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NDC 49035-0583-64 Gas Relief 125 mg/1 Details

Gas Relief 125 mg/1

Gas Relief is a ORAL CAPSULE, LIQUID FILLED in the HUMAN OTC DRUG category. It is labeled and distributed by Wal-Mart Stores Inc. The primary component is DIMETHICONE.

MedlinePlus Drug Summary

Simethicone is used to treat the symptoms of gas such as uncomfortable or painful pressure, fullness, and bloating. This medication is sometimes prescribed for other uses; ask your doctor or pharmacist for more information.

Related Packages: 49035-0583-64
Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Simethicone

Product Information

NDC	49035-0583
Product ID	49035-583_005e7f3d-55d0-48e3-809c-113e709184fc
Associated GPIs	52200020000120
GCN Sequence Number	002814
GCN Sequence Number Description	simethicone CAPSULE 125 MG ORAL
HIC3	D4N
HIC3 Description	ANTIFLATULENTS
GCN	09270
HICL Sequence Number	001224
HICL Sequence Number Description	SIMETHICONE
Brand/Generic	Generic
Proprietary Name	Gas Relief
Proprietary Name Suffix	n/a
Non-Proprietary Name	Simethicone
Product Type	HUMAN OTC DRUG
Dosage Form	CAPSULE, LIQUID FILLED
Route	ORAL
Active Ingredient Strength	125
Active Ingredient Units	mg/1
Substance Name	DIMETHICONE
Labeler Name	Wal-Mart Stores Inc
Pharmaceutical Class	Skin Barrier Activity [PE]
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH FINAL
Application Number	part332
Listing Certified Through	2024-12-31

Package

Package Images

NDC 49035-0583-64 (49035058364)

Pricing Information	N/A
NDC Package Code	49035-583-64
Billing NDC	49035058364
Package	150 CAPSULE, LIQUID FILLED in 1 BOTTLE (49035-583-64)
Marketing Start Date	2017-08-18
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 69351cf9-3092-45ca-8b84-83e3737fa8d4 Details

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient (in each softgel)

Simethicone 125 mg

Purpose

Antigas

Uses

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 room temperature 15°-30°C (59°-86°F)
protect from light, heat and moisture

Inactive ingredients

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

Questions or Comments?

Call: 1-888-287-1915

PRINCIPAL DISPLAY PANEL

EXTRA STRENGTH GAS RELIEF

ANTIGAS SIMETHICONE 125 mg 150 SOFTGELS

NDC 49035-583-64

*Compare to the active ingredient in Gas-X® Extra Strength Softgels

INGREDIENTS AND APPEARANCE

GAS RELIEF

simethicone capsule, liquid filled

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:49035-583
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O)	DIMETHICONE	125 mg

Ingredient Name	Strength
Inactive Ingredients
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
FD&C RED NO. 40 (UNII: WZB9127XOA)
GELATIN (UNII: 2G86QN327L)
GLYCERIN (UNII: PDC6A3C0OX)
PEPPERMINT OIL (UNII: AV092KU4JH)
WATER (UNII: 059QF0KO0R)

Product Characteristics
Color	green (opaque)	Score	no score
Shape	capsule (oval)	Size	10mm
Flavor		Imprint Code	PC2
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:49035-583-64	150 in 1 BOTTLE; Type 0: Not a Combination Product	08/18/2017

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part332	08/18/2017

Labeler - Wal-Mart Stores Inc (051957769)

Name	Address	ID/FEI	Business Operations
Establishment
Humanwell PuraCap Pharmaceutical (Wuhan) Co., Ltd.		421293287	manufacture(49035-583) , analysis(49035-583)

Revised: 8/2017

Document Id: 005e7f3d-55d0-48e3-809c-113e709184fc

Set id: 69351cf9-3092-45ca-8b84-83e3737fa8d4

Version: 1

Effective Time: 20170818