GAS RELIEF- simethicone capsule, liquid filled 
The Kroger Co.

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.

----------

DRUG FACTS

Active Ingredient (in each softgel)

Simethicone 125 mg

Purpose

Antiflatulent (Antigas)

Use

relieves bloating, pressure, or fullness commonly referred to as gas.

Warnings

Stop use and ask a doctor if

 condition persists

If pregnant or breast- feeding,

 ask a health care professional before use

Keep out of reach of children.

 In case of overdose, get medical help or contact a Poison Control Center right away.

Directions

  • adults: swallow with water 1 or 2 softgels as needed after meals and at bedtime
  • do not exceed 4 softgels in 24 hours except under the advice and supervision of a physician

Other information

  • store at controlled room temperature 15°-30°C (59°-86°F)
  • protect from heat and moisture

Inactive Ingredients

D&C Yellow #10, edible ink, FDandC Blue #1, FDandC Red #40, gelatin, glycerin, peppermint oil, purified water, sorbitol special, and titanium dioxide

Questions or comments?

1-800-632-6900

Principal Display Panel

Compare to the active ingredient in Extra Strength Gas-X® *See back panel

KROGER®

Gas Relief Extra Strength

  • Anti- Gas

Simethicone 125mg

Relieves Gas

  • Discomfort
  • Pressure
  • Bloating

*Gas- X® is a registered trademark of Novartis Consumer Health Inc., Parsipanny, NJ 07054-0622. Novartis Consumer Health Inc., is not affiliated with The Kroger Co. or this product

DISTRIBUTED BY THE KROGER CO., CINCINNATI, OHIO 45202

EACH DOSE IS INDIVIDUALLY SEALED IN A BLISTER PACK.

DO NOT USE IF BLISTER UNIT IS TORN OR BROKEN.

KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION

Kroger gas relief simethicone 125 mg

Gas Relief Simethicone


GAS RELIEF 
simethicone capsule, liquid filled
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:30142-550
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)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
GELATIN (UNII: 2G86QN327L)  
GLYCERIN (UNII: PDC6A3C0OX)  
PEPPERMINT OIL (UNII: AV092KU4JH)  
WATER (UNII: 059QF0KO0R)  
SORBITOL (UNII: 506T60A25R)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
Product Characteristics
ColorGREEN (GREEN) Scoreno score
ShapeOVAL (OVAL) Size9mm
FlavorImprint Code PO
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:30142-550-302 in 1 BOX03/13/201003/31/2019
115 in 1 BLISTER PACK; Type 0: Not a Combination Product
2NDC:30142-550-604 in 1 BOX03/13/201003/31/2019
215 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart33203/13/201003/31/2019
Labeler - The Kroger Co. (006999528)

Revised: 12/2018
Document Id: aad379f9-4065-4d6d-9fbc-77a25624a1c0
Set id: fa7dbda5-4c9c-403e-9bf8-08f2e1805242
Version: 2
Effective Time: 20181218
 
The Kroger Co.