SIMETHICONE tablet, chewable

Land: Vereinigte Staaten

Sprache: Englisch

Quelle: NLM (National Library of Medicine)

Wirkstoff:

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

Verfügbar ab:

Richmond Pharmaceuticals, Inc.

INN (Internationale Bezeichnung):

DIMETHICONE

Zusammensetzung:

DIMETHICONE 80 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
RICHMOND 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._
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GAS RELIEF SIMETHICONE
DRUG FACTS
.
ACTIVE INGREDIENT
(IN EACH CHEWABLE TABLET)
Simethicone 80 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 doctor
OTHER INFORMATION
store at room temperature 15-30 °C (59-86 °F)
protect from moisture
INACTIVE INGREDIENTS
dextrose, dipac sugar, maltodextrin, peppermint flavor, sorbitol,
stearic acid
QUESTIONS OR COMMENTS
TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS
BROKEN OR MISSING
CALL 804-270-4498, 8.30 AM – 4.30 PM EST Monday - Friday
PACKAGE LABEL
NDC: 54738-518-01
– 100 CHEWABLE
TABLETS
SIMETHICONE
simethicone tablet, chewable
PRODUCT INFORMATION
PRODUCT T YPE
HUMAN OTC DRUG
ITE M CODE (SOURCE )
NDC:54738 -518
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
DEXTRO SE (UNII: IY9 XDZ35W2)
SUCRO SE (UNII: C151H8 M554)
MALTO DEXTRIN (UNII: 7CVR7L4A2D)
PEPPERMINT (UNII: V9 5R5KMY2B)
SO RBITO L (UNII: 50 6 T6 0 A25R)
STEARIC ACID (UNII: 4ELV7Z6 5AP)
PRODUCT CHARACTERISTICS
COLOR
white
S CORE
no sco re
Richmond Pharmaceuticals, Inc.
S HAP E
ROUND
S IZ E
13mm
FLAVOR
PEPPERMINT
IMPRINT CODE
AP;0 19
CONTAINS
PACKAG ING
#
ITEM CODE
PACKAGE DESCRIPTION
MARKETING START DATE
MARKETING END DATE
1
NDC:54738 -518 -0 1
10 0 in 1 BOTTLE; Type 0 : No t a Co mbinatio n Pro d