Search by Drug Name or NDC

NDC 36800-0122-73 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 Topco Associates, 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: 36800-0122-73
Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Simethicone

Product Information

NDC	36800-0122
Product ID	36800-122_c90d68a0-22e1-4a37-8487-16ecdc431ede
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 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	Topco Associates, 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 36800-0122-73 (36800012273)

Pricing Information	N/A
NDC Package Code	36800-122-73
Billing NDC	36800012273
Package	3 BLISTER PACK in 1 CARTON (36800-122-73) / 6 TABLET, CHEWABLE in 1 BLISTER PACK
Marketing Start Date	2018-09-28
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL c90d68a0-22e1-4a37-8487-16ecdc431ede Details

ACTIVE INGREDIENT(in each tablet)

Simethicone 125 mg

PURPOSE

Anti-gas

USE(S)

relieves:

pressure
bloating
symptoms referred to as gas

WARNINGS

KEEP OUT OF 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

Topcare

NDC 36800-122-73

COMPARE TO GAS-X® EXTRA STRENGTH ACTIVE INGREDIENT*

EXTRA STRENGTH

Gas

Relief

ANTI-GAS/SIMETHICONE, 125 mg

FAST RELIEF OF:

Bloating
Pressure
Discomfort of Gas

CHERRY FLAVOR

18 CHEWABLE TABLETS

INGREDIENTS AND APPEARANCE

GAS RELIEF

simethicone tablet, chewable

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:36800-122
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)
MAGNESIUM STEARATE (UNII: 70097M6I30)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
SORBITOL (UNII: 506T60A25R)
SUCROSE (UNII: C151H8M554)
MALTODEXTRIN (UNII: 7CVR7L4A2D)
DEXTROSE, UNSPECIFIED FORM (UNII: IY9XDZ35W2)

Product Characteristics
Color	PINK	Score	no score
Shape	ROUND	Size	14mm
Flavor	CHERRY	Imprint Code	G134
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:36800-122-73	3 in 1 CARTON	09/28/2018
1		6 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	09/28/2018

Labeler - Topco Associates, LLC (006935977)

Name	Address	ID/FEI	Business Operations
Establishment
Guardian Drug Company		119210276	MANUFACTURE(36800-122)

Revised: 9/2018

Document Id: c90d68a0-22e1-4a37-8487-16ecdc431ede

Set id: c90d68a0-22e1-4a37-8487-16ecdc431ede

Version: 1

Effective Time: 20180928