ULTRA STRENGTH GAS RELIEF- simethicone capsule

Ultra Strength Gas Relief by

Drug Labeling and Warnings

Ultra Strength Gas Relief by is a Otc medication manufactured, distributed, or labeled by KROGER COMPANY, TIME CAP LABORATORIES, INC., MARKSANS PHARMA LIMITED. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

ACTIVE INGREDIENT

Active ingredient (in each softgel)
Simethicone 180 mg

PURPOSE

Purpose
Anti-gas

INDICATIONS & USAGE

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

WARNINGS

Warnings

Stop use and ask a doctor if condition persists.

Keep out of reach of children.

DOSAGE & ADMINISTRATION

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.

STORAGE AND HANDLING

Other information
Store at room temperature

INACTIVE INGREDIENT

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

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

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

ULTRA STRENGTH GAS RELIEF 
simethicone capsule

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 41226-717
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O)	DIMETHICONE	180 mg

Inactive Ingredients
Ingredient Name	Strength
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
SORBITOL SOLUTION (UNII: 8KW3E207O2)
GELATIN (UNII: 2G86QN327L)
GLYCERIN (UNII: PDC6A3C0OX)
PEPPERMINT OIL (UNII: AV092KU4JH)
SHELLAC (UNII: 46N107B71O)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
SORBITAN (UNII: 6O92ICV9RU)

Product Characteristics
Color	orange (Orange Translucent)	Score	no score
Shape	OVAL	Size	11mm
Flavor		Imprint Code	104
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 41226-717-30	1 in 1 CARTON	05/05/2023
1		60 in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M002	05/05/2023

Labeler - KROGER COMPANY (006999528)

Registrant - TIME CAP LABORATORIES, INC. (037052099)

Establishment
Name	Address	ID/FEI	Business Operations
MARKSANS PHARMA LIMITED		925822975	manufacture(41226-717)