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 180 MG

FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Drug Facts

Active ingredient (per softgel)

Simethicone 180 mg

Purpose

Antigas

Use

for the relief of

  • pressure and bloating 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 2 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 heat and moisture

Inactive ingredients

FD&C yellow 6, gelatin, glycerin, hypromellose, peppermint oil, purified water, sorbitol, titanium dioxide

PRINCIPAL DISPLAY PANEL - Shipping Label

SIMETHICONE CAPSULES USP 180MG
Each Softgel Contains:

(Simethicone USP 180 mg)

LOT NO :

MFG DATE :

GROSS WT. :

NDC NO :         68210-1902
QUANTITY :

EXP DATE :

CRTN :

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 - Shipping Label

SIMETHICONE

DIMETHICONE CAPSULE, LIQUID FILLED

Product Information

Product Type Human otc drug label Item Code (Source) NDC:68210-1902
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
DIMETHICONE 180 mg

Inactive Ingredients

Ingredient Name Strength
GLYCERIN
GELATIN
titanium dioxide
sorbitol
water
hypromellose
FD&C YELLOW NO. 6
PEPPERMINT OIL

Product Characteristics

Color Size Imprint Code Shape
ORANGE 10 mm P10 OVAL

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 10 in 1 BAG
2 30 in 1 BAG
3 1000 in 1 BAG
4 16000 in 1 BAG
5 20000 in 1 BAG
6 NDC:68210-1902-5 1 in 1 BOX

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part. part310.545 2009-10-01


PLEASE, BE CAREFUL!
Be sure to consult your doctor before taking any medication!
Copyright © 2014. drugs-library.com. All rights reserved. Information on drugs-library.com is provided for educational purposes only and is not to be used for medical advice, diagnosis or treatment.
Support info@drugs-library.com.