SIMETHICONE tablet, chewable

Land: Vereinigte Staaten

Sprache: Englisch

Quelle: NLM (National Library of Medicine)

Wirkstoff:

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

Verfügbar ab:

Advance Pharmaceutical Inc.

INN (Internationale Bezeichnung):

DIMETHICONE

Zusammensetzung:

DIMETHICONE 125 mg

Verabreichungsweg:

ORAL

Verschreibungstyp:

OTC DRUG

Anwendungsgebiete:

Antiflatulent relieves - bloating - pressure - discomfort of gas which can be caused by certain foods or air swallowing

Berechtigungsstatus:

OTC monograph final

Fachinformation

SIMETHICONE- SIMETHICONE TABLET, CHEWABLE
ADVANCE PHARMACEUTICAL 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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GAS RELIEF SIMETHICONE 125 MG
ACTIVE INGREDIENT
(IN EACH CHEWABLE TABLET)
Simethicone 125 mg
PURPOS E
Antiflatulent
US ES
relieves
bloating
pressure
discomfort of gas which can be caused by certain foods or air
swallowing
WARNINGS
IF PREGNANT OR BREAST-FEEDING, ask a health professional before use.
KEEP OUT OF REACH OF CHILDREN
DIRECTIONS
chew thoroughly 1 to 2 tablets as needed after meals and at bed time.
do not exceed 6 tablets per day unless directed by a physician
OTHER INFORMATION
store at room temperature 15-30 °C (59-86 °F)
protect from moisture
INACTIVE INGREDIENTS
dextrose, dipac sugar, maltodextrin, microcrystalline cellulose,
peppermint flavor, silicon dioxide,
sorbitol, stearic acid
QUESTIONS OR COMMENTS
TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS
BROKEN OR MISSING
CALL 631-981-4600, 8.30 AM – 4.30 PM EST MONDAY - FRIDAY
PACKAGE LABEL
NDC: 17714-040-60 – 60 CHEWABLE TABLETS
SIMETHICONE
simethicone tablet, chewable
PRODUCT INFORMATION
PRODUCT T YPE
HUMAN OTC DRUG
ITE M CODE (SOURCE )
NDC:17714-0 40
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
DEXTRO SE (UNII: IY9 XDZ35W2)
SUCRO SE (UNII: C151H8 M554)
MICRO CRYSTALLINE CELLULO SE (UNII: OP1R32D6 1U)
MALTO DEXTRIN (UNII: 7CVR7L4A2D)
PEPPERMINT (UNII: V9 5R5KMY2B)
SILICO N DIO XIDE (UNII: ETJ7Z6 XBU4)
SO RBITO L (UNII: 50 6 T6 0 A25R)
STEARIC ACID (UNII: 4ELV7Z6 5AP)
PRODUCT CHARACTERISTICS
COLOR
white
S CORE
2 pieces
S HAP E
ROUND
S IZ E
16 mm
Advance Pharmaceutical Inc.
FLAVOR
PEPPERMINT
IMPRINT CODE
AP;0 40
CONTAINS
PACKAG ING
#
ITEM CODE
PACKAGE DESC