SIMETHICONE INFANT GAS RELIEF DROPS- simethicone suspension

SIMETHICONE INFANT by

Drug Labeling and Warnings

SIMETHICONE INFANT by is a Otc medication manufactured, distributed, or labeled by AARNA USA Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient (in each 0.3 mL)

Simethicone 20 mg

Purpose

Antigas

Uses

relieves the symptoms referred to as gas

Warnings

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

Directions

• 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

• 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

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 ?

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

Manufactured for:

AARNA USA Inc.

Leland, NC-28451

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

SIMETHICONE INFANT   GAS RELIEF DROPS
simethicone suspension

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 82568-0017
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O)	DIMETHICONE	20 mg  in 0.3 mL

Inactive Ingredients
Ingredient Name	Strength
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311)
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
POLYSORBATE 60 (UNII: CAL22UVI4M)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
WATER (UNII: 059QF0KO0R)
SODIUM BENZOATE (UNII: OJ245FE5EU)
SORBITAN MONOSTEARATE (UNII: NVZ4I0H58X)
SORBITOL (UNII: 506T60A25R)
XANTHAN GUM (UNII: TTV12P4NEE)

Product Characteristics
Color		Score
Shape		Size
Flavor	STRAWBERRY	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 82568-0017-4	118 mL in 1 BOTTLE; Type 0: Not a Combination Product	02/20/2025
2	NDC: 82568-0017-3	1 in 1 PACKAGE	02/20/2025
2		30 mL in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M002	02/20/2025

Labeler - AARNA USA Inc. (118515992)

Establishment
Name	Address	ID/FEI	Business Operations
KJD PHARMA PRIVATE LIMITED		877256314	manufacture(82568-0017)