Equaline Infant's Gas Relief Drops

SPL v2

SPL

SPL Set ID a9902ba0-f239-4e66-8d66-7cef39a5fdc3

Route

ORAL

Published

Effective Date 2024-12-20

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 2021-08-26

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

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

Compare to Mylicon^® infant drops active ingredient*

NDC 41163-096-09

EQUALINE

infants'

gas relief

drops

simethicone 20 mg

(anti-gas)

gently breaks down baby's gas bubbles
safe enough to use at every feeding**

DYE-FREE

NON-STAINING

**USE AS DIRECTED

1 FL OZ (30 mL)

When Using This Product

do not exceed 12 doses per day

Keep Out of the 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)

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)

Compare to Mylicon^® infant drops active ingredient*

NDC 41163-096-09

EQUALINE

infants'

gas relief

drops

simethicone 20 mg

(anti-gas)

gently breaks down baby's gas bubbles
safe enough to use at every feeding**

DYE-FREE

NON-STAINING

**USE AS DIRECTED

1 FL OZ (30 mL)

When Using This Product (WHEN USING THIS PRODUCT)

do not exceed 12 doses per day

Keep Out of the Reach of Children (KEEP OUT OF THE 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": "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": "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)

{"USE(S)": "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 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": "Compare to Mylicon ® infant drops active ingredient* NDC 41163-096-09 EQUALINE infants' gas relief drops simethicone 20 mg (anti-gas) gently breaks down baby's gas bubbles safe enough to use at every feeding** DYE-FREE NON-STAINING **USE AS DIRECTED 1 FL OZ (30 mL)", "WHEN USING THIS PRODUCT": "do not exceed 12 doses per day", "KEEP OUT OF THE 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

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Source: dailymed · Ingested: 2026-02-15T12:04:58.678812 · Updated: 2026-03-14T23:06:13.532900