TOPCARE GAS RELIEF EXTRA STRENGTH- simethicone capsule, liquid filled 
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.

----------

Topco Associates LLC. Gas Relief Drug Facts

Active ingredient (in each softgel)

Simethicone 125 mg

Purpose

Antigas

Uses

relieves pressure and bloating commonly referred to as gas

Warnings

Keep out of reach of children

Directions

•
do not exceed 4 softgels in 24 hours
•
adults: swallow with water 1 or 2 softgels as needed after meals and at bedtime

Other information

store at 20°-25°C

Inactive ingredients

D&C yellow #10, edible ink, FD&C blue #1, FD&C red #40, gelatin, glycerin, mannitol, peppermint oil, purified water, sorbitan, sorbitol, titanium dioxide

Questions or comments?

1-888-423-0139

Principal Display Panel

Extra Strength

Gas Relief

Softgels

Anti-Gas

Simethicone 125 mg

Relieves Gas Fast

Pressure

Bloating

Discomfort

Actual Size

Compare to Gas-X® Extra Strength Softgels active ingredient

Gas Relief Carton

Gas Relief Carton

Gas Relief Carton

TOPCARE GAS RELIEF  EXTRA STRENGTH
simethicone capsule, liquid filled
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:36800-428
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE125 mg
Inactive Ingredients
Ingredient NameStrength
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
GELATIN (UNII: 2G86QN327L)  
GLYCERIN (UNII: PDC6A3C0OX)  
MANNITOL (UNII: 3OWL53L36A)  
PEPPERMINT OIL (UNII: AV092KU4JH)  
WATER (UNII: 059QF0KO0R)  
SORBITAN (UNII: 6O92ICV9RU)  
SORBITOL (UNII: 506T60A25R)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
Product Characteristics
ColorGREENScoreno score
ShapeOVALSize10mm
FlavorImprint Code L428
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:36800-428-602 in 1 CARTON01/29/200201/20/2012
110 in 1 BLISTER PACK; Type 0: Not a Combination Product
2NDC:36800-428-653 in 1 CARTON01/29/200201/20/2012
210 in 1 BLISTER PACK; Type 0: Not a Combination Product
3NDC:36800-428-715 in 1 CARTON01/29/200201/20/2012
310 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart33201/29/200201/20/2012
Labeler - Topco Associates LLC (006935977)

Revised: 11/2017
Document Id: c9916875-40ad-4965-84f9-4f359ae4d6fe
Set id: e471a42d-3d56-41b1-a7ff-5609eae1559c
Version: 2
Effective Time: 20171110
 
Topco Associates LLC