SIMETHICONE capsule, liquid filled

Land: USA

Språk: engelska

Källa: NLM (National Library of Medicine)

Aktiva substanser:

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

Tillgänglig från:

ONE2ZEE LIMITED LIABILITY COMPANY

Administreringssätt:

ORAL

Receptbelagda typ:

OTC DRUG

Terapeutiska indikationer:

Antigas for the relief of - pressure, bloating, and fullness commonly referred to as gas

Bemyndigande status:

OTC monograph not final

Produktens egenskaper

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._
----------
EXTRA STRENGTH GAS RELIEF
_ACTIVE INGREDIENT (IN EACH SOFTGEL)_
Simethicone 125mg
_PURPOSE_
Antigas
_USE_
for the relief of
pressure, bloating, and fullness commonly referred to as gas
_WARNING_
KEEP OUT OF REACH OF CHILDREN.
_DIRECTIONS_
adults: swallow with water 1 or 2 softgels as needed after meals and
at bedtime
do not exceed 4 softgels in 24 hours except under the advice and
supervision of a
physician
_OTHER INFORMATION_
store at controlled room temperature 20-25ºC (68-77ºF)
protect from light, heat, and moisture
_INACTIVE INGREDIENTS_
FD&C blue 1, FD&C yello#10, gelatin, glycerin, peppermint oil,
purified water, sorbitol
sorbitan, titanium dioxide
PRINCIPAL DISPLAY PANEL - SHIPPING LABEL
IMETHICONE CAPSULES, 325 mg
Quantity : 48 Bags of 1500 Capsules each
NDC. No : 55629-010-01
Important:
1. Inspect immediately upon receipt
2. This is bulk shipment intended for further processing only
3. store at controlled room temperature 20-25ºC (68-77ºF), protect
from light, heat,
and moisture
SIMETHICONE
simethicone capsule, liquid filled
PRODUCT INFORMATION
PRODUCT TYPE
HUMAN OTC DRUG
ITEM CODE (SOURCE)
NDC:55629-010
ROUTE OF ADMINISTRATION
ORAL
ACTIVE INGREDIENT/ACTIVE MOIETY
INGREDIENT NAME
BASIS OF STRENGTH
STRENGTH
DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O)
DIMETHICONE
125 mg
ONE2ZEE LIMITED LIABILITY COMPANY
INACTIVE INGREDIENTS
INGREDIENT NAME
STRENGTH
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
GELATIN (UNII: 2G86QN327L)
GLYCERIN (UNII: PDC6A3C0OX)
PEPPERMINT OIL (UNII: AV092KU4JH)
POVIDONE K30 (UNII: U725QWY32X)
SORBITOL (UNII: 506T60A25R)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
WATER (UNII: 059QF0KO0R)
PRODUCT CHARACTERISTICS
COLOR
green
SCORE
no score
SHAPE
OVAL