SIMETHICONE description, usages, side effects, indications, overdosage, supplying and lots more!

SIMETHICONE

SPIRIT PHARMACEUTICALS,LLC

  • Description
  • Clinical Pharmacology
  • Indications & Usage
  • Contraindications
  • Warnings
  • Precautions
  • Side Effects
  • Overdosage
  • Dosage & Administration
  • How Supplied
  • Patient Counseling Information
  • Supplemental Patient Material
  • Boxed Warning
  • Patient Package Insert
SIMETHICONE, CAPSULES USP 125MG

FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Drug Facts

Active ingredient (per softgel)

Simethicone 125 mg

Purpose

Antigas

Use

for the relief of

  • pressure, bloating, and fullness commonly referred to as gas

Warnings

Keep out of reach of children.

Directions

  • adults: swallow with water 1 or 2 softgels as needed after meals and at bedtime
  • do not exceed 4 softgels in 24 hours except under the advice and supervision of a physician

Other information

  • store at a controlled room temperature 20-25°C (68-77°F)
  • protect from light, heat and moisture

Inactive ingredients

D&C yellow 10, FD&C blue 1, FD&C red 40, gelatin, glycerin, hypromellose, peppermint oil, purified water, sorbitol, titanium dioxide

PRINCIPAL DISPLAY PANEL - 125 mg Label

SIMETHICONE CAPSULES USP 125MG

Each Softgel Contains:
(Simethicone USP 125 mg)

LOT NO : QUANTITY :
DRUM NO : NDC NO : 68210-1901-
MFG DATE : EXP DATE :

WARNING:
KEEP OUT OF REACH OF CHILDREN

STORE CONTROLLED ROOM TEMPERATURE OF 59° – 86°F (15° – 30°C)
PROTECT FROM LIGHT, MOISTURE AND FREEZING

THIS IS A BULK SHIPMENT INTENDED FOR FURTHER PROCESSING ONLY.
CONTENTS SHOULD BE APPROVED, REPACKAGED IMMEDIATELY AND LABELED IN STRICT
CONFORMANCE WITH THE F.D&C ACT AND REGULATIONS THEREUNDER.

MANUFACTURED BY:
SOFTGEL HEALTHCARE PVT LIMITED
INDIA
LABELLER CODE           : 35916
LIC NO.                              : TN/DRUGS/00002124

MANUFACTURED FOR:
SPIRIT PHARMACEUTICALS LLC
225 LINCOLN HWY, STE 205
FAIRLESS HILLS, PA 19030
PH.# 215 943 4000
FAX.# 215 943 4039

CAUTION : "FOR MANUFACTURING, PROCESSING OR REPACKING"

PRINCIPAL DISPLAY PANEL - 125 mg Label

SIMETHICONE

DIMETHICONE CAPSULE, LIQUID FILLED

Product Information

Product Type Human otc drug label Item Code (Source) NDC:68210-1901
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
DIMETHICONE 125 mg

Inactive Ingredients

Ingredient Name Strength
GLYCERIN
GELATIN
titanium dioxide
water
FD&C RED NO. 3
PEPPERMINT OIL
FD&C BLUE NO. 1

Product Characteristics

Color Size Imprint Code Shape
GREEN 10 mm P10 OVAL

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:68210-1901-1 10 in 1 BOX
2 NDC:68210-1901-2 30 in 1 BOX
3 NDC:68210-1901-3 1000 in 1 BOX
4 NDC:68210-1901-4 16000 in 1 BOX
5 NDC:68210-1901-5 20000 in 1 BOX

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part332 2010-03-01


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