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Infants Gas Relief by Shopko Stores Operating Co., LLC

Medically reviewed on Apr 9, 2018

Dosage form: emulsion
Ingredients: SIMETHICONE 20mg in 0.3mL
Labeler: Shopko Stores Operating Co., LLC
NDC Code: 37012-882

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.

Shopko Infants’ Gas Relief 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
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.
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. cool water, infant formula or other suitable liquids
clean dropper well after each use – recap bottle with 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
store at 20-25°C (68-77°F)
do not use if printed bottle wrap is broken or missing

Inactive ingredients

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

Questions?

1-800-719-9260

Principal Display Panel

Compare to Infants’ Mylicon® Drops active ingredient

Infants’

Gas Relief Drops

Simethicone 20 mg/Anti-gas

Safe for Every Feeding

Dye-Free

Non-Staining

No Artificial Colors

No Artificial Flavor

No Alcohol

No Saccharin

1 FL OZ (30 mL)

INFANTS GAS RELIEF 
simethicone emulsion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:37012-882
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SIMETHICONE (SIMETHICONE) SIMETHICONE20 mg  in 0.3 mL
Inactive Ingredients
Ingredient NameStrength
SILICON DIOXIDE 
ANHYDROUS CITRIC ACID 
HYPROMELLOSES 
WATER 
SODIUM BENZOATE 
SODIUM CITRATE 
XANTHAN GUM 
Product Characteristics
ColorWHITE (white to off white, opaque) Score    
ShapeSize
FlavorSTRAWBERRYImprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:37012-882-101 BOTTLE in 1 CARTON
130 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart33211/27/2013
Labeler - Shopko Stores Operating Co., LLC (023252638)

 
Shopko Stores Operating Co., LLC

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Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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