SIMETHICONE- dimethicone capsule, liquid filled

Nchi: Marekani

Lugha: Kiingereza

Chanzo: NLM (National Library of Medicine)

Viambatanisho vya kazi:

DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O)

Inapatikana kutoka:

Softech Pharma Pvt. Ltd.

Njia ya uendeshaji:

ORAL

Dawa ya aina:

OTC DRUG

Matibabu dalili:

Antigas Relieves bloating, pressure or fullness commonly referred to as gas

Idhini hali ya:

OTC monograph final

Tabia za bidhaa

SIMETHICONE - DIMETHICONE CAPSULE, LIQUID FILLED
SOFTECH PHARMA PVT. LTD.
_Disclaimer: Most OTC drugs are not reviewed and approved by FDA,
however they may be marketed if they_
_comply with applicable regulations and policies. FDA has not
evaluated whether this product complies._
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SIMETHICONE CAPSULES 180 MG
ACTIVE INGREDIENT (IN EACH SOFTGEL)
Simethicone 180 mg
PURPOS E
Antigas
US ES
Relieves bloating, pressure or fullness commonly referred to as gas
WARNINGS
STOP USE AND ASK DOCTOR IF CONDITION PERSISTS
Keep out of Reach of Children
DIRECTIONS
Swallow one or two softgels as needed after a meal
Do not exceed two softgels per day except under the advise and
supervision of a physician
OTHER INFORMATION
Each softgel contains: potassium 5 mg
Store at 20 - 25 C
INACTIVE INGREDIENTS:
FD and C Red No. 40, FD and C yellow No. 6, Gelatin, Glycerol
0
0
SIMETHICONE
dimethicone capsule, liquid filled
PRODUCT INFORMATION
PRODUCT T YPE
HUMAN OTC DRUG
ITE M CODE (SOURCE )
NDC:48 76 9 -112
ROUTE OF ADMINISTRATION
ORAL
ACTIVE INGREDIENT/ACTIVE MOIETY
INGREDIENT NAME
BASIS OF STRENGTH
STRE NG TH
DIMETHICO NE (UNII: 9 2RU3N3Y1O) (DIMETHICONE - UNII:9 2RU3N3Y1O)
DIMETHICONE
18 0 mg
INACTIVE INGREDIENTS
INGREDIENT NAME
STRE NG TH
FD&C RED NO . 4 0 (UNII: WZB9 127XOA)
FD&C YELLO W NO . 6 (UNII: H77VEI9 3A8 )
GELATIN (UNII: 2G8 6 QN327L)
GLYCERIN (UNII: PDC6 A3C0 OX)
Softech Pharma Pvt. Ltd.
PRODUCT CHARACTERISTICS
COLOR
re d
S CORE
no sco re
S HAP E
OVAL
S IZ E
8 mm
FLAVOR
IMPRINT CODE
RP112
CONTAINS
PACKAG ING
#
ITEM CODE
PACKAGE DESCRIPTION
MARKETING START DATE
MARKETING END DATE
1
NDC:48 76 9 -112-9 9
10 0 0 in 1 BAG
MARKETING INFORMATION
MARKE TING CATE GORY
APPLICATION NUMBE R OR MONOGRAPH CITATION
MARKE TING START DATE
MARKE TING END DATE
OTC mo no graph final
pa rt332
0 1/15/20 12
LABELER -
Softech Pharma Pvt. Ltd. (677111277)
ESTABLISHMENT
NAME
AD D RE S S
ID/FEI
BUSINE SS OPE RATIONS
So ftech Pharma Pvt. Ltd.
6 77111277
ma nufa c ture
Revised: 6/2012