ULTRA STRENGTH GAS RELIEF- simethicone capsule 
KROGER COMPANY

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.

----------

717T Kroger 41226-717 Simethicone capsules 180 mg

Drug Facts

Active ingredient (in each softgel)
Simethicone 180 mg

Purpose
Anti-gas

Uses
• Relieves bloating, pressure or fullness commonly referred to as gas.

Warnings

Stop use and ask a doctor if condition persists.

Keep out of reach of children.

Directions
• Swallow one or two softgels as symptoms occur.
• Do not exceed two softgels per 24 hours except under the advice and supervision of a physician.

Other information
• Store at room temperature

Inactive ingredients
FD&C Yellow No. 6, gelatin, glycerol, medium chain triglyceride, peppermint oil, propylene glycol, purified water, shellac, sorbitol sorbitan solution, titanium dioxide

Questions or comments? Call 1-800-632-6900

717T-KR-Simethicone-30s-label717T-KR-Simethicone-30s-ifc

ULTRA STRENGTH GAS RELIEF 
simethicone capsule
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:41226-717
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE180 mg
Inactive Ingredients
Ingredient NameStrength
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
SORBITOL SOLUTION (UNII: 8KW3E207O2)  
GELATIN (UNII: 2G86QN327L)  
GLYCERIN (UNII: PDC6A3C0OX)  
PEPPERMINT OIL (UNII: AV092KU4JH)  
SHELLAC (UNII: 46N107B71O)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
WATER (UNII: 059QF0KO0R)  
Product Characteristics
Colororange (Orange Translucent) Scoreno score
ShapeOVALSize11mm
FlavorImprint Code 104
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:41226-717-301 in 1 CARTON05/05/2023
160 in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalM00205/05/2023
Labeler - KROGER COMPANY (006999528)
Registrant - TIME CAP LABORATORIES, INC. (037052099)
Establishment
NameAddressID/FEIBusiness Operations
MARKSANS PHARMA LIMITED925822975manufacture(41226-717)

Revised: 5/2023
Document Id: fa789d40-7a48-186d-e053-6394a90a449c
Set id: ea1c4aa8-bde6-2072-e053-2995a90a93ba
Version: 2
Effective Time: 20230505
 
KROGER COMPANY