EXTRA 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.

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722T_Kroger_41226-722_Simethicone softgel 125mg

Drug Facts

Active ingredient

Active ingredient (in each softgel)

Simethicone 125 mg

Purpose

Purpose

Anti-gas

Use

Use for the relief of

Warning

Warning

Keep out of reach of children.

Directions

Directions

Other information

Other information

Inactive ingredients

Inactive ingredients

D&C Yellow 10, FD&C Red #40, FD&C Blue 1, gelatin, glycerol, medium chain triglyceride, peppermint oil, propylene glycol, purified water, shellac, sorbitol sorbitan solution, titanium dioxide

Questions or comments?

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

722T_Kroger_Simethicone capsules 125mg

EXTRA STRENGTH GAS RELIEF 
simethicone capsule
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:41226-722
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE125 mg
Inactive Ingredients
Ingredient NameStrength
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
PEPPERMINT OIL (UNII: AV092KU4JH)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
SHELLAC (UNII: 46N107B71O)  
SORBITOL SOLUTION (UNII: 8KW3E207O2)  
GLYCERIN (UNII: PDC6A3C0OX)  
WATER (UNII: 059QF0KO0R)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
GELATIN (UNII: 2G86QN327L)  
Product Characteristics
ColorgreenScoreno score
ShapeOVALSize10mm
FlavorImprint Code 105
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:41226-722-302 in 1 CARTON05/05/2023
115 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart33205/05/2023
Labeler - KROGER COMPANY (006999528)
Registrant - TIME CAP LABORATORIES, INC. (037052099)
Establishment
NameAddressID/FEIBusiness Operations
MARKSANS PHARMA LIMITED925822975manufacture(41226-722)

Revised: 5/2023
Document Id: fab0c1b9-96a4-df9c-e053-6294a90a8e28
Set id: ea1c7b4c-91a1-0c1c-e053-2995a90ab823
Version: 2
Effective Time: 20230505
 
KROGER COMPANY