SIMETHICONE capsule, liquid filled

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Humanwell PuraCap Pharmaceutical (Wuhan) Co., Ltd.

INN (International Name):

DIMETHICONE

Composition:

DIMETHICONE 250 mg

Administration route:

ORAL

Prescription type:

OTC DRUG

Therapeutic indications:

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

Authorization status:

OTC monograph final

Summary of Product characteristics

SIMETHICONE- SIMETHICONE CAPSULE, LIQUID FILLED
HUMANWELL PURACAP PHARMACEUTICAL (WUHAN) CO., LTD.
_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
FD&C Blue #1, FD&C Red #40, gelatin, glycerin, purified water, and
white edible ink
Manufactured by:
Humanwell PuraCap Pharmaceutical (Wuhan) Co., Ltd.
Wuhan, Hubei
430206, China
PRINCIPAL DISPLAY PANEL - SHIPPING LABEL
SIMETHICONE CAPSULES, 250 mg
Quantity : 25000 Capsules
NDC. No : 53345-032-01
IMPORTANT:
1.Inspect immediate upon receipt.
2.This is a bulk shipment, intended for further processing only.
3.Protect from heat, humidity, and light. Do not refrigerate.
4.Store at 15-30°C (59-86°F)
CAUTION : FOR FURTHER MANUFACTURING, PROCESSING OR REPACKAGING
SIMETHICONE
simethicone capsule, liquid filled
PRODUCT INFORMATION
PRODUCT TYPE
HUMAN OTC DRUG
ITEM CODE (SOURCE)
NDC:53345-032
ROUTE OF ADMINISTRATION
ORAL
Humanwell PuraCap Pharmaceutical (Wuhan) Co., Ltd.
ACTIVE INGREDIENT/ACTIVE MOIETY
INGREDIENT NAME
BASIS OF STRENGTH
STRENGTH
DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O)
DIMETHICONE
250 mg
INACTIVE INGREDIENTS
INGREDIENT NAME
STRENGTH
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
FD&C RED NO. 40 (UNII: WZB9127XOA)
GELATIN (UNII: 2G86QN327L)
GLYCERIN (UNII: PDC6A3C0OX)
WATER (UNII: 059QF0KO0R)
PRODUCT CHARACTERISTICS
COLOR
purple
SCORE
no score
SHAPE
CAPSULE (OVAL)
SIZE
13mm
FLAVOR
I