INFANTS GAS RELIEF DROPS- simethicone emulsion 
WinCo Foods, LLC

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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Infants Gas Relief Drops

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.

Directions


age (yr)
weight (lb)
dose
infants under2
under 24
0.3 mL
children over 2
over 24
0.6 mL

Other information

store at room temperature

Inactive ingredients

benzoic acid, flavor, magnesium aluminum silicate, purified water, simethicone emulsion, sorbitol, xanthan gum

Questions?

1-800-824-1706 Monday - Friday 9am-4pm MST.

You may also report side effects to this phone number

Principal Display Panel

*Compare to the active ingredient in MYLICON® Non-Staining Infants Drops

Infants Gas Relief Drops

SIMETHICONE 20 mg / ANTI-GAS

Soothing Relief for: Pressure, Bloating & Gas Symptoms

Alcohol Free

Dye Free

1 FL OZ (30 mL)

image description

INFANTS GAS RELIEF DROPS 
simethicone emulsion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:67091-218
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
SORBITOL (UNII: 506T60A25R)  
XANTHAN GUM (UNII: TTV12P4NEE)  
BENZOIC ACID (UNII: 8SKN0B0MIM)  
MAGNESIUM ALUMINUM SILICATE (UNII: 6M3P64V0NC)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:67091-218-301 in 1 CARTON11/24/2014
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 finalpart33211/24/2014
Labeler - WinCo Foods, LLC (056098817)

Revised: 12/2019
Document Id: dc4a7fea-f54a-4897-980c-ad99b1e98880
Set id: f16bbfe0-317d-4c75-b4e2-109957a9c56f
Version: 2
Effective Time: 20191209
 
WinCo Foods, LLC