Ultra Strength Gas Relief (Simethicone) Capsule, Liquid Filled [Reliable 1 Laboratories Llc] -

ULTRA STRENGTH GAS RELIEF (SIMETHICONE) CAPSULE, LIQUID FILLED [RELIABLE 1 LABORATORIES LLC]
PDF | XML

View All Sections

SPL UNCLASSIFIED SECTION

Drug Facts
Active ingredient (in each softgel)

Simethicone 180 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

Keep out of reach of children.
Directions
- swallow 1 or 2 softgels as needed after a meal
- do not exceed two softgels per day except under the advice and supervision of a physician
Other information
- store at room temperature 59º - 86ºF (15º - 30ºC)
Inactive ingredients

FD&C yellow#6, gelatin, glycerin, purified water and white edible ink
Questions or comments?

Call: 516-341-0666
PRINCIPAL DISPLAY PANEL

Ultra Strength Gas Relief

Simethicone 180 mg Anti-gas 180 Softgels

NDC 69618-045-18

*Compare to the active ingredient in PHAZYME® Ultra Strength

INGREDIENTS AND APPEARANCE

ULTRA STRENGTH GAS RELIEF
simethicone capsule, liquid filled

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O)	DIMETHICONE	180 mg

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:69618-045-18	180 in 1 BOTTLE; Type 0: Not a Combination Product	07/13/2017

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part332	07/13/2017

Labeler - RELIABLE 1 LABORATORIES LLC (079718111)

Name	Address	ID/FEI	Business Operations
Establishment
Humanwell PuraCap Pharmaceutical (Wuhan) Co., Ltd.		421293287	manufacture(69618-045) , analysis(69618-045)

View All Sections

Medic