Select Brand Infant's Gas Relief Drops

SPL v1

SPL

SPL Set ID 96612f9b-aa15-4ef5-9ec4-eab44f3c69c7

Route

ORAL

Published

Effective Date 2014-09-05

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 2013-02-02

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

Other Information

store at room temperature

Inactive Ingredients

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

Principal Display Panel

Select Brand

Compare to the active ingredient in Infants Mylicon^® Drops

Infant's Gas Relief Drops

Simethicone

Anti-Gas

Non-staining

Excess Gas relief

Alcohol Free

Saccharin Free

No Artificial Flaovr

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 immediately.

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

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

Select Brand

Compare to the active ingredient in Infants Mylicon^® Drops

Infant's Gas Relief Drops

Simethicone

Anti-Gas

Non-staining

Excess Gas relief

Alcohol Free

Saccharin Free

No Artificial Flaovr

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 immediately.

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", "Other information": "store at room temperature", "Inactive ingredients": "benzoic acid, flavor, magnesium aluminum silicate, purified water, simethicone emulsion, sorbitol, xanthan gum", "Principal Display Panel": "Select Brand Compare to the active ingredient in Infants Mylicon ® Drops Infant's Gas Relief Drops Simethicone Anti-Gas Non-staining Excess Gas relief Alcohol Free Saccharin Free No Artificial Flaovr 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 immediately.", "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: 2026-02-15T11:55:50.481566 · Updated: 2026-03-14T22:53:51.342349