SIMETHICONE capsule, gelatin coated

Simethicone by

Drug Labeling and Warnings

Simethicone by is a Otc medication manufactured, distributed, or labeled by Spirit Pharmaceuticals LLC, MEDGEL PRIVATE LIMITED. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

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

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

ULTRA STRANGTH

GAS RELIEF
Simethicone 180 mg /
anti-gas

Fast relief of:
bloating
pressure
fullness
gas

50 SOFTGELS

INGREDIENTS AND APPEARANCE

SIMETHICONE 
simethicone capsule, gelatin coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 68210-0314
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
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
GELATIN (UNII: 2G86QN327L)
GLYCERIN (UNII: PDC6A3C0OX)
PEPPERMINT OIL (UNII: AV092KU4JH)
WATER (UNII: 059QF0KO0R)
SORBITOL SOLUTION (UNII: 8KW3E207O2)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Product Characteristics
Color	orange (OPAQUE)	Score	no score
Shape	OVAL	Size	15mm
Flavor		Imprint Code	161
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 68210-0314-5	1 in 1 CARTON	03/10/2020
1		50 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 final	part332	03/10/2020

Labeler - Spirit Pharmaceuticals LLC (179621011)

Establishment
Name	Address	ID/FEI	Business Operations
MEDGEL PRIVATE LIMITED		677385498	manufacture(68210-0314)