GAS RELIEF- simethicone capsule

Gas Relief by

Drug Labeling and Warnings

Gas Relief by is a Otc medication manufactured, distributed, or labeled by H-E-B, TIME CAP LABS 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

Anti-gas

INDICATIONS & USAGE

Use for the relief of

• pressure, bloating and fullness commonly referred to as gas

WARNINGS

Warning

KEEP OUT OF REACH OF CHILDREN

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 SImethicone 125mg softgels 30ct

722T Simethicone 125mg softgels 200ct

INGREDIENTS AND APPEARANCE

GAS RELIEF 
simethicone capsule

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 37808-744
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
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)
WATER (UNII: 059QF0KO0R)
SORBITOL SOLUTION (UNII: 8KW3E207O2)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
GELATIN, UNSPECIFIED (UNII: 2G86QN327L)
PEPPERMINT OIL (UNII: AV092KU4JH)
FD&C RED NO. 40 (UNII: WZB9127XOA)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
GLYCERIN (UNII: PDC6A3C0OX)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
SHELLAC (UNII: 46N107B71O)
SORBITAN (UNII: 6O92ICV9RU)

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: 37808-744-30	2 in 1 CARTON	01/05/2026
1		15 in 1 BLISTER PACK; Type 0: Not a Combination Product
2	NDC: 37808-744-20	200 in 1 BOTTLE; Type 0: Not a Combination Product	01/05/2026

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M001	01/05/2026

Labeler - H-E-B (007924756)

Registrant - TIME CAP LABS INC (037052099)

Establishment
Name	Address	ID/FEI	Business Operations
MARKSANS PHARMA LIMITED		925822975	manufacture(37808-744)