Sanafitil Extra Strength (Simethicone) Capsule, Liquid Filled [Promex Llc] -

SANAFITIL EXTRA STRENGTH (SIMETHICONE) CAPSULE, LIQUID FILLED [PROMEX LLC]
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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

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

Ingredient Name	Strength
Inactive Ingredients
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)

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

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

Labeler - Promex LLC (789974388)

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