WINCO FOODS GAS RELIEF EXTRA STRENGTH SOFTGELS- simethicone capsule, liquid filled

WinCo Foods Gas Relief by

Drug Labeling and Warnings

WinCo Foods Gas Relief by is a Otc medication manufactured, distributed, or labeled by WinCo Foods, LLC, Reese Pharmaceutical Co, Swiss Caps Romania. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient (in each softgel)

Simethicone 125mg

Purpose

Antigas

Use

for the relief of

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

Warnings 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 20-25ºC (68-77ºF)
• protect from light, heat, and moisture

Inactive ingredients

D&C yellow 10, FD&C blue 1, FD&C red 40, gelatin, glycerin, hypromellose, peppermint oil, sorbitan, sorbitol, titanium dioxide

Questions or comments?

800-935-2362

Principal Display Panel

INGREDIENTS AND APPEARANCE

WINCO FOODS GAS RELIEF  EXTRA STRENGTH SOFTGELS
simethicone capsule, liquid filled

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 67091-379
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
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
FD&C RED NO. 40 (UNII: WZB9127XOA)
GELATIN TYPE B BOVINE (230 BLOOM) (UNII: WIL1404U79)
GLYCERIN (UNII: PDC6A3C0OX)
PEPPERMINT OIL (UNII: AV092KU4JH)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
SORBITOL (UNII: 506T60A25R)

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 67091-379-30	2 in 1 CARTON	12/02/2020
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	12/02/2020

Labeler - WinCo Foods, LLC (056098817)

Registrant - Reese Pharmaceutical Co (004172052)

Establishment
Name	Address	ID/FEI	Business Operations
Swiss Caps Romania		565466997	manufacture(67091-379)