MAXIMUM STRENGTH GAS RELIEF- simethicone capsule, liquid filled

Maximum Strength Gas Relief by

Drug Labeling and Warnings

Maximum Strength Gas Relief by is a Otc medication manufactured, distributed, or labeled by FOODHOLD U.S.A., LLC, Humanwell PuraCap Pharmaceutical (Wuhan) Co., Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient (in each softgel)

Simethicone 250 mg

Purpose

Anti-gas

Use

• relieves bloating, pressure or fullness commonly referred to as gas

Warnings

Stop use and ask a doctor if

condition persists

Keep out of reach of children.

Directions

• swallow one or two softgels after a meal
• do not exceed two softgels per 24 hours except under the advice and supervision of a physician

Other information

• store at room temperature 59°-86°F (15°-30°C)

Inactive ingredients

D&C red #33, FD&C blue #1, gelatin, glycerin, purified water, and white edible ink

Questions or comments?

Call: 1-855-215-8180

PRINCIPAL DISPLAY PANEL

CAREONE MAXIMUM STRENGTH GAS RELIEF

SIMETHICONE 250 mg

Anti-gas

NDC: 41520-983-02

Compare to the active ingredient in PHAZYME® Maximum Strength

12 Liquid-Filled SoftGels

INGREDIENTS AND APPEARANCE

MAXIMUM STRENGTH GAS RELIEF 
simethicone capsule, liquid filled

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 41520-983
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)
WATER (UNII: 059QF0KO0R)

Product Characteristics
Color	purple (clear)	Score	no score
Shape	capsule (oval)	Size	13mm
Flavor		Imprint Code	PC31
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 41520-983-02	1 in 1 CARTON	10/05/2016
1		12 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 final	part332	10/05/2016

Labeler - FOODHOLD U.S.A., LLC (809183973)

Establishment
Name	Address	ID/FEI	Business Operations
Humanwell PuraCap Pharmaceutical (Wuhan) Co., Ltd.		421293287	manufacture(41520-983) , analysis(41520-983)