INFANTS GAS RELIEF DROPS - simethicone emulsion 
Strategic Sourcing Services 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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infant's 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 under2under 240.3 mL
children over 2over 240.6 mL

Other information

store at room temperature

Inactive ingredients

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

Principal Display Panel

NDC 62011-0187-1

Compare to Mylicon® Non-Staining Infants' Drops Active Ingredient*

DYE FREE FORMULA

Infants' Gas Relief Drops

Simethicone 20 mg

Anti-gas

Soothing Relief For Pressure, Bloating & Gas Symptoms

1 fl oz (30 mL)

image description

INFANTS GAS RELIEF DROPS  
simethicone emulsion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62011-0187
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:62011-0187-11 in 1 CARTON10/21/2019
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 finalpart33210/21/2019
Labeler - Strategic Sourcing Services LLC (116956644)

Revised: 1/2022
Document Id: f17b1bb2-3b3b-471c-9496-c4853c2b5257
Set id: fc6887a8-994e-4b2b-ab67-622d1c1f03dd
Version: 5
Effective Time: 20220111
 
Strategic Sourcing Services LLC