HEALTHY ACCENTS GAS RELIEF- simethicone capsule, liquid filled
DZA Brands LLC

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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DZA Brands, LLC Gas Relief 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

Warnings

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 20-25°C (68-77°F)
•: protect from light, heat and moisture

Inactive ingredients

D&C yellow #10, edible ink, FD&C blue #1, FD&C red #40, gelatin, glycerin, peppermint oil, purified water, sorbitol sorbitan solution, titanium dioxide

Questions or comments?

1-866-322-2439

Principal Display Panel

Compare to Gas-X® Extra Strength active ingredient

extra strength

gas relief

anti-gas – simethicone 125mg

relieves gas fast

pressure

bloating

discomfort

actual size

20 softgels

NO GLUTEN

HEALTHY ACCENTS GAS RELIEF
simethicone capsule, liquid filled

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:55316-428
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O)	DIMETHICONE	125 mg

Ingredient Name	Strength
Inactive Ingredients
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
FD&C RED NO. 40 (UNII: WZB9127XOA)
GELATIN, UNSPECIFIED (UNII: 2G86QN327L)
GLYCERIN (UNII: PDC6A3C0OX)
PEPPERMINT OIL (UNII: AV092KU4JH)
WATER (UNII: 059QF0KO0R)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Product Characteristics
Color	GREEN	Score	no score
Shape	OVAL	Size	10mm
Flavor		Imprint Code	L428
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:55316-428-60	20 in 1 CARTON	08/21/2009	03/30/2019
1		1 in 1 BLISTER PACK; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part332	01/29/2008	03/30/2019

Labeler - DZA Brands LLC (090322194)

Revised: 1/2021

Document Id: 65be7bfd-a32e-4924-b76e-76513e3acd32

Set id: 27b77698-ef8e-43a0-8bc8-4ae0432d48ae

Version: 4

Effective Time: 20210111

DZA Brands LLC