Infants Gas Relief Drops

SPL v2

SPL

SPL Set ID f16bbfe0-317d-4c75-b4e2-109957a9c56f

Route

ORAL

Published

Effective Date 2019-12-09

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Dimethicone (20 mg)

Inactive Ingredients

Sorbitol Xanthan Gum Benzoic Acid Magnesium Aluminum Silicate Water

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH FINAL Active Since 2014-11-24

Description

simethicone 20 mg

Purpose

Antigas

Medication Information

Purpose

Antigas

Description

simethicone 20 mg

Uses

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

Section 50565-1

Warnings

Directions

shake well before using
all dosages may be repeated as needed, after meals and at bedtime
fill enclosed dropper to recommend 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 under2	under 24	0.3 mL
children over 2	over 24	0.6 mL

Questions?

1-800-824-1706 Monday - Friday 9am-4pm MST.

You may also report side effects to this phone number

Other Information

store at room temperature

Inactive Ingredients

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

Principal Display Panel

*Compare to the active ingredient in MYLICON^®Non-Staining Infants Drops

Infants Gas Relief Drops

SIMETHICONE 20 mg / ANTI-GAS

Soothing Relief for: Pressure, Bloating & Gas Symptoms

Alcohol Free

Dye Free

1 FL OZ (30 mL)

When Using This Product

do not exceed 12 doses per day

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

Section 50565-1 (50565-1)

Purpose

Antigas

Warnings

Directions

shake well before using
all dosages may be repeated as needed, after meals and at bedtime
fill enclosed dropper to recommend 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 under2	under 24	0.3 mL
children over 2	over 24	0.6 mL

Questions?

1-800-824-1706 Monday - Friday 9am-4pm MST.

You may also report side effects to this phone number

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

*Compare to the active ingredient in MYLICON^®Non-Staining Infants Drops

Infants Gas Relief Drops

SIMETHICONE 20 mg / ANTI-GAS

Soothing Relief for: Pressure, Bloating & Gas Symptoms

Alcohol Free

Dye Free

1 FL OZ (30 mL)

When Using This Product (When using this product)

do not exceed 12 doses per day

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

[{"name": "DIMETHICONE", "unii": "92RU3N3Y1O", "classCode": "ACTIB", "strengthNumerator": "20", "strengthDenominator": "0.3", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "mL"}, {"name": "SORBITOL", "unii": "506T60A25R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "XANTHAN GUM", "unii": "TTV12P4NEE", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "BENZOIC ACID", "unii": "8SKN0B0MIM", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "MAGNESIUM ALUMINUM SILICATE", "unii": "6M3P64V0NC", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "WATER", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}]

Raw Label Data

All Sections (JSON)

{"Uses": "relieves the symptoms of gas frequently caused by air swallowing or certain formulas or foods", "Purpose": "Antigas", "Directions": "shake well before using all dosages may be repeated as needed, after meals and at bedtime fill enclosed dropper to recommend 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 under2 under 24 0.3 mL children over 2 over 24 0.6 mL", "Questions?": "1-800-824-1706 Monday - Friday 9am-4pm MST. You may also report side effects to this phone number", "Other information": "store at room temperature", "Inactive ingredients": "benzoic acid, flavor, magnesium aluminum silicate, purified water, simethicone emulsion, sorbitol, xanthan gum", "Principal Display Panel": "*Compare to the active ingredient in MYLICON ® Non-Staining Infants Drops Infants Gas Relief Drops SIMETHICONE 20 mg / ANTI-GAS Soothing Relief for: Pressure, Bloating & Gas Symptoms Alcohol Free Dye Free 1 FL OZ (30 mL)", "When using this product": "do not exceed 12 doses per day 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"}

Additional Information

Back to search View SPL set listing Open on DailyMed ↗

Source: dailymed · Ingested: 2026-02-15T11:56:57.290678 · Updated: 2026-03-14T22:55:46.109144