PLUSPHARMA simethicone tablet chewable

Land: Vereinigte Staaten

Sprache: Englisch

Quelle: NLM (National Library of Medicine)

Wirkstoff:

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

Verfügbar ab:

Avera McKennan Hospital

INN (Internationale Bezeichnung):

DIMETHICONE

Zusammensetzung:

DIMETHICONE 80 mg

Verschreibungstyp:

OTC DRUG

Berechtigungsstatus:

OTC monograph final

Fachinformation

PLUSPHARMA - SIMETHICONE TABLET, CHEWABLE
AVERA MCKENNAN HOSPITAL
_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._
----------
DRUG FACTS
ACTIVE INGREDIENT (IN EACH TABLET)
Simethicone 80 mg, USP
PURPOS E
Anti-Gas
US ES
Relieves bloating and pressure commonly referred to as gas.
WARNINGS
IF PREGNANT OR BREAST-FEEDING, ask a health professional before use.
KEEP THIS AND ALL DRUGS OUT OF THE REACH OF CHILDREN.
DIRECTIONS
Adults: Chew 1 or 2 tablets as needed after meals and at bedtime.
Do not exceed 6 tablets per day except under the advice and
supervision of a physician.
OTHER INFORMATION
Store at room temperature.
Avoid high humidity.
DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING.
INACTIVE INGREDIENTS
Fructose, Maltodextrin, Natural and Artificial Spearmint Flavor,
Silicon Dioxide, Sorbitol, Starch and
Stearic Acid.
QUES TIONS ?
If you have any questions or comments, or to report an adverse event,
please contact [phone].
PRINCIPAL DISPLAY PANEL
PLUSPHARMA
simethicone tablet, chewable
PRODUCT INFORMATION
PRODUCT T YPE
HUMAN OTC DRUG
ITE M CODE (SOURCE )
NDC:6 9 18 9 -0 8 6 0 (NDC:516 45-8 6 0 )
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
8 0 mg
INACTIVE INGREDIENTS
INGREDIENT NAME
STRE NG TH
FRUCTO SE (UNII: 6 YSS42VSEV)
MALTO DEXTRIN (UNII: 7CVR7L4A2D)
SILICO N DIO XIDE (UNII: ETJ7Z6 XBU4)
SO RBITO L (UNII: 50 6 T6 0 A25R)
STARCH, CO RN (UNII: O8 232NY3SJ)
STEARIC ACID (UNII: 4ELV7Z6 5AP)
PRODUCT CHARACTERISTICS
Avera McKennan Hospital
PRODUCT CHARACTERISTICS
COLOR
white
S CORE
no sco re
S HAP E
ROUND (Ro und Flat Faced Beveled Edge)
S IZ E
13mm
FLAVOR
SPEARMINT (Natural and Artificial)
IMPRINT CODE
GPI;LB
CONTAINS
PACKAG ING
#
ITEM CODE
PACKAGE DESCRIPTION
MARKETING START DATE
MARKETING END D