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Simethicone

Softech Pharma Pvt. Ltd

Simethicone Capsules, 125 mg


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Active ingredient (per soft gel)

Simethicone 125 mg

Purpose

Antigas

Simethicone Uses

Relieves pressure and bloating commonly referred to as gas

Warnings

Keep out of reach of children

Directions

  • Do not exceed 4 softgels in 24 hours
  • Adults: swallow with water 1 or 2 softgels as needed after meals and at bedtime

Simethicone Other information

store at 200 - 250C

Inactive ingredients

D and C yellow 10, FD and C blue 1, FD and C red 40, gelatin, glycerin, mannitol, peppermint oil, purified water, sorbitan, sorbitol, titanium dioxide

Simethicone

Keep out of Reach of Children

Simethicone

Dimethicone CAPSULE, LIQUID FILLED

Product Information

Product Type Human otc drug label Item Code (Source) NDC:48769-113
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
DIMETHICONE 125 mg

Inactive Ingredients

Ingredient Name Strength
D&C YELLOW NO. 10
FD&C BLUE NO. 1
FD&C RED NO. 40
GELATIN
GLYCERIN
mannitol
PEPPERMINT OIL
water
SORBITAN
sorbitol
titanium dioxide

Product Characteristics

Color Size Imprint Code Shape
green 5 mm RP113 OVAL

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:48769-113-99 5000 in 1 BAG

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part332 2012-01-15


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