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 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"

INGREDIENTS AND APPEARANCE

SIMETHICONE 
dimethicone capsule, liquid filled

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 68210-1901
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O)	DIMETHICONE	125 mg

Inactive Ingredients
Ingredient Name	Strength
GLYCERIN (UNII: PDC6A3C0OX)
GELATIN (UNII: 2G86QN327L)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
WATER (UNII: 059QF0KO0R)
FD&C RED NO. 3 (UNII: PN2ZH5LOQY)
PEPPERMINT OIL (UNII: AV092KU4JH)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)

Product Characteristics
Color	GREEN	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: 68210-1901-1	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
OTC MONOGRAPH FINAL	part332	03/01/2010

Labeler - SPIRIT PHARMACEUTICALS,LLC (179621011)

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