SIMETHICONE capsule, liquid filled

Land: USA

Språk: engelsk

Kilde: NLM (National Library of Medicine)

Aktiv ingrediens:

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

Tilgjengelig fra:

ONE2ZEE LIMITED LIABILITY COMPANY

Administreringsrute:

ORAL

Resept typen:

OTC DRUG

Indikasjoner:

Anti-gas - relieves bloating, pressure or fullness commonly referred to as gas

Autorisasjon status:

OTC monograph final

Preparatomtale

SIMETHICONE- SIMETHICONE CAPSULE, LIQUID FILLED
ONE2ZEE LIMITED LIABILITY COMPANY
_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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SIMETHICONE CAPSULES 250 MG, LIQUID FILLED
ACTIVE INGREDIENT (IN EACH CAPSULE)
Simethicone 250 mg
PURPOSE
Anti-gas
USES
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
swallow one or two softgels after a meal
do not exceed two softgels per 24 hours except under the advice and
supervision of
a physician
OTHER INFORMATION
store at room temperature 59°-86°F (15°-30°C
INACTIVE INGREDIENTS
gelatin, glycerin, sorbitol, fd&c blue no. 1, fd&c red no. 40,
povidone k30, titanium
dioxide, water
PRINCIPAL DISPLAY PANEL - SHIPPING LABEL
Simethicone capsules
Each Softgel Contains:
(Simethicone 250mg)
LOT NO:
DRUM NO:
MFG DATE:
QUANTITY:
NDC NO: 55629-017-
EXP DATE:
WARNING:
KEEP OUT OF REACH OF CHILDREN
STORE CONTROLLED ROOM TEMPERATURE OF 59° - 86°F (15° - 30°C)
PROTECT FROM LIGHT, MOISTURE AND FREEZING
THIS IS A BULK SHIPMENT INTENDED FOR FURTHER PROCESSING ONLY.
CONTENTS SHOULD BE APPROVED, REPACKAGED IMMEDIATELY AND LABELED IN
STRICT CONFORMANCE WITH
THE F.D & C.ACT AND REGULATIONS THEREUNDER.
SIMETHICONE
simethicone capsule, liquid filled
PRODUCT INFORMATION
PRODUCT TYPE
HUMAN OTC DRUG
ITEM CODE (SOURCE)
NDC:55629-017
ROUTE OF ADMINISTRATION
ORAL
ACTIVE INGREDIENT/ACTIVE MOIETY
INGREDIENT NAME
BASIS OF STRENGTH
STRENGTH
DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O)
DIMETHICONE
250 mg
INACTIVE INGREDIENTS
INGREDIENT NAME
STRENGTH
GELATIN (UNII: 2G86QN327L)
GLYCERIN (UNII: PDC6A3C0OX)
SORBITOL (UNII: 506T60A25R)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
D&C RED NO. 33 (UNII: 9DBA0SBB0L)
POVIDONE K30 (UNII: U725QWY32X)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
WATER (UNII: 059QF0KO0R)
PRODUCT CHARAC