INFANTS GAS RELIEF- simethicone solution/ drops 
Topco Associates, 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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Topco Infants Gas Relief Drops

ACTIVE INGREDIENT (in each 0.3 mL)

Simethicone 20 mg

PURPOSE

Antigas

USE(S)

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 under 2 under 240.3 mL
 children over 2over 240.6 mL

OTHER INFORMATION

store at room temperature

INACTIVE INGREDIENTS SECTION

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

PRINCIPAL DISPLAY PANEL

Topcare health

COMPARE TO MYLICON® NON-STAINING INFANTS' DROPS ACTIVE INGREDIENT*

NDC 36800-119-09

NON-STAINING

DYE-FREE


infants'

Gas Relief

Drops


SIMETHICONE 20 mg 

ANTI-GAS


**use as directed

1 FL OZ (30 mL)


74

INFANTS GAS RELIEF 
simethicone solution/ drops
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:36800-119
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
BENZOIC ACID (UNII: 8SKN0B0MIM)  
MAGNESIUM ALUMINUM SILICATE (UNII: 6M3P64V0NC)  
WATER (UNII: 059QF0KO0R)  
SORBITOL (UNII: 506T60A25R)  
XANTHAN GUM (UNII: TTV12P4NEE)  
Product Characteristics
ColorWHITE (off-white) Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:36800-119-091 in 1 CARTON03/01/2013
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 FINALpart33203/01/2013
Labeler - Topco Associates, LLC (006935977)
Establishment
NameAddressID/FEIBusiness Operations
Guardian Drug Company119210276MANUFACTURE(36800-119)

Revised: 5/2021
Document Id: fd6a2537-8db2-492d-b045-6404df2fb9c3
Set id: fd6a2537-8db2-492d-b045-6404df2fb9c3
Version: 1
Effective Time: 20210512
 
Topco Associates, LLC