SIMETHICONE INFANT GAS RELIEF DROPS fast instant gas relief

Manufacturer: AARNA USA Inc. | KJD PHARMA PRIVATE LIMITED
Effective date: 2025-07-29
Label type: HUMAN OTC DRUG LABEL
Version: 3
Source: full-release
Hydrated at: 2026-06-01 01:08:53

Label at a glance#

ProductSIMETHICONE INFANT Gas Relief Drops

Active ingredientDIMETHICONE

Label structure8 sections

Indications and uses

relieves the symptoms referred to as gas

Dosage and administration

shake well before using all dosages may be repeated as needed, alter meals and at bedtime, or as directed by a physician do not exceed 12 doses per day fill enclosed dropper to recommended dosage level and dispense liquid slowly into baby's mouth, toward the inner cheek dosage can also be mixed with 1 oz. of cool water, infant formula or other suitable liquids Age (years) Weight (lbs) Dose infants (under 2) under ...

Storage and handling

TAMPER-EVIDENT : Do not use if printed seal under cap is broken or punctured store at room temperature do not freeze see bottom panel for lot number and expiration date

Contacts and useful links#

PhoneLabel contact1-877-225-6999

Label contents#

Full prescribing information#

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 referred to as gas

Warnings

WARNINGS SECTION

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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Directions

DOSAGE & ADMINISTRATION SECTION

shake well before using
all dosages may be repeated as needed, alter meals and at bedtime, or as directed by a physician
do not exceed 12 doses per day
fill enclosed dropper to recommended dosage level and dispense liquid slowly into baby's mouth, toward the inner cheek
dosage can also be mixed with 1 oz. of cool water, infant formula or other suitable liquids

Age (years)	Weight (lbs)	Dose
infants (under 2)	under 24	0.3 mL
children (2 and over)	24 and over	0.6 mL

Other information

STORAGE AND HANDLING SECTION

TAMPER-EVIDENT:Do not use if printed seal under cap is broken or punctured
store at room temperature
do not freeze
see bottom panel for lot number and expiration date

Inactive ingredients

INACTIVE INGREDIENT SECTION

Carboxymethylcellulose sodium, Citric acid, Flavor strawberry, Microcrystalline cellulose, Polysorbate 60, Potassium sorbate, Purified water, Sodium benzoate, Sorbitan monostearate, Sorbitol solution, Xanthan gum.

Questions or comments ?

OTC - QUESTIONS SECTION

Call toll-free 1-877-225-6999.

Manufactured for:

AARNA USA Inc.

Leland, NC-28451

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

123

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	3
198857	simethicone 66.7 MG/ML Oral Suspension	SCD	3
198857	simethicone 20 MG per 0.3 ML Oral Suspension	SY	3
198857	simethicone 40 MG per 0.6 ML Oral Suspension	SY	3

DailyMed Pharmacologic Classes#

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
82568-0017-3	SIMETHICONE INFANTGas Relief Drops	1 in 1 PACKAGE	SUSPENSION	1	3
82568-0017-3	SIMETHICONE INFANTGas Relief Drops	30 mL in 1 BOTTLE	SUSPENSION	30	3
82568-0017-4	SIMETHICONE INFANTGas Relief Drops	118 mL in 1 BOTTLE	SUSPENSION	118	3

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
82568-0017-3	ML - Milliliter	82568-0017	b5bb14da-65f2-41ba-89f9-e1555f0e1b56	1	2025-10-14
82568-0017-4	ML - Milliliter	82568-0017	c1386582-32de-40f1-8f29-0a70ca9eb35e	1	2025-11-13

Products#

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

DailyMed product names page 1 of 1 · 13 matching rows.

SIMETHICONE INFANT Gas Relief Drops
Simethicone
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM
ANHYDROUS CITRIC ACID
MICROCRYSTALLINE CELLULOSE
POLYSORBATE 60
POTASSIUM SORBATE
WATER
SODIUM BENZOATE
SORBITAN MONOSTEARATE
SORBITOL
XANTHAN GUM
DIMETHICONE

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
82568-0017	82568-0017-4, 82568-0017-3

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 11 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM	K679OBS311	IACT
ANHYDROUS CITRIC ACID	XF417D3PSL	IACT
MICROCRYSTALLINE CELLULOSE	OP1R32D61U	IACT
POLYSORBATE 60	CAL22UVI4M	IACT
POTASSIUM SORBATE	1VPU26JZZ4	IACT
WATER	059QF0KO0R	IACT
SODIUM BENZOATE	OJ245FE5EU	IACT
SORBITAN MONOSTEARATE	NVZ4I0H58X	IACT
SORBITOL	506T60A25R	IACT
XANTHAN GUM	TTV12P4NEE	IACT
DIMETHICONE	92RU3N3Y1O	ACTIB

Source Document#

Source XML

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
SIMETHICONE INFANT Gas Relief Drops	SIMETHICONE	AARNA USA Inc.	9b0fde90-35ae-498e-99cc-d120f1a87182	2025-07-29	Warnings	Exact identifier ndc (package): 82568-0017-3 ndc (package): 82568-0017-4 ndc (product): 82568-0017 ndc11 (package): 82568001703 ndc11 (package): 82568001704 spl id: 3b14f103-c7f9-f905-e063-6294a90a0e2c spl set id: 9b0fde90-35ae-498e-99cc-d120f1a87182

Reported adverse events (FAERS/openFDA)#

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