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NDC 00536-1207-04 Rugby Gas relief 80 mg/1 Details

Rugby Gas relief 80 mg/1

Rugby Gas relief is a ORAL TABLET, CHEWABLE in the HUMAN OTC DRUG category. It is labeled and distributed by Rugby Laboratories. 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: 00536-1207-04
Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Simethicone

Product Information

NDC	00536-1207
Product ID	0536-1207_a8229dc3-975f-4b10-b713-725bf0835828
Associated GPIs	52200020000510
GCN Sequence Number	002821
GCN Sequence Number Description	simethicone TAB CHEW 80 MG ORAL
HIC3	D4N
HIC3 Description	ANTIFLATULENTS
GCN	08281
HICL Sequence Number	001224
HICL Sequence Number Description	SIMETHICONE
Brand/Generic	Brand
Proprietary Name	Rugby 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	80
Active Ingredient Units	mg/1
Substance Name	DIMETHICONE
Labeler Name	Rugby Laboratories
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 00536-1207-04 (00536120704)

Pricing Information
NDC Package Code	0536-1207-04
Billing NDC	00536120704
Package	100 TABLET, CHEWABLE in 1 BOTTLE (0536-1207-04)
Marketing Start Date	2019-04-25
NDC Exclude Flag	N
Price Per Unit	0.03726
Pricing Unit	EA
Effective Date	2022-02-23
NDC Description	GAS RELIEF (SIMETH) 80 MG CHEW
Pharmacy Type Indicator	C/I
OTC	Y
Explanation Code	1
Classification for Rate Setting	G
As of Date	2022-03-02

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 7cc926e0-452e-4c8d-9d06-970b761066bb Details

ACTIVE INGREDIENT(in each tablet)

Simethicone 80 mg

PURPOSE

Antigas

USE(S)

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.

KEEP OUT OF REACH OF CHILDREN

In case of overdose, get medical help or contact a Poison Control Center immediately.

DIRECTIONS

chew 2 to 4 tablets thoroughly as needed after meals and at bedtime
do not exceed 6 tablets per day unless directed by a physician

OTHER INFORMATION

do not use if inner seal is broken
store at room temperature
avoid high humidity and excessive heat, above 40oC (104oF)

INACTIVE INGREDIENTS

compressible sugar, dextrose, flavor, magnesium stearate, maltodextrin, microcrystalline cellulose, sorbitol.

QUESTIONS OR COMMENTS?

1 (800) 645-2158

PRINCIPAL DISPLAY PANEL

NDC 0536-1207-04

Rugby

GAS

RELIEF

LACTOSE FREE

Simethicone 80 mg each

ANTIFLATULENT

100 CHEWABLE TABLETS

INGREDIENTS AND APPEARANCE

RUGBY GAS RELIEF

simethicone tablet, chewable

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:0536-1207
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O)	DIMETHICONE	80 mg

Ingredient Name	Strength
Inactive Ingredients
SUGARCANE (UNII: 81H2R5AOH3)
MALTODEXTRIN (UNII: 7CVR7L4A2D)
DEXTROSE, UNSPECIFIED FORM (UNII: IY9XDZ35W2)
MAGNESIUM STEARATE (UNII: 70097M6I30)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
SORBITOL (UNII: 506T60A25R)

Product Characteristics
Color	WHITE	Score	no score
Shape	ROUND	Size	13mm
Flavor	PEPPERMINT	Imprint Code	G103
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:0536-1207-04	100 in 1 BOTTLE; Type 0: Not a Combination Product	04/25/2019

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH FINAL	part332	04/25/2019

Labeler - Rugby Laboratories (079246066)

Name	Address	ID/FEI	Business Operations
Establishment
Guardian Drug Company		119210276	MANUFACTURE(0536-1207)

Revised: 1/2022

Document Id: a8229dc3-975f-4b10-b713-725bf0835828

Set id: 7cc926e0-452e-4c8d-9d06-970b761066bb

Version: 3

Effective Time: 20220106