Select Brand Infant's Gas Relief Drops

Set ID
96612f9b-aa15-4ef5-9ec4-eab44f3c69c7
Manufacturer
Select Brand
Effective date
2014-09-05
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:40:25

Key Label Information

Active Ingredients And Purpose

Active ingredient (in each 0.3 mL)

simethicone 20 mg

Purpose

Antigas

Uses

Uses

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

Warnings

Warnings

Directions And Dosage

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 Label Information

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)

Products

NDC Codes

Ingredients

NameUNIIKind
DIMETHICONE92RU3N3Y1OACTIB
SORBITOL506T60A25RIACT
XANTHAN GUMTTV12P4NEEIACT
BENZOIC ACID8SKN0B0MIMIACT
MAGNESIUM ALUMINUM SILICATE6M3P64V0NCIACT
WATER059QF0KO0RIACT

Complete SPL Sections

Active ingredient (in each 0.3 mL)

OTC - ACTIVE INGREDIENT SECTION

simethicone 20 mg

Purpose

OTC - PURPOSE SECTION

Antigas

Uses

INDICATIONS & USAGE SECTION

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

Warnings

WARNINGS SECTION

Directions

DOSAGE & ADMINISTRATION SECTION

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

STORAGE AND HANDLING SECTION

store at room temperature

Inactive ingredients

INACTIVE INGREDIENT SECTION

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

Principal Display Panel

PACKAGE LABEL.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)

Source Document

Official SPL XML cached by FDA.report · DailyMed PDF

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XML SHA-256
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XML bytes
15383

Legacy File Index

FolderFileDate
otc0f3c6d9c-2054-42b3-820b-dd2d32e6fe3c.xml2014-10-02
otcSB520B.jpg2014-10-02