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NDC 00067-6283-02 Gas-X 250 mg/1 Details

Gas-X 250 mg/1

Gas-X is a ORAL CAPSULE, LIQUID FILLED in the HUMAN OTC DRUG category. It is labeled and distributed by GlaxoSmithKline Consumer Healthcare Holdings (US) LLC. 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: 00067-6283-02
Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Simethicone

Product Information

NDC	00067-6283
Product ID	0067-6283_bfbaaf31-a38c-48bf-9672-5df6d3006c5a
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-X
Proprietary Name Suffix	Maximum Strength Softgels
Non-Proprietary Name	Simethicone
Product Type	HUMAN OTC DRUG
Dosage Form	CAPSULE, LIQUID FILLED
Route	ORAL
Active Ingredient Strength	250
Active Ingredient Units	mg/1
Substance Name	DIMETHICONE
Labeler Name	GlaxoSmithKline Consumer Healthcare Holdings (US) LLC
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 00067-6283-02 (00067628302)

Pricing Information	N/A
NDC Package Code	0067-6283-02
Billing NDC	00067628302
Package	5 BLISTER PACK in 1 CARTON (0067-6283-02) / 10 CAPSULE, LIQUID FILLED in 1 BLISTER PACK
Marketing Start Date	2021-03-31
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 45d1e373-0717-47df-9160-619c451666f4 Details

Active ingredient (in each softgel)

Simethicone 250 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 and children 12 years and older: swallow with water 1 or 2 softgels as needed after meals and at bedtime
•: do not exceed 2 softgels in 24 hours except under the advice and supervision of a physician

Other information

•: store at a controlled room temperature 20-25°C (68-77°F)
•: protect from light heat and moisture

Inactive ingredients

D&C red no. 33, FD&C blue no. 1, gelatin, glycerin, lecithin, purified water, titanium dioxide

Questions or comments?

Call 1-800-328-5204

Principal Display Panel

NEW

#1 DOCTOR RECOMMENDED BRAND

NDC 0067-6283-02

Gas-X

SIMETHICONE 250 mg/ ANTIGAS

Goes to work in Minutes

RELIEVES GAS FAST

PRESSURE • BLOATING • DISCOMFORT

MAXIMUM STRENGTH

50 SoftGels

Gas-X Maximum Strength Softgels are concentrated to contain liquid gas-fighting medicine in a small softgel so they are easy to swallow, and there is no chalky taste.

TAMPER EVIDENT FEATURE:

Do not use if blister is broken or damaged.

Gas-X® Ultra Strength Softgels offer fast, effective relief of pressure and bloating that antacids can’t provide. They are specially formulated with simethicone, the antigas medicine doctors recommend most for pressure, bloating or discomfort referred to as gas.

1-800-328-5204

www.Gas-X.com

Distributed by:

GSK Consumer Healthcare

: Warren, NJ 07059

Trademarks are owned by or licensed to the GSK group of companies.

1000610

INGREDIENTS AND APPEARANCE

GAS-X MAXIMUM STRENGTH SOFTGELS

simethicone capsule, liquid filled

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:0067-6283
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O)	DIMETHICONE	250 mg

Ingredient Name	Strength
Inactive Ingredients
D&C RED NO. 33 (UNII: 9DBA0SBB0L)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
GELATIN, UNSPECIFIED (UNII: 2G86QN327L)
GLYCERIN (UNII: PDC6A3C0OX)
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)
WATER (UNII: 059QF0KO0R)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Product Characteristics
Color	PURPLE (opaque softgel with white print logo)	Score	no score
Shape	OVAL	Size	12mm
Flavor		Imprint Code	GXM
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:0067-6283-01	3 in 1 CARTON	03/10/2019
1		10 in 1 BLISTER PACK; Type 0: Not a Combination Product
2	NDC:0067-6283-02	5 in 1 CARTON	03/31/2021
2		10 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	03/10/2019

Labeler - GlaxoSmithKline Consumer Healthcare Holdings (US) LLC (079944263)

Revised: 11/2021

Document Id: bfbaaf31-a38c-48bf-9672-5df6d3006c5a

Set id: 45d1e373-0717-47df-9160-619c451666f4

Version: 6

Effective Time: 20211117