GAS RELIEF EXTRA STRENGTH- simethicone capsule, liquid filled

Country: Amerika Syarikat

Bahasa: Inggeris

Sumber: NLM (National Library of Medicine)

Bahan aktif:

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

Boleh didapati daripada:

Kareway Product, Inc.

INN (Nama Antarabangsa):

DIMETHICONE

Komposisi:

DIMETHICONE 125 mg

Laluan pentadbiran:

ORAL

Jenis preskripsi:

OTC DRUG

Tanda-tanda terapeutik:

Antiflatulent For Relief of: - Bloating - Pressure - Fullness - stuffed feeling commonly referred to as gas

Status kebenaran:

OTC monograph final

Ciri produk

GAS RELIEF EXTRA STRENGTH- SIMETHICONE CAPSULE, LIQUID FILLED
KAREWAY PRODUCT, INC.
_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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DRUG FACTS
ACTIVE INGREDIENTS (IN EACH SOFTGEL)
Simethicone 125mg
PURPOS E
Antiflatulent
US ES
For Relief of:
Bloating
Pressure
Fullness
stuffed feeling commonly referred to as gas
WARNINGS
STOP USE AND ASK A DOCTOR IF
condition persists
IF PREGNANT OR BREAST-FEEDING,
ask a health care professional before use.
KEEP OUT OF REACH OF CHILDREN
In case of overdose, get medical help or contact a Poison Control
Center right away.
DIRECTIONS
ADULTS: swallow with water 1 or 2 softgels as needed after meals or at
bedtime. Do not exceed 4
softgels per day, unless directed by doctor.
OTHER INFORMATION
store at a controlled room temperature 15-30°C (59-86°F)
protect from heat and moisture
INACTIVE INGREIENTS
FD&C blue 1, FD&C yellow 5, gelatin, glycerin, purified water,
titanium dioxide
PACKAGE/LABEL PRINCIPAL DISPLAY PANEL
GAS RELIEF EXTRA STRENGTH
simethicone capsule, liquid filled
PRODUCT INFORMATION
PRODUCT T YPE
HUMAN OTC DRUG
ITE M CODE (SOURCE )
NDC:6 7510 -0 172
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
125 mg
INACTIVE INGREDIENTS
INGREDIENT NAME
STRE NG TH
FD&C BLUE NO . 1 (UNII: H3R47K3TBD)
FD&C YELLO W NO . 5 (UNII: I753WB2F1M)
Kareway Product, Inc.
GELATIN (UNII: 2G8 6 QN327L)
GLYCERIN (UNII: PDC6 A3C0 OX)
WATER (UNII: 0 59 QF0 KO0 R)
TITANIUM DIO XIDE (UNII: 15FIX9 V2JP)
PRODUCT CHARACTERISTICS
COLOR
gre e n
S CORE
no sco re
S HAP E
OVAL
S IZ E
9 mm
FLAVOR
IMPRINT CODE
GR
CONTAINS
PACKAG ING
#
ITEM CODE
PACKAGE DESCRIPTION
MARKETING START DATE
MARKETING END DATE
1
NDC:6 7510 -0 172-1
10 in 1 BLISTER PACK
MARKETING INFORMATION
MARKE TING CATE GORY
APPLICATION NUMBE R OR MONOG