MAXIMUM STRENGTH GAS RELIEF SOFTGEL- simethicone capsule, liquid filled
Cardinal Health 110, LLC. DBA Leader

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 Softgel

Drug Facts

Active ingredient (in each softgel)

Simethicone 250 mg

Purpose

Anti-gas

Uses

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

Warnings

Stop use and ask a doctor if condition persists.

If pregnant or breast-feeding, ask a health professional before use.

Keep out of reach of children.

Directions

• Swallow one or two softgels as symptoms occur
• do not exceed 2 softgels per 24 hours except under the advice and supervision of a physician

Other information

• store at room temperature 20-25°C (68-77°F)
• protect from heat, humidity and light

Inactive ingredients

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

Questions or comments?

1-888-577-8033 Monday- Friday 8am - 4pm EST

*Compare to the active Ingredient in Maximum Strength Phazyme®

Relieves:
Bloating
Pressure
Fullness

TAMPER EVIDENT: DO NOT USE IF PRINTED SEAL UNDER CAP IS CUT TORN OR MISSING

*This product is not manufactured or distributed by C.B. Fleet Company Inc., distributor of PHAZYME®.

Product of UAE
Packaged and Quality Assured in the USA

DISTRIBUTED BY: CARDINAL HEALTH,
DUBLIN, OHIO 43017

www.myleader.com 1-800-200-6313

Packaging

Cardnl-antigas1

MAXIMUM STRENGTH GAS RELIEF SOFTGEL
simethicone capsule, liquid filled

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:70000-8130
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, UNSPECIFIED (UNII: 2G86QN327L)
GLYCERIN (UNII: PDC6A3C0OX)
WATER (UNII: 059QF0KO0R)

Product Characteristics
Color	purple	Score	no score
Shape	OVAL	Size	12mm
Flavor		Imprint Code	813
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:70000-8130-6	1 in 1 CARTON	11/01/2022	02/09/2023
1		60 in 1 BOTTLE; 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	11/01/2022	02/09/2023

Labeler - Cardinal Health 110, LLC. DBA Leader (063997360)

Revised: 2/2023

Document Id: 0c47a270-0bc9-4494-a58d-26a742f37ea6

Set id: 6f37f540-a08d-4122-bc86-3f2cf6792a1e

Version: 3

Effective Time: 20230223

Cardinal Health 110, LLC. DBA Leader