SIMETHICONE- simethicone capsule, gelatin coated 
Spirit Pharmaceuticals LLC

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ULTRA STRENGTH GAS RELIEF

Drug Facts

Active ingredient (in each softgel)

Simethicone 180 mg

Purpose

Antigas

Use

for the relief of
■ pressure and bloating commonly referred to as gas

Warnings

Keep out of reach of children.

Keep out of reach of children.

Directions

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

Other information

■ store at controlled room temperature 20-25°C (68-77°F)
■ protect from heat and moisture

Inactive ingredients

FD&C yellow#6, gelatin, glycerin, peppermint oil, povidone, purified water, sorbitol solution, titanium dioxide

Questions or comments?

1-888-333-9792

PRINCIPAL DISPLAY PANEL

image description

SIMETHICONE 
simethicone capsule, gelatin coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68210-4154
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE180 mg
Inactive Ingredients
Ingredient NameStrength
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
GELATIN (UNII: 2G86QN327L)  
GLYCERIN (UNII: PDC6A3C0OX)  
PEPPERMINT OIL (UNII: AV092KU4JH)  
POVIDONE K30 (UNII: U725QWY32X)  
WATER (UNII: 059QF0KO0R)  
SORBITOL SOLUTION (UNII: 8KW3E207O2)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
Product Characteristics
Colororange (OPAQUE) Scoreno score
ShapeOVALSize15mm
FlavorImprint Code 161
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:68210-4154-22 in 1 CARTON04/29/2021
110 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM00204/29/2021
Labeler - Spirit Pharmaceuticals LLC (179621011)

Revised: 12/2023
Document Id: 0c02caa3-b64b-8bbe-e063-6394a90a6499
Set id: 28cd4c11-6ce2-4cb8-b916-d6528fb63fa9
Version: 4
Effective Time: 20231208
 
Spirit Pharmaceuticals LLC