PHAZYME simethicone capsule gelatin coated

Krajina: Spojené štáty

Jazyk: angličtina

Zdroj: NLM (National Library of Medicine)

Aktívna zložka:

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

Dostupné z:

Preferred Pharmaceuticals, Inc.

INN (Medzinárodný Name):

DIMETHICONE

Zloženie:

DIMETHICONE 180 mg

Typ predpisu:

OTC DRUG

Stav Autorizácia:

OTC monograph final

Súhrn charakteristických

PHAZYME- SIMETHICONE CAPSULE, GELATIN COATED
PREFERRED PHARMACEUTICALS, 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._
----------
PHAZYME ANTI-GAS
_DRUG FACTS_
_ACTIVE INGREDIENT_
_(IN EACH SOFTGEL)_
Simethicone 180mg
_PURPOSE_
Anti-gas
_USE_
relieves bloating, pressure or fullness commonly referred to as gas
_WARNINGS_
STOP USE AND ASK A DOCTOR IF
condition persists
KEEP OUT OF REACH OF CHILDREN.
_DIRECTIONS_
•
•
_OTHER INFORMATION_
•
_INACTIVE INGREDIENTS_
FD&C Yellow No. 6, Gelatin, Glycerin, White Edible Ink
_QUESTIONS?_
Call toll-free 1-855-727-4277
swallow one or two softgels after a meal
do not exceed two softgels per day except under the advice and
supervision of a physician
store at room temperature 59º - 86ºF (15º - 30ºC)
PHAZYME
simethicone capsule, gelatin coated
PRODUCT INFORMATION
PRODUCT T YPE
HUMAN OTC DRUG
ITE M CODE (SOURCE )
NDC:6 8 78 8 -9 224(NDC:0 132-0 20 8 )
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 YELLO W NO . 6 (UNII: H77VEI9 3A8 )
GELATIN, UNSPECIFIED (UNII: 2G8 6 QN327L)
GLYCERIN (UNII: PDC6 A3C0 OX)
PRODUCT CHARACTERISTICS
COLOR
ORANGE
S CORE
no sco re
S HAP E
CAPSULE
S IZ E
11mm
FLAVOR
IMPRINT CODE
PZ;18 0
CONTAINS
PACKAG ING
#
ITEM CODE
PACKAGE DESCRIPTION
MARKETING START DATE
MARKETING END DATE
1
NDC:6 8 78 8 -9 224-3
36 in 1 BOTTLE; Type 0 : No t a Co mbinatio n Pro duct
10 /14/20 14
MARKETING INFORMATION
Preferred Pharmaceuticals, Inc.
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
10 /14/20 14
LABELER -
Preferred Pharmaceuticals, Inc. (791119022)
REGISTRANT -
Preferred Pharmaceuticals, Inc. (791119022)
ESTABLISHMENT
NA