GAS RELIEF- simethicone capsule

Gas Relief by

Drug Labeling and Warnings

Gas Relief by is a Otc medication manufactured, distributed, or labeled by BJWC (Berkley & Jensen / BJ's), TIME CAP LABORATORIES, INC., MARKSANS PHARMA LIMITED. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

Active ingredient (in each softgel)

Simethicone 125 mg

PURPOSE

Purpose

Antigas

INDICATIONS & USAGE

Use for the relief of

• pressure, bloating and fullness commonly referred to as gas

WARNINGS

Warning

Keep out of reach of children.

DOSAGE & ADMINISTRATION

Directions

• adults and children 12 years and older: 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 SAFETY INFORMATION

Other information

• store at room temperature
• protect from light, heat and moisture

INACTIVE INGREDIENT

Inactive ingredients

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

QUESTIONS

Questions or comments? Call 1-877-290-4008

PRINCIPAL DISPLAY PANEL

722T 240ct label

722T 240ct Carton

INGREDIENTS AND APPEARANCE

GAS RELIEF 
simethicone capsule

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 68391-722
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O)	DIMETHICONE	125 mg

Inactive Ingredients
Ingredient Name	Strength
FD&C RED NO. 40 (UNII: WZB9127XOA)
GLYCERIN (UNII: PDC6A3C0OX)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
SORBITOL SOLUTION (UNII: 8KW3E207O2)
WATER (UNII: 059QF0KO0R)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)
GELATIN, UNSPECIFIED (UNII: 2G86QN327L)
SORBITAN (UNII: 6O92ICV9RU)
SHELLAC (UNII: 46N107B71O)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
PEPPERMINT OIL (UNII: AV092KU4JH)

Product Characteristics
Color	green (Green, opaque)	Score	no score
Shape	OVAL	Size	10mm
Flavor		Imprint Code	105
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 68391-722-29	1 in 1 CARTON	08/20/2025
1		240 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	M001	08/20/2025

Labeler - BJWC (Berkley & Jensen / BJ's) (159082692)

Registrant - TIME CAP LABORATORIES, INC. (037052099)

Establishment
Name	Address	ID/FEI	Business Operations
MARKSANS PHARMA LIMITED		925822975	manufacture(68391-722)