MAXIMUM STRENGTH GAS RELIEF SOFTGEL- simethicone capsule, liquid filled

Maximum Strength Gas Relief Softgel by

Drug Labeling and Warnings

Maximum Strength Gas Relief Softgel by is a Otc medication manufactured, distributed, or labeled by Cardinal Health 110, LLC. DBA Leader. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

SPL UNCLASSIFIED SECTION

LEADER™

Relieves:
  Bloating
  Pressure
  Fullness

COMPARE TO PHAZYME® MAXIMUM STRENGTH active ingredient*

100% Money Back Guarantee 

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® Maximum Strength.

DISTRIBUTED BY
CARDINAL HEALTH
DUBLIN, OHIO 43017
www.myleader.com
1-800-200-6313

©2023 CARDINAL HEALTH, LEADER, and LOGOs are trademarks of Cardinal Health. All other marks are the property of their respective owners.

Product of United Arab Emirates

Packaging

INGREDIENTS AND APPEARANCE

MAXIMUM STRENGTH GAS RELIEF SOFTGEL 
simethicone capsule, liquid filled

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70000-0632
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, 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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70000-0632-1	1 in 1 CARTON	02/20/2023
1		60 in 1 BOTTLE; 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	02/20/2023

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