SANAFITIL EXTRA STRENGTH- simethicone capsule, liquid filled

Sanafitil by

Drug Labeling and Warnings

Sanafitil by is a Otc medication manufactured, distributed, or labeled by Promex LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredients (in each softgel)

Simethicone 125mg

Purpose

Antiflatulent

Uses

For Relief of:

• Bloating
• Pressure
• Fullness
• stuffed feeling commonly referred to as gas

Warnings

Stop use and ask a doctor if

condition persists

If pregnant or breast-feeding,

ask a health care professional before use.

Keep out of reach of children

In case of overdose, get medical help or contact a Poison Control Center right away.

Directions

• adults: swallow with water 1 or 2 softgels as needed after meals or at bedtime. Do not exceed 4 softgels per day, unless directed by doctor.

Other information

• store at a controlled room temperature 15-30°C (59-86°F)
• protect from heat and moisture

Inactive ingreients

FD&C blue 1, FD&C yellow 5, gelatin, glycerin, purified water, titanium dioxide

Package/Label Principal Display Panel

INGREDIENTS AND APPEARANCE

SANAFITIL  EXTRA STRENGTH
simethicone capsule, liquid filled

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58988-0027
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O)	DIMETHICONE	125 mg

Inactive Ingredients
Ingredient Name	Strength
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
GELATIN (UNII: 2G86QN327L)
GLYCERIN (UNII: PDC6A3C0OX)
WATER (UNII: 059QF0KO0R)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Product Characteristics
Color	green	Score	no score
Shape	OVAL	Size	9mm
Flavor		Imprint Code	GR
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58988-0027-1	10 in 1 BLISTER PACK

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part332	01/08/2014

Labeler - Promex LLC (789974388)