SIMETHICONE 250MG MAXIMUM STRENGTH GAS RELIEF- simethicone 250 mg capsule, liquid filled

Simethicone 250MG Maximum Strength Gas Relief by

Drug Labeling and Warnings

Simethicone 250MG Maximum Strength Gas Relief by is a Otc medication manufactured, distributed, or labeled by One2Zee Limited Liability Company. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

ACTIVE INGREDIENT

Active Ingredients (in each softgel)

Simethicone 250 mg

PURPOSE

Purpose

Antigas

INDICATIONS & USAGE

Use for the relief of

• pressure
• bloating
• fullness
• commonly referred to as gas

Warning

• Stop use and ask doctor if condition persists.
• If pregnant or breast-feeding, ask a health professional before use.

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 4 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)
• protact from light, heat and moisture
• do not use if imprinted safety seal under cap is broken or missing

INACTIVE INGREDIENT

D&C Red #33, FD&C Blue #1, gelatin, glycerin, povidone, purified water, sorbitol solution, titanium dioxide

QUESTIONS

Questions or comments?
Call 1-833-663-2933

Bottle Label

INGREDIENTS AND APPEARANCE

SIMETHICONE 250MG MAXIMUM STRENGTH GAS RELIEF 
simethicone 250 mg capsule, liquid filled

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 55629-023
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O)	DIMETHICONE	250 mg

Inactive Ingredients
Ingredient Name	Strength
D&C RED NO. 33 (UNII: 9DBA0SBB0L)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
GELATIN (UNII: 2G86QN327L)
GLYCERIN (UNII: PDC6A3C0OX)
POVIDONE (UNII: FZ989GH94E)
WATER (UNII: 059QF0KO0R)
SORBITOL SOLUTION (UNII: 8KW3E207O2)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Product Characteristics
Color	purple	Score	no score
Shape	OVAL	Size	5mm
Flavor		Imprint Code	Z50
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 55629-023-01	300 in 1 BOTTLE; Type 0: Not a Combination Product	09/24/2024

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M	09/24/2024

Labeler - One2Zee Limited Liability Company (078656111)