SIMETHICONE 250MG capsule, liquid filled

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

AMZ789 LLC

Administration route:

ORAL

Prescription type:

OTC DRUG

Therapeutic indications:

relieves bloating, pressure, fullness, commonly referred to as gas Uses relieves ▪ bloating ▪ pressure ▪ fullness commonly referred to as gas

Authorization status:

OTC monograph final

Summary of Product characteristics

SIMETHICONE 250MG- SIMETHICONE 250MG CAPSULE, LIQUID FILLED
AMZ789 LLC
_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._
----------
SIMETHICONE 250MG
Simethicone 180mg
relieves bloating, pressure, fullness, commonly referred to as gas
stop use and ask a doctor if condition persists
if pregnant or breast-feedingm ask a health professional before use
Keep out of reach of children
▪ swallow one or two softgels as needed after a meal
▪ do not exceed two softgels per day except under the advice and
supervision of a
physician
Uses relieves ▪ bloating ▪ pressure ▪ fullness commonly referred
to as gas
FD&C Blue #1, FD&C Red #40, gelatin, glycerin, purified water, and
white edible ink
SIMETHICONE 250MG
simethicone 250mg capsule, liquid filled
PRODUCT INFORMATION
PRODUCT TYPE
HUMAN OTC DRUG
ITEM CODE (SOURCE)
NDC:73629-006
ROUTE OF ADMINISTRATION
ORAL
AMZ789 LLC
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)
GELATIN (UNII: 2G86QN327L)
GLYCERIN (UNII: PDC6A3C0OX)
WATER (UNII: 059QF0KO0R)
FD&C RED NO. 40 (UNII: WZB9127XOA)
PRODUCT CHARACTERISTICS
COLOR
purple
SCORE
no score
SHAPE
OVAL
SIZE
13mm
FLAVOR
IMPRINT CODE
PC31
CONTAINS
PACKAGING
#
ITEM CODE
PACKAGE DESCRIPTION
MARKETING START
DATE
MARKETING END
DATE
1
NDC:73629-006-
12
120 in 1 BOTTLE; Type 0: Not a Combination
Product
12/01/2022
MARKETING INFORMATION
MARKETING
CATEGORY
APPLICATION NUMBER OR MONOGRAPH
CITATION
MARKETING START
DATE
MARKETING END
DATE
OTC monograph final
M002
12/01/2022
LABELER -
AMZ789 LLC (117410213)
ESTABLISHMENT
NAME
ADDRESS
ID/FEI
BUSINESS OPERATIONS
Humanwell Puracap Pharmaceuticals (Wuhan) Co., Ltd
421293287
manufacture(73629-006)
Revised: 5/2023