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:

WALMART INC.

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
WALMART 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._
----------
MAXIMUM STRENGTH GAS RELIEF
ACTIVE INGREDIENT
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
▪
▪
OTHER INFORMATION
▪
INACTIVE INGREDIENTS
D&C red # 33, FD&C blue # 1, gelatin, glycerin, purified water and
white edible ink
QUESTIONS OR COMMENTS?
Call toll free: 1-855-215-8180
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
store at room temperature 59°-86°F (15°-30°C)
Call toll free: 1-855-215-8180
PACKAGE/LABEL PRINCIPAL DISPLAY PANEL – PRINCIPAL DISPLAY PANEL
Maximum Strength Gas Relief
Simethicone 250 mg 60ct
NDC: 79903-020-22
SIMETHICONE
simethicone capsule, liquid filled
PRODUCT INFORMATION
PRODUCT TYPE
HUMAN OTC DRUG
ITEM CODE (SOURCE)
NDC:79903-020
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
WALMART INC.
INGREDIENT NAME
STRENGTH
D&C RED NO. 33 (UNII: 9DBA0SBB0L)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
GELATIN, UNSPECIFIED (UNII: 2G86QN327L)
GLYCERIN (UNII: PDC6A3C0OX)
WATER (UNII: 059QF0KO0R)
PRODUCT CHARACTERISTICS
COLOR
PURPLE (Clear)
SCORE
no score
SHAPE
CAPSULE (Oval)
SIZE
13mm
FLAVOR
IMPRINT CODE
PC31
CONTAINS
PACKAGING
#
ITEM CODE
PACKAGE DESCRIPTION
MARKETING START
DATE
MARKETING END
DATE
1
NDC:79903-020-
22
60 in 1 BOTTLE; Type 0: Not a Combination
Product
12/18/2020
MARKETING INFORMATION
MARKETING
CATEGORY
APPLICATION NUMBER OR MONOGRAPH
CITATION
MARKETING START
DATE
MARKETING END
DATE
OTC monograph final
part33