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NDC 70000-0529-01 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 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: 70000-0529-01
Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Simethicone

Product Information

NDC	70000-0529
Product ID	70000-0529_1e64d412-0ca8-4631-abce-7c38f6b2a79a
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	Extra Strength
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	Cardinal Health (Leader) 70000
Pharmaceutical Class	Skin Barrier Activity [PE]
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH FINAL
Application Number	part347
Listing Certified Through	2024-12-31

Package

Package Images

NDC 70000-0529-01 (70000052901)

Pricing Information
NDC Package Code	70000-0529-1
Billing NDC	70000052901
Package	30 BLISTER PACK in 1 CARTON (70000-0529-1) / 1 CAPSULE, LIQUID FILLED in 1 BLISTER PACK
Marketing Start Date	2019-11-26
NDC Exclude Flag	N
Price Per Unit	0.06913
Pricing Unit	EA
Effective Date	2024-02-21
NDC Description	GAS RELIEF 125 MG SOFTGEL
Pharmacy Type Indicator	C/I
OTC	Y
Explanation Code	1
Classification for Rate Setting	G
As of Date	2024-02-21

This pricing file, entitled the NADAC (National Average Drug Acquisition Cost) files, provide state Medicaid agencies with covered outpatient drug prices by averaging survey invoice prices from retail community pharmacies across the United States. These pharmacies include independent retail community pharmacies and chain pharmacies. The prices are updated on a weekly and monthly basis

Standard Product Labeling (SPL)/Prescribing Information SPL 4ce6d62c-9321-4b11-94ea-c51a94f35181 Details

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

If pregnant or breast-feeding,

ask a health professional before use.

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 physican

Other information

store between 20-25°C (68-77°F)
do not refrigerate
protect from light, heat, and moisture

Inactive ingredients

D&C yellow #10, edible ink, FD&C blue #1, FD&C red #40, gelatin, glycerin, mannitol, peppermint oil, purified water, sorbitan, sorbitol, titanium dioxide

Questions or comments?

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

Principal Display Panel

COMPARE TO GAS-X® EXTRA STRENGTH active ingredient**

Extra Strength

Gas Relief

simethicone 125 mg | Anti-gas

For Relief of:

Pressure
Bloating
Discomfort

SOFTGELS

**This product is not manufactured or distributed by GSK Consumer Healthcare, distributor of Gas-X® Extra Strength.

TAMPER EVIDENT: DO NOT USE IF BLISTER UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING.

KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.

DISTRIBUTED BY CARDINAL HEALTH

DUBLIN, OHIO 43017

www.myleader.com

Product Label

LEADER Extra Strength Gas Relief

INGREDIENTS AND APPEARANCE

GAS RELIEF EXTRA STRENGTH

simethicone capsule, liquid filled

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:70000-0529
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)
SORBITAN (UNII: 6O92ICV9RU)
SORBITOL (UNII: 506T60A25R)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
MANNITOL (UNII: 3OWL53L36A)

Product Characteristics
Color	green	Score	no score
Shape	OVAL	Size	9mm
Flavor		Imprint Code	PO
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:70000-0529-1	30 in 1 CARTON	11/26/2019
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	part347	11/26/2019

Labeler - Cardinal Health (Leader) 70000 (063997360)

Revised: 10/2022

Document Id: 1e64d412-0ca8-4631-abce-7c38f6b2a79a

Set id: 4ce6d62c-9321-4b11-94ea-c51a94f35181

Version: 3

Effective Time: 20221020