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NDC 49348-0863-48 gas relief 125 mg/1 Details

gas relief 125 mg/1

gas relief is a ORAL TABLET, CHEWABLE in the HUMAN OTC DRUG category. It is labeled and distributed by Strategic Sourcing Services 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: 49348-0863-48
Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Simethicone

Product Information

NDC	49348-0863
Product ID	49348-863_49a1150d-e7cb-4de1-92c4-fb4c713f9676
Associated GPIs	52200020000530
GCN Sequence Number	002819
GCN Sequence Number Description	simethicone TAB CHEW 125 MG ORAL
HIC3	D4N
HIC3 Description	ANTIFLATULENTS
GCN	08282
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	TABLET, CHEWABLE
Route	ORAL
Active Ingredient Strength	125
Active Ingredient Units	mg/1
Substance Name	DIMETHICONE
Labeler Name	Strategic Sourcing Services 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 49348-0863-48 (49348086348)

Pricing Information
NDC Package Code	49348-863-48
Billing NDC	49348086348
Package	2 BLISTER PACK in 1 CARTON (49348-863-48) / 9 TABLET, CHEWABLE in 1 BLISTER PACK
Marketing Start Date	2019-09-18
NDC Exclude Flag	N
Price Per Unit	0.09675
Pricing Unit	EA
Effective Date	2024-02-21
NDC Description	SM GAS RELIEF 125 MG CHEW TAB
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 7c67c004-748b-4892-8b15-0a7d68108488 Details

Active ingredient (in each tablet)

simethicone 125 mg

Purpose

Anti-gas

Uses

relieves:

pressure
bloating
symptoms referred to as gas

Warnings

Keep out of the reach of children. In case of overdose, get medical help or contact a poison control center immediately.

Directions

chew 1 to 2 tablets thoroughly as needed after meals and at bedtime
do not exceed 4 tablets in a 24 hour period except under the advice and supervision of a physician

Other information

do not use if any individual blister unit is broken or open
store at room temperature
avoid high humidity and excessive heat, above 40oC (104oF)

Inactive ingredients

D&C red 30 aluminum lake, dextrose, flavor, magnesium stearate, maltodextrin, microcrystalline cellulose, sorbitol, sucrose

Principal Display Panel

sunmark

COMPARE TO GAS-X EXTRA STRENGTH ACTIVE INGREDIENT*

NDC 49348-863-48

gas relief

Extra Strength

Relieves these gas symptoms:

Discomfort, pressure & bloating

ANTIGAS SIMETHICONE 125 mg

CHERRY CREME FLAVOR

18 CHEWABLE TABLETS

INGREDIENTS AND APPEARANCE

GAS RELIEF

simethicone tablet, chewable

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:49348-863
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 RED NO. 30 (UNII: 2S42T2808B)
DEXTROSE, UNSPECIFIED FORM (UNII: IY9XDZ35W2)
MAGNESIUM STEARATE (UNII: 70097M6I30)
MALTODEXTRIN (UNII: 7CVR7L4A2D)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
SORBITOL (UNII: 506T60A25R)
SUCROSE (UNII: C151H8M554)

Product Characteristics
Color	pink	Score	no score
Shape	ROUND	Size	16mm
Flavor	CHERRY	Imprint Code	G134
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:49348-863-48	2 in 1 CARTON	09/18/2019
1		9 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	10/01/2012

Labeler - Strategic Sourcing Services LLC (116956644)

Registrant - Guardian Drug Company (119210276)

Revised: 1/2022

Document Id: 49a1150d-e7cb-4de1-92c4-fb4c713f9676

Set id: 7c67c004-748b-4892-8b15-0a7d68108488

Version: 4

Effective Time: 20220107