SIMETHICONE capsule, liquid filled

Simethicone by

Drug Labeling and Warnings

Simethicone by is a Otc medication manufactured, distributed, or labeled by PURACAP PHARMACEUTICAL LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient

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

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?

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Package/Label Principal Display Panel – Principal Display Panel

Package/Label Principal Display Panel – Drug Facts

INGREDIENTS AND APPEARANCE

SIMETHICONE 
simethicone capsule, liquid filled

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 51013-439
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 (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: 51013-439-02	1 in 1 CARTON	03/25/2019
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	03/25/2019

Labeler - PURACAP PHARMACEUTICAL LLC (962106329)