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NDC 70000-0383-01 Gas Relief 180 mg/1 Details

Gas Relief 180 mg/1

Gas Relief is a ORAL CAPSULE, LIQUID FILLED in the HUMAN OTC DRUG category. It is labeled and distributed by Cardinal Health (Leader) 70000. 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: 70000-0383-01
Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Simethicone

Product Information

NDC	70000-0383
Product ID	70000-0383_b56c659e-47c3-4019-bbc1-54a1f98015dd
Associated GPIs	52200020000135
GCN Sequence Number	040944
GCN Sequence Number Description	simethicone CAPSULE 180 MG ORAL
HIC3	D4N
HIC3 Description	ANTIFLATULENTS
GCN	94652
HICL Sequence Number	001224
HICL Sequence Number Description	SIMETHICONE
Brand/Generic	Generic
Proprietary Name	Gas Relief
Proprietary Name Suffix	Ultra Strength
Non-Proprietary Name	Simethicone
Product Type	HUMAN OTC DRUG
Dosage Form	CAPSULE, LIQUID FILLED
Route	ORAL
Active Ingredient Strength	180
Active Ingredient Units	mg/1
Substance Name	DIMETHICONE
Labeler Name	Cardinal Health (Leader) 70000
Pharmaceutical Class	Skin Barrier Activity [PE]
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH FINAL
Application Number	part332
Listing Certified Through	n/a

Package

Package Images

NDC 70000-0383-01 (70000038301)

Pricing Information	N/A
NDC Package Code	70000-0383-1
Billing NDC	70000038301
Package	1 BOTTLE, PLASTIC in 1 BOX (70000-0383-1) / 60 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC
Marketing Start Date	2018-11-09
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 342289cd-e4e3-4677-bcda-5aff3d7938b4 Details

Active ingredient (in each softgel)

Simethicone 180 mg

Purpose

Antiflatulent (Antigas)

Use

relieves bloating, pressure, or fullness commonly referred to as gas

Warnings

Stop use and ask a doctor if

condition persists.

If pregnant or breast-feeding,

ask a health care professional before use.

Keep out of reach of children.

Directions

swallow one or two softgels as needed after a meal
do not exceed two softgels per day except under the advice and supervision of a physician

Other information

store between 15º-30ºC (59º-86ºF)
protect from heat and moisture

Inactive ingredients

FD&C red #40*,FD&C yellow # 6, gelatin, glycerin, purified water, white printing ink*

*contains one or more of these ingredients

Questions or comments?

Call 1-877-753-3935 Monday-Friday 9AM-5PM EST

Principal Display Panel

COMPARE TO PHAZYME® ULTRA STRENGTH active ingredient**

Ultra Strength

Gas Relief

Simethicone, 180 mg | Antigas

For Relief of:

Gas

Pressure

Bloating

Discomfort

SOFTGELS

**This product is not manufactured or distributed by C.B. Fleet Company Inc., distributor of Phazyme® Ultra Strength.

TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.

DISTRIBUTED BY CARDINAL HEALTH

DUBLIN, OHIO 43017

www.myleader.com 1-800-200-6313

Package Label

LEADER Ultra Strength Gas Relief

INGREDIENTS AND APPEARANCE

GAS RELIEF ULTRA STRENGTH

simethicone capsule, liquid filled

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:70000-0383
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O)	DIMETHICONE	180 mg

Ingredient Name	Strength
Inactive Ingredients
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
GELATIN (UNII: 2G86QN327L)
GLYCERIN (UNII: PDC6A3C0OX)
WATER (UNII: 059QF0KO0R)
FD&C RED NO. 40 (UNII: WZB9127XOA)

Product Characteristics
Color	orange (Clear)	Score	no score
Shape	OVAL	Size	12mm
Flavor		Imprint Code	S180;05A
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:70000-0383-1	1 in 1 BOX	11/09/2018	12/27/2024
1		60 in 1 BOTTLE, PLASTIC; 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	11/09/2018	12/27/2024

Labeler - Cardinal Health (Leader) 70000 (063997360)

Revised: 10/2022

Document Id: b56c659e-47c3-4019-bbc1-54a1f98015dd

Set id: 342289cd-e4e3-4677-bcda-5aff3d7938b4

Version: 4

Effective Time: 20221020