 age (yr) weight (lb) dose
 infants under 2  under 24 0.3 mL
 children over 2 over 24 0.6 mL
Other Information

store at room temperature

Principal Display Panel

Topcare health

COMPARE TO MYLICON® NON-STAINING INFANTS' DROPS ACTIVE INGREDIENT*

NDC 36800-119-09

NON-STAINING

DYE-FREE



infants'

Gas Relief

Drops



SIMETHICONE 20 mg 

ANTI-GAS



  • Gently Breaks Down Baby's Gas Bubbles
  • Safe Enough to Use at Every Feeding**

**use as directed

1 FL OZ (30 mL)



Inactive Ingredients Section

benzoic acid, flavor, magnesium aluminum silicate, purified water, simethicone emulsion, sorbitol, xanthan gum

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

Use(s) (USE(S))

relieves the symptoms of gas frequently caused by air swallowing or certain formulas or foods



Purpose (PURPOSE)

Antigas

Warnings (WARNINGS)

When using this product do not exceed 12 doses per day

Directions (DIRECTIONS)
  • shake well before using
  • all dosages may be repeated as needed, after meals and at bedtime 
  • fill enclosed dropper to recommended dosage level
  • dispense liquid slowly into baby's mouth, toward the inner cheek
  • may mix with 1 oz. of cool water, infant formula or other suitable liquids
  • clean dropper after each use and close the bottle to maintain child resistance


 age (yr) weight (lb) dose
 infants under 2  under 24 0.3 mL
 children over 2 over 24 0.6 mL
Other Information (OTHER INFORMATION)

store at room temperature

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

Topcare health

COMPARE TO MYLICON® NON-STAINING INFANTS' DROPS ACTIVE INGREDIENT*

NDC 36800-119-09

NON-STAINING

DYE-FREE



infants'

Gas Relief

Drops



SIMETHICONE 20 mg 

ANTI-GAS



  • Gently Breaks Down Baby's Gas Bubbles
  • Safe Enough to Use at Every Feeding**

**use as directed

1 FL OZ (30 mL)



Inactive Ingredients Section (INACTIVE INGREDIENTS SECTION)

benzoic acid, flavor, magnesium aluminum silicate, purified water, simethicone emulsion, sorbitol, xanthan gum

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: 2026-02-15T12:05:07.542450 · Updated: 2026-03-14T23:06:27.679265