SOUND BODY GAS RELIEF- simethicone capsule, liquid filled

United States - English - NLM (National Library of Medicine)

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Active ingredient:
DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O)
Available from:
Big Lots Stores, Inc.
Administration route:
ORAL
Prescription type:
OTC DRUG
Therapeutic indications:
Antigas for the relief of
Authorization status:
OTC monograph final
Authorization number:
50594-428-65

SOUND BODY GAS RELIEF- simethicone capsule, liquid filled

Big Lots Stores, 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.

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Big Lots, Inc Gas Relief Drug Facts

Active ingredient (in each softgel)

Simethicone 125 mg

Purpos e

Antigas

Us e

for the relief of

Warnings

Keep out of reach of children

Directions

Other information

Inactive ingredients

D&C yellow #10, edible ink, FD&C blue #1, FD&C red #40, gelatin, glycerin, peppermint oil, purified

water, sorbitol sorbitan solution, titanium dioxide

Questions or comments?

1-800-719-9260

Principal Display Panel

Compare to the Active Ingredient in Gas-X

Easy to swallow

pressure, bloating and fullness, commonly referred to as gas

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

store at 20-25 C (68-77 F)

protect from light, heat and moisture

EXTRA STRENGTH

Gas Relief

Anti-Gas/Simethicone 125 mg

Relieves Gas Fast

Discomfort

Pressure

Bloating

30 SOFTGELS

Actual Size

SOUND BODY GAS RELIEF

simethicone capsule, liquid filled

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:50 59 4-428

Route of Administration

ORAL

Big Lots Stores, Inc.

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

DIMETHICO NE (UNII: 9 2RU3N3Y1O) (DIMETHICONE - UNII:9 2RU3N3Y1O)

DIMETHICONE

125 mg

Inactive Ingredients

Ingredient Name

Stre ng th

SILICO N DIO XIDE (UNII: ETJ7Z6 XBU4)

D&C YELLO W NO . 10 (UNII: 35SW5USQ3G)

FD&C BLUE NO . 1 (UNII: H3R47K3TBD)

FD&C RED NO . 4 0 (UNII: WZB9 127XOA)

GELATIN (UNII: 2G8 6 QN327L)

GLYCERIN (UNII: PDC6 A3C0 OX)

PEPPERMINT O IL (UNII: AV0 9 2KU4JH)

WATER (UNII: 0 59 QF0 KO0 R)

TITANIUM DIO XIDE (UNII: 15FIX9 V2JP)

Product Characteristics

Color

GREEN

S core

no sco re

S hap e

OVAL

S iz e

10 mm

Flavor

Imprint Code

L428

Contains

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:50 59 4-428 -6 5

30 in 1 CARTON

0 3/28 /20 19

1

1 in 1 BLISTER PACK; Type 0 : No t a Co mbinatio n Pro duct

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

OTC mo no graph final

pa rt332

0 3/28 /20 19

Labeler -

Big Lots Stores, Inc. (017885351)

Revised: 4/2019

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