GOOD SENSE SIMETHICONE INFANTS- simethicone emulsion 
L. Perrigo Company

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Perrigo Infants' Simethicone Drops Drug Facts

Active ingredient (in each 0.3 mL)

Simethicone 20 mg

Purpose

Antigas

Uses

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

Warnings

When using this product

do not exceed 12 doses per day

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

shake well before using
find right dose on chart below. If possible, use weight to dose; otherwise, use age.
only use the enclosed syringe. Do not use other syringe, dropper, spoon or dosing device when giving this medicine to your child.
remove cap and insert syringe into the bottle
pull syringe up until filled to the prescribed level. If you pass the prescribed level, simply push syringe back until you have reached the desired level. Slowly dispense the liquid into your child’s mouth (towards inner cheek).
all dosages may be repeated as needed, after meals and at bedtime or as directed by a physician
do not exceed 12 doses per day
dosage can also be mixed with 1 oz. cool water, infant formula or other suitable liquids
replace cap tightly to maintain child resistance
mL = milliliter

Age (yr)

Weight (lb)

Dose (mL)

infants under 2

under 24

0.3

children over 2

over 24

0.6

Other information

do not use if printed bottle wrap is broken or missing
store at 20-25°C (68-77°F)
do not freeze

Inactive ingredients

anhydrous citric acid, flavor, hypromellose, maltitol solution, purified water, simethicone emulsion, sodium benzoate, sodium citrate, xanthan gum

Questions or comments?

1-800-719-9260

Principal Display Panel

Gas Relief

Pediatrician Recommended #1 Active Ingredient

Infants’ Simethicone Drops

Simethicone 20 mg

Anti-Gas

Gently Breaks Down Baby’s Gas Bubbles

Safe Enough to Use at Every Feeding**

Non-Staining

Dye Free Drops

Compare to active ingredient of Infants’ Mylicon® Drops

100% SATISFACTION GUARANTEED

1 FL OZ (30 mL)

**Use as Directed

infants simethicone drops image
GOOD SENSE SIMETHICONE  INFANTS
simethicone emulsion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0113-0882
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE20 mg  in 0.3 mL
Inactive Ingredients
Ingredient NameStrength
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
WATER (UNII: 059QF0KO0R)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)  
XANTHAN GUM (UNII: TTV12P4NEE)  
Product Characteristics
ColorWHITE (white to off white, opaque) Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0113-0882-101 in 1 CARTON02/23/200011/30/2021
130 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart33202/23/200011/30/2021
Labeler - L. Perrigo Company (006013346)

Revised: 9/2022
 
L. Perrigo Company