MAXIMUM STRENGTH GAS RELIEF- simethicone capsule, liquid filled
FOODHOLD U.S.A., 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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MAXIMUM STRENGTH GAS RELIEF

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

CAREONE Max Strength Gas Relief 12ct

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

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

Ingredient Name	Strength
Inactive Ingredients
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

#	Item Code	Package Description	Marketing Start Date
Packaging
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 Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part332	10/05/2016

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

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