Quality Choice Infants Non-staining Gas Relief 520

Quality Choice Infants Non-staining Gas Relief 520
SPL v2
SPL
SPL Set ID 17e181e5-6527-54d0-e063-6294a90addc2
Route
ORAL
Published
Effective Date 2024-08-22
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 2024-08-21

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

Inactive Ingredients

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

Principal Display Panel

83324-133-01

QC

Quality Choice 

*Compare to the Active Ingredient in Mylicon®

Non-Staining Infants' Drops

Infants' Non-Staining

Gas Relief Drops

Antigas

Simethicone 20 mg

Fast Relief of Gas Symptoms 

No Artificial Flavor 

Alcohol Free

Dye Free

Gentle & Safe**

**Use only as directed;

do not exceed 12 doses per day.

1 FL OZ (30mL)

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

Inactive Ingredients (INACTIVE INGREDIENTS)

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

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

83324-133-01

QC

Quality Choice 

*Compare to the Active Ingredient in Mylicon®

Non-Staining Infants' Drops

Infants' Non-Staining

Gas Relief Drops

Antigas

Simethicone 20 mg

Fast Relief of Gas Symptoms 

No Artificial Flavor 

Alcohol Free

Dye Free

Gentle & Safe**

**Use only as directed;

do not exceed 12 doses per day.

1 FL OZ (30mL)

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

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