EXTRA STRENGTH GAS RELIEF- simethicone capsule

Drug Labeling and Warnings

Drug Details [pdf]

Drug Facts

.

Active ingredient (in each softgel)

Simethicone 125 mg

Purpose

Antigas

Use

for the relief of

• pressure, bloating and fullness commonly referred to as gas

Warning

.

Keep out of reach of children.

-

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 information

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

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 or comments?

Call 1-877-290-4008

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

EXTRA STRENGTH GAS RELIEF 
simethicone capsule

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 85828-722
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)
GELATIN (UNII: 2G86QN327L)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
SORBITOL SOLUTION (UNII: 8KW3E207O2)
SORBITAN (UNII: 6O92ICV9RU)
PEPPERMINT OIL (UNII: AV092KU4JH)
GLYCERIN (UNII: PDC6A3C0OX)
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
SHELLAC (UNII: 46N107B71O)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
WATER (UNII: 059QF0KO0R)

Product Characteristics
Color	green	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: 85828-722-30	2 in 1 CARTON	03/25/2026
1		15 in 1 BLISTER PACK; 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	03/25/2026

Labeler - Grocery Outlet, Inc. (029161585)

Registrant - TIME CAP LABORATORIES, INC. (037052099)

Establishment
Name	Address	ID/FEI	Business Operations
MARKSANS PHARMA LIMITED		925822975	manufacture(85828-722)