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NDC 71713-0401-01 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 THIRTY MADISON 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: 71713-0401-01
Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Simethicone

Product Information

NDC	71713-0401
Product ID	71713-401_e520eea6-4c61-4e46-9ed8-56b49bbe018d
Associated GPIs
GCN Sequence Number	n/a
GCN Sequence Number Description	n/a
HIC3	n/a
HIC3 Description	n/a
GCN	n/a
HICL Sequence Number	n/a
HICL Sequence Number Description	n/a
Brand/Generic	n/a
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	THIRTY MADISON 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 71713-0401-01 (71713040101)

Pricing Information	N/A
NDC Package Code	71713-401-01
Billing NDC	71713040101
Package	30 BLISTER PACK in 1 CARTON (71713-401-01) / 1 CAPSULE, LIQUID FILLED in 1 BLISTER PACK
Marketing Start Date	2022-01-04
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL e520eea6-4c61-4e46-9ed8-56b49bbe018d Details

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 Gas-X® Active Ingredient

evens

Gas Relief

Anti-Gas Simethicone 125 mg

Relieves discomfort, pressure, and bloating

Actual size

Extra strength

30 softgels

INGREDIENTS AND APPEARANCE

GAS RELIEF

simethicone capsule, liquid filled

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:71713-401
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
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
FD&C RED NO. 40 (UNII: WZB9127XOA)
GELATIN, UNSPECIFIED (UNII: 2G86QN327L)
GLYCERIN (UNII: PDC6A3C0OX)
PEPPERMINT OIL (UNII: AV092KU4JH)
WATER (UNII: 059QF0KO0R)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Product Characteristics
Color	GREEN	Score	no score
Shape	OVAL	Size	10mm
Flavor		Imprint Code	L428
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:71713-401-01	30 in 1 CARTON	01/04/2022
1		1 in 1 BLISTER PACK; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part332	01/04/2022

Labeler - THIRTY MADISON INC (080774087)

Revised: 1/2022

Document Id: e520eea6-4c61-4e46-9ed8-56b49bbe018d

Set id: e520eea6-4c61-4e46-9ed8-56b49bbe018d

Version: 1

Effective Time: 20220104