OTC Medication Information: Sound Body Gas Relief

SOUND BODY GAS RELIEF- dimethicone 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.

Active ingredient (in each softgel)

Simethicone 125 mg

Purpose

Antigas

Use

for the relief of

pressure, bloating and fullness, commonly referred to as gas

Warnings

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 20-25° C (68-77° F)
protect from light, heat and moisture

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

EXTRA STRENGTH

Gas Relief

Anti-Gas/Simethicone 125 mg

Relieves Gas Fast

Discomfort

Pressure

Bloating

30 SOFTGELS

Actual Size

gas relief image
(click image for full-size original)
SOUND BODY GAS RELIEF
simethicone capsule, liquid filled
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:50594-428
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DIMETHICONE (DIMETHICONE) DIMETHICONE 125 mg
Inactive Ingredients
Ingredient Name Strength
SILICON DIOXIDE
D&C YELLOW NO. 10
FD&C BLUE NO. 1
FD&C RED NO. 40
GELATIN
GLYCERIN
PEPPERMINT OIL
WATER
TITANIUM DIOXIDE
Product Characteristics
Color GREEN Score no score
Shape OVAL Size 10mm
Flavor Imprint Code L428
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:50594-428-65 30 BLISTER PACK in 1 CARTON contains a BLISTER PACK
1 1 CAPSULE, LIQUID FILLED in 1 BLISTER PACK This package is contained within the CARTON (50594-428-65)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part332 03/28/2019
Labeler — Big Lots Stores, Inc. (017885351)

Revised: 04/2019 Big Lots Stores, Inc.

Our database comes directly from the FDA’s central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA’s repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

Our database comes directly from the FDA's central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA's repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

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