OTC Medication Information: Sanafitil Extra Strength

SANAFITIL EXTRA STRENGTH- dimethicone capsule, liquid filled
Promex LLC

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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

Gas Relief
(click image for full-size original)

SANAFITIL EXTRA STRENGTH
simethicone capsule, liquid filled
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:58988-0027
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DIMETHICONE (DIMETHICONE) DIMETHICONE 125 mg
Inactive Ingredients
Ingredient Name Strength
FD&C BLUE NO. 1
FD&C YELLOW NO. 5
GELATIN
GLYCERIN
WATER
TITANIUM DIOXIDE
Product Characteristics
Color green Score no score
Shape OVAL Size 9mm
Flavor Imprint Code GR
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:58988-0027-1 10 CAPSULE, LIQUID FILLED in 1 BLISTER PACK None
Image of Product
(click image for full-size original)
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)

Revised: 01/2015 Promex LLC

Our database comes directly from the FDA’s central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA’s repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

Our database comes directly from the FDA's central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA's repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

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