Sunmark Gas Relief Drops Infants

SPL v1

SPL

SPL Set ID 8c2d86d8-2e67-41c2-a4ce-5a3904408a02

Route

ORAL

Published

Effective Date 2012-09-10

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 D&c Red No. 22 D&c Red No. 28 Sorbitol Xanthan Gum

Identifiers & Packaging

Pill Appearance

Color: pink

Marketing Status

OTC MONOGRAPH FINAL Active Since 2003-10-31

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

Warnings

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 replace original cap.

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 (59^oF-86^oF)

Inactive Ingredients

benzoic acid, red # 22, red # 28, flavor, magnesium aluminum silicate, purified water, sorbitol, xanthan gum.

Principal Display Panel

Sunmark

compare to Mylicon^® Infant drops active ingredient

gas relief drops infants'

Fast relief of gas symptoms

Alcohol and Saccharin free

No artificial flavor

1 fl oz (30 mL) 100 Doses

When Using This Product

do not exceed 12 doses per day

Active Ingredient (in Each 0.3 Ml)

Simethicone 20 mg

Keep Out of the Reach of Children.

Structured Label Content

Uses

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

Purpose

Antigas

Warnings

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 replace original cap.

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 (59^oF-86^oF)

Inactive Ingredients (Inactive ingredients)

benzoic acid, red # 22, red # 28, flavor, magnesium aluminum silicate, purified water, sorbitol, xanthan gum.

Principal Display Panel

Sunmark

compare to Mylicon^® Infant drops active ingredient

gas relief drops infants'

Fast relief of gas symptoms

Alcohol and Saccharin free

No artificial flavor

1 fl oz (30 mL) 100 Doses

When Using This Product (When using this product)

do not exceed 12 doses per day

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

Simethicone 20 mg

Keep Out of the Reach of Children. (Keep out of the reach of children.)

Advanced Ingredient Data

[{"name": "DIMETHICONE", "unii": "92RU3N3Y1O", "classCode": "ACTIB", "strengthNumerator": "20", "strengthDenominator": "0.3", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "mL"}, {"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": ""}, {"name": "D&C RED NO. 22", "unii": "1678RKX8RT", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "D&C RED NO. 28", "unii": "767IP0Y5NH", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SORBITOL", "unii": "506T60A25R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "XANTHAN GUM", "unii": "TTV12P4NEE", "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 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 replace original cap. 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 (59 o F-86 o F)", "Inactive ingredients": "benzoic acid, red # 22, red # 28, flavor, magnesium aluminum silicate, purified water, sorbitol, xanthan gum.", "Principal Display Panel": "Sunmark compare to Mylicon ® Infant drops active ingredient gas relief drops infants' Fast relief of gas symptoms Alcohol and Saccharin free No artificial flavor 1 fl oz (30 mL) 100 Doses", "When using this product": "do not exceed 12 doses per day", "Active ingredient (in each 0.3 mL)": "Simethicone 20 mg"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:55:31.048832 · Updated: 2026-03-14T22:53:16.318838