Infants Gas Relief

Manufacturer: Walgreens | davAgen Pharmaceutical, LLC
Effective date: 2013-12-03
Label type: HUMAN OTC DRUG LABEL
Version: 1
Source: full-release
Hydrated at: 2026-05-31 22:37:53

Label at a glance#

ProductInfants Gas Relief Non-Staining Formula

Active ingredientDimethicone

Label structure11 sections

Indications and uses

Relieves the discomfort of infant gas frequently caused by air swallowing or certain formulas or foods.

Dosage and administration

shake well before using all doses may be repeated as needed, after meals and at bedtime or as directed by a physician. Do not exceed 12 doses per day only use the enclosed syringe. Do not use any other syringe, dropper, spoon or dosing device when giving this medicine to your child. remove cap and insert syringe into hole at top of bottle and turn upside down. Pull back plunger of syringe until syringe filled slig...

Storage and handling

do not use if the neck wrap imprinted with "Safety Seal" is broken or missing store at room temperature do not freeze see bottom panel for lot number and expiration date

Contacts and useful links#

PhonePoison Help1-800-222-1222

PhoneLabel contact1-800-925-4733

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient (in each 0.3 mL)

OTC - ACTIVE INGREDIENT SECTION

Simethicone 20 mg

Purpose

OTC - PURPOSE SECTION

Anti-gas

Uses

INDICATIONS & USAGE SECTION

Relieves the discomfort of infant gas frequently caused by air swallowing or certain formulas or foods.

Warnings

WARNINGS SECTION

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. In case of overdose get medical help or contact a Poison Control Center right away.

(1-800-222-1222)

Directions

DOSAGE & ADMINISTRATION SECTION

shake well before using
all doses may be repeated as needed, after meals and at bedtime or as directed by a physician. Do not exceed 12 doses per day
only use the enclosed syringe. Do not use any other syringe, dropper, spoon or dosing device when giving this medicine to your child.
remove cap and insert syringe into hole at top of bottle and turn upside down. Pull back plunger of syringe until syringe filled slightly over prescribed level. Turn to original position, simply push plunger back until you have reached the prescribe level. Pull syringe out of the bottle and dispense liquid slowly into baby's mouth, toward the inner cheek.
dosage can be mixed with 1 oz. of cool water, infant formula or other suitable liquids
for best results, clean syringe after each use and 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

STORAGE AND HANDLING SECTION

do not use if the neck wrap imprinted with "Safety Seal" is broken or missing
store at room temperature
- do not freeze
see bottom panel for lot number and expiration date

Inactive ingredients

INACTIVE INGREDIENT SECTION

Carbomer 934-P, Citric Acid, Hydroxypropyl Methylcellulose, Natural Flavors, Purified Water, Sodium Benzoate, Sodium Citrate, Sucralose

Questions or comments?

OTC - QUESTIONS SECTION

1-800-Walgreens (1-800-925-4733)

SPL UNCLASSIFIED SECTION

DISTRIBUTED BY:
WALGREEN CO.
200 WILMOT ROAD
DEERFIELD, IL 60015

PRINCIPAL DISPLAY PANEL - 30 mL Bottle Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Well at
Walgreens

WALGREENS PHARMACIST RECOMMENDED^‡

Infants'

Gas Relief

Simethicone 20 mg/Dose
Anti-Gas

Nonstaining formula
No alcohol
No saccharin
No artificial flavor
New dosing syringe design

100 DOSES

Compare to Infants' Mylicon^®
Drops active ingredient^‡‡

1 FL OZ (30 mL)

Principal Display Panel - 30 mL Bottle Carton

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
198857	simethicone 20 MG in 0.3 mL Oral Suspension	PSN	1
198857	simethicone 66.7 MG/ML Oral Suspension	SCD	1
198857	simethicone 20 MG per 0.3 ML Oral Suspension	SY	1
198857	simethicone 40 MG per 0.6 ML Oral Suspension	SY	1

DailyMed Pharmacologic Classes#

Class, Version, Type table
Class	Version	Type	Effective
DIMETHICONE Pharmacologic Class Indexing	3	Indexing - Pharmacologic Class	20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
d5e51f11-ad28-caa4-4b49-4143974782ad	Product name	1	20150831

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
0363-5345-01	2019-11-27	C162847	48780-1	9855e2a2-3ea9-60a7-e053-dbdaa90a05bd	Infant's Gas Relief Non-Staining Formula

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
0363-5345-01	Infants Gas Relief Non-Staining Formula	30 mL in 1 BOTTLE, DROPPER	LIQUID	30		1
0363-5345-01	Infants Gas Relief Non-Staining Formula	1 in 1 CARTON	LIQUID	1		1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0363-5345	INFANTS GAS RELIEF NON-STAINING FORMULA (DIMETHICONE) LIQUID [WALGREENS]	1	Legacy NDC, 2 package rows	20131224_7b44851a-9fe4-4e5d-922b-89fe84d301ca.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
Dimethicone	ACTIVE INGREDIENT	92RU3N3Y1O	1
Dimethicone	ACTIVE MOIETY	92RU3N3Y1O	1
Carbomer Homopolymer Type B (Allyl Sucrose Crosslinked)	INACTIVE INGREDIENT	Z135WT9208	1
Citric Acid Monohydrate	INACTIVE INGREDIENT	2968PHW8QP	1
Hypromelloses	INACTIVE INGREDIENT	3NXW29V3WO	1
Sodium Benzoate	INACTIVE INGREDIENT	OJ245FE5EU	1
Sodium Citrate	INACTIVE INGREDIENT	1Q73Q2JULR	1
Sucralose	INACTIVE INGREDIENT	96K6UQ3ZD4	1
Vanillin	INACTIVE INGREDIENT	CHI530446X	1
Water	INACTIVE INGREDIENT	059QF0KO0R	1

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 10 matching rows.

Infants Gas Relief Non-Staining Formula
Dimethicone
Sodium Benzoate
Citric Acid Monohydrate
Hypromelloses
Carbomer Homopolymer Type B (Allyl Sucrose Crosslinked)
Sucralose
Vanillin
Sodium Citrate
Water

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
0363-5345	0363-5345-01

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 9 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
Dimethicone	92RU3N3Y1O	ACTIB
Sodium Benzoate	OJ245FE5EU	IACT
Citric Acid Monohydrate	2968PHW8QP	IACT
Hypromelloses	3NXW29V3WO	IACT
Carbomer Homopolymer Type B (Allyl Sucrose Crosslinked)	Z135WT9208	IACT
Sucralose	96K6UQ3ZD4	IACT
Vanillin	CHI530446X	IACT
Sodium Citrate	1Q73Q2JULR	IACT
Water	059QF0KO0R	IACT

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 4 · 201 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
Sodium Benzoate	SODIUM BENZOATE	OJ245FE5EU	ELIXIR / ORAL	5.02 mg/5ml		Exact identifier — unii candidate 35 equally ranked IID candidates
Citric Acid Monohydrate	CITRIC ACID MONOHYDRATE	2968PHW8QP	SOLUTION / OPHTHALMIC	0.03 %w/v		Exact identifier — unii candidate 88 equally ranked IID candidates
Sodium Benzoate	SODIUM BENZOATE	OJ245FE5EU	CAPSULE / ORAL	8.5 mg		Exact identifier — unii candidate 35 equally ranked IID candidates
Citric Acid Monohydrate	CITRIC ACID MONOHYDRATE	2968PHW8QP	SOAP / TOPICAL	0.5 %w/w		Exact identifier — unii candidate 88 equally ranked IID candidates
Citric Acid Monohydrate	CITRIC ACID MONOHYDRATE	2968PHW8QP	AEROSOL, FOAM / TOPICAL		1 mg	Exact identifier — unii candidate 88 equally ranked IID candidates
Hypromelloses	HYPROMELLOSE	3NXW29V3WO	CAPSULE, COATED, EXTENDED RELEASE / ORAL	NA		Exact identifier — unii candidate 27 equally ranked IID candidates
Hypromelloses	HYPROMELLOSE	3NXW29V3WO	SUSPENSION / ORAL		305 mg	Exact identifier — unii candidate 27 equally ranked IID candidates
Citric Acid Monohydrate	CITRIC ACID MONOHYDRATE	2968PHW8QP	SHAMPOO, SUSPENSION / TOPICAL	0.25 %w/v		Exact identifier — unii candidate 88 equally ranked IID candidates
Citric Acid Monohydrate	CITRIC ACID MONOHYDRATE	2968PHW8QP	DOUCHE / VAGINAL	0.07 %w/w		Exact identifier — unii candidate 88 equally ranked IID candidates
Vanillin	VANILLIN	CHI530446X	TABLET / ORAL		12 mg	Exact identifier — unii candidate 15 equally ranked IID candidates
Citric Acid Monohydrate	CITRIC ACID MONOHYDRATE	2968PHW8QP	INJECTION, SOLUTION / INTRA-ARTICULAR	ADJ PH		Exact identifier — unii candidate 88 equally ranked IID candidates
Citric Acid Monohydrate	CITRIC ACID MONOHYDRATE	2968PHW8QP	SOLUTION / TOPICAL		17 mg	Exact identifier — unii candidate 88 equally ranked IID candidates
Citric Acid Monohydrate	CITRIC ACID MONOHYDRATE	2968PHW8QP	TABLET, ORALLY DISINTEGRATING / ORAL		83 mg	Exact identifier — unii candidate 88 equally ranked IID candidates
Citric Acid Monohydrate	CITRIC ACID MONOHYDRATE	2968PHW8QP	CAPSULE / ORAL		238 mg	Exact identifier — unii candidate 88 equally ranked IID candidates
Citric Acid Monohydrate	CITRIC ACID MONOHYDRATE	2968PHW8QP	SYSTEM / IONTOPHORESIS	0.2 mg		Exact identifier — unii candidate 88 equally ranked IID candidates
Citric Acid Monohydrate	CITRIC ACID MONOHYDRATE	2968PHW8QP	TABLET, COATED / ORAL	NA		Exact identifier — unii candidate 88 equally ranked IID candidates
Vanillin	VANILLIN	CHI530446X	ELIXIR / ORAL	NA		Exact identifier — unii candidate 15 equally ranked IID candidates
Sucralose	SUCRALOSE	96K6UQ3ZD4	TABLET, ORALLY DISINTEGRATING / ORAL		60 mg	Exact identifier — unii candidate 22 equally ranked IID candidates
Citric Acid Monohydrate	CITRIC ACID MONOHYDRATE	2968PHW8QP	INJECTION, SOLUTION / INTRAVENOUS		396 mg	Exact identifier — unii candidate 88 equally ranked IID candidates
Sodium Benzoate	SODIUM BENZOATE	OJ245FE5EU	TABLET, EXTENDED RELEASE / ORAL	NA		Exact identifier — unii candidate 35 equally ranked IID candidates
Hypromelloses	HYPROMELLOSE	3NXW29V3WO	TABLET / ORAL		1127 mg	Exact identifier — unii candidate 27 equally ranked IID candidates
Sucralose	SUCRALOSE	96K6UQ3ZD4	TABLET, FOR SUSPENSION / ORAL		65 mg	Exact identifier — unii candidate 22 equally ranked IID candidates
Sodium Benzoate	SODIUM BENZOATE	OJ245FE5EU	TABLET, DELAYED RELEASE / ORAL	0.34 mg		Exact identifier — unii candidate 35 equally ranked IID candidates
Sodium Benzoate	SODIUM BENZOATE	OJ245FE5EU	GRANULE / ORAL	NA		Exact identifier — unii candidate 35 equally ranked IID candidates
Citric Acid Monohydrate	CITRIC ACID MONOHYDRATE	2968PHW8QP	POWDER, FOR SUSPENSION / ORAL		840 mg	Exact identifier — unii candidate 88 equally ranked IID candidates
Hypromelloses	HYPROMELLOSE	3NXW29V3WO	TABLET, ORALLY DISINTEGRATING / ORAL		41 mg	Exact identifier — unii candidate 27 equally ranked IID candidates
Carbomer Homopolymer Type B (Allyl Sucrose Crosslinked)	CARBOMER HOMOPOLYMER TYPE B (ALLYL SUCROSE CROSSLINKED)	Z135WT9208	EMULSION / TOPICAL		3405 mg	Exact identifier — unii candidate 14 equally ranked IID candidates
Vanillin	VANILLIN	CHI530446X	LIQUID / ORAL	NA		Exact identifier — unii candidate 15 equally ranked IID candidates
Citric Acid Monohydrate	CITRIC ACID MONOHYDRATE	2968PHW8QP	SUSPENSION / OPHTHALMIC	ADJ PH		Exact identifier — unii candidate 88 equally ranked IID candidates
Citric Acid Monohydrate	CITRIC ACID MONOHYDRATE	2968PHW8QP	INJECTION / INTRACARDIAC	1.05 %w/v		Exact identifier — unii candidate 88 equally ranked IID candidates
Carbomer Homopolymer Type B (Allyl Sucrose Crosslinked)	CARBOMER HOMOPOLYMER TYPE B (ALLYL SUCROSE CROSSLINKED)	Z135WT9208	LOTION / TOPICAL	0.5 %w/w		Exact identifier — unii candidate 14 equally ranked IID candidates
Sodium Benzoate	SODIUM BENZOATE	OJ245FE5EU	PASTE / DENTAL	0.08 %w/w		Exact identifier — unii candidate 35 equally ranked IID candidates
Citric Acid Monohydrate	CITRIC ACID MONOHYDRATE	2968PHW8QP	INJECTION / PERIDURAL	NA		Exact identifier — unii candidate 88 equally ranked IID candidates
Hypromelloses	HYPROMELLOSE	3NXW29V3WO	CAPSULE, DELAYED RELEASE / ORAL		105 mg	Exact identifier — unii candidate 27 equally ranked IID candidates
Hypromelloses	HYPROMELLOSE	3NXW29V3WO	TABLET, FILM COATED / ORAL		582 mg	Exact identifier — unii candidate 27 equally ranked IID candidates
Hypromelloses	HYPROMELLOSE	3NXW29V3WO	SYSTEM / TOPICAL		54 mg	Exact identifier — unii candidate 27 equally ranked IID candidates
Carbomer Homopolymer Type B (Allyl Sucrose Crosslinked)	CARBOMER HOMOPOLYMER TYPE B (ALLYL SUCROSE CROSSLINKED)	Z135WT9208	ENEMA / RECTAL	0.24 %w/v		Exact identifier — unii candidate 14 equally ranked IID candidates
Sodium Benzoate	SODIUM BENZOATE	OJ245FE5EU	FILM, SOLUBLE / BUCCAL		3 mg	Exact identifier — unii candidate 35 equally ranked IID candidates
Sucralose	SUCRALOSE	96K6UQ3ZD4	SPRAY / NASAL		2 mg	Exact identifier — unii candidate 22 equally ranked IID candidates
Sodium Benzoate	SODIUM BENZOATE	OJ245FE5EU	PASTE, DENTIFRICE / DENTAL	0.5 %w/w		Exact identifier — unii candidate 35 equally ranked IID candidates
Sodium Benzoate	SODIUM BENZOATE	OJ245FE5EU	SYSTEM / TOPICAL		2 mg	Exact identifier — unii candidate 35 equally ranked IID candidates
Citric Acid Monohydrate	CITRIC ACID MONOHYDRATE	2968PHW8QP	INJECTION, SOLUTION / INTRAMUSCULAR		26 mg	Exact identifier — unii candidate 88 equally ranked IID candidates
Citric Acid Monohydrate	CITRIC ACID MONOHYDRATE	2968PHW8QP	SOLUTION / INTRAVENOUS		10 mg	Exact identifier — unii candidate 88 equally ranked IID candidates
Citric Acid Monohydrate	CITRIC ACID MONOHYDRATE	2968PHW8QP	LIQUID / RESPIRATORY (INHALATION)	0.13 %w/w		Exact identifier — unii candidate 88 equally ranked IID candidates
Sucralose	SUCRALOSE	96K6UQ3ZD4	TABLET / SUBLINGUAL		12 mg	Exact identifier — unii candidate 22 equally ranked IID candidates
Sucralose	SUCRALOSE	96K6UQ3ZD4	FILM / ORAL		1 mg	Exact identifier — unii candidate 22 equally ranked IID candidates
Vanillin	VANILLIN	CHI530446X	TABLET, ORALLY DISINTEGRATING / ORAL	0.26 mg		Exact identifier — unii candidate 15 equally ranked IID candidates
Sodium Benzoate	SODIUM BENZOATE	OJ245FE5EU	TABLET, COATED / ORAL	0.2 mg		Exact identifier — unii candidate 35 equally ranked IID candidates
Hypromelloses	HYPROMELLOSE	3NXW29V3WO	CAPSULE, EXTENDED RELEASE / ORAL	119.7 mg		Exact identifier — unii candidate 27 equally ranked IID candidates
Hypromelloses	HYPROMELLOSE	3NXW29V3WO	SUSPENSION / OPHTHALMIC	0.5 %w/w		Exact identifier — unii candidate 27 equally ranked IID candidates
Hypromelloses	HYPROMELLOSE	3NXW29V3WO	SHAMPOO / TOPICAL	3 %w/w		Exact identifier — unii candidate 27 equally ranked IID candidates
Citric Acid Monohydrate	CITRIC ACID MONOHYDRATE	2968PHW8QP	TABLET, CHEWABLE / ORAL	7 mg		Exact identifier — unii candidate 88 equally ranked IID candidates
Citric Acid Monohydrate	CITRIC ACID MONOHYDRATE	2968PHW8QP	LIQUID / ORAL		114 mg	Exact identifier — unii candidate 88 equally ranked IID candidates
Carbomer Homopolymer Type B (Allyl Sucrose Crosslinked)	CARBOMER HOMOPOLYMER TYPE B (ALLYL SUCROSE CROSSLINKED)	Z135WT9208	GEL, METERED / TRANSDERMAL	1 %w/w		Exact identifier — unii candidate 14 equally ranked IID candidates
Citric Acid Monohydrate	CITRIC ACID MONOHYDRATE	2968PHW8QP	SOLUTION / BUCCAL	NA		Exact identifier — unii candidate 88 equally ranked IID candidates
Hypromelloses	HYPROMELLOSE	3NXW29V3WO	TABLET, COATED / ORAL		58 mg	Exact identifier — unii candidate 27 equally ranked IID candidates
Carbomer Homopolymer Type B (Allyl Sucrose Crosslinked)	CARBOMER HOMOPOLYMER TYPE B (ALLYL SUCROSE CROSSLINKED)	Z135WT9208	CREAM / TOPICAL		600 mg	Exact identifier — unii candidate 14 equally ranked IID candidates
Sodium Benzoate	SODIUM BENZOATE	OJ245FE5EU	GEL / TOPICAL		5 mg	Exact identifier — unii candidate 35 equally ranked IID candidates
Citric Acid Monohydrate	CITRIC ACID MONOHYDRATE	2968PHW8QP	INJECTION / INTRAMUSCULAR		28 mg	Exact identifier — unii candidate 88 equally ranked IID candidates
Citric Acid Monohydrate	CITRIC ACID MONOHYDRATE	2968PHW8QP	TABLET, EXTENDED RELEASE / ORAL		45 mg	Exact identifier — unii candidate 88 equally ranked IID candidates

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
5a8606c8-c137-40a8-b3d8-87a70c44f2fa			7b44851a-9fe4-4e5d-922b-89fe84d301ca	2013-12-03	Warnings	Exact identifier spl id: 5a8606c8-c137-40a8-b3d8-87a70c44f2fa spl set id: 7b44851a-9fe4-4e5d-922b-89fe84d301ca

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.