Simethicone 125 MG Oral Capsule

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Pill Identifier Information of Simethicone 125 MG Oral Capsule

Drug Information

Imprint:	P10
Shape:	C48345
Color:	C48329
Ingredients:	Simethicone
Size:	10.00
Score:	1
Rxtty:	SCD
Author:	SPIRIT PHARMACEUTICALS,LLC
Inactive Ingredients:	GLYCERIN / GELATIN / TITANIUM DIOXIDE / WATER / FD&C RED NO. 3 / PEPPERMINT OIL / FD&C BLUE NO. 1>

Complete Information

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 20-25Â°C (68-77Â°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 59Â° â€“ 86Â°F (15Â° â€“ 30Â°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 Â Â Â Â Â Â Â Â Â Â : 35916
LIC NO. Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â : 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

SIMETHICONEÂ
dimethicone capsule, liquid filled

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

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

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

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

#	Item Code	Package Description
Packaging
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 Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH FINAL	part332	03/01/2010

Labeler -Â SPIRIT PHARMACEUTICALS,LLC (179621011)

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

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