SIMETHICONE- dimethicone capsule, liquid filled

SIMETHICONE by

Drug Labeling and Warnings

SIMETHICONE by is a Otc medication manufactured, distributed, or labeled by SPIRIT PHARMACEUTICALS,LLC, SOFTGEL HEALTHCARE PVT LTD. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

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"

INGREDIENTS AND APPEARANCE

SIMETHICONE 
dimethicone capsule, liquid filled

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 68210-1902
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O)	DIMETHICONE	180 mg

Inactive Ingredients
Ingredient Name	Strength
GLYCERIN (UNII: PDC6A3C0OX)
GELATIN (UNII: 2G86QN327L)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
SORBITOL (UNII: 506T60A25R)
WATER (UNII: 059QF0KO0R)
HYPROMELLOSE (UNII: 3NXW29V3WO)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
PEPPERMINT OIL (UNII: AV092KU4JH)

Product Characteristics
Color	ORANGE	Score	no score
Shape	OVAL	Size	10mm
Flavor		Imprint Code	P10
Contains

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

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part310.545	10/01/2009

Labeler - SPIRIT PHARMACEUTICALS,LLC (179621011)

Establishment
Name	Address	ID/FEI	Business Operations
SOFTGEL HEALTHCARE PVT LTD		675584180	MANUFACTURE