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NDC 54738-0518-01 Simethicone 80 mg/1 Details

Simethicone 80 mg/1

Simethicone is a ORAL TABLET, CHEWABLE in the HUMAN OTC DRUG category. It is labeled and distributed by Richmond Pharmaceuticals, Inc.. 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: 54738-0518-01
Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Simethicone

Product Information

NDC	54738-0518
Product ID	54738-518_5cc86981-732a-038f-e053-2991aa0a19d4
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	Generic
Proprietary Name	Simethicone
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	Richmond Pharmaceuticals, Inc.
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 54738-0518-01 (54738051801)

Pricing Information	N/A
NDC Package Code	54738-518-01
Billing NDC	54738051801
Package	100 TABLET, CHEWABLE in 1 BOTTLE (54738-518-01)
Marketing Start Date	2011-03-01
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL f4be1c0d-01fc-4681-9068-905ed3184534 Details

Drug Facts

Active Ingredient

(in each chewable tablet)

Simethicone 80 mg

Purpose

Antiflatulent

Uses

relieves

bloating
pressure
discomfort of gas which can be caused by certain foods or air swallowing

Warnings

If pregnant or breast-feeding, ask a health professional before use.

Keep out of reach of children

Directions

chew thoroughly 1 to 2 tablets as needed after meals and at bed time.
do not exceed 6 tablets per day unless directed by a doctor

Other Information

store at room temperature 15-30 °C (59-86 °F)
protect from moisture

Inactive Ingredients

dextrose, dipac sugar, maltodextrin, peppermint flavor, sorbitol, stearic acid

Questions or Comments

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

Call 804-270-4498, 8.30 am – 4.30 pm EST Monday - Friday

Package Label

NDC: 54738-518-01

– 100 CHEWABLE TABLETS

INGREDIENTS AND APPEARANCE

SIMETHICONE

simethicone tablet, chewable

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:54738-518
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
DEXTROSE (UNII: IY9XDZ35W2)
SUCROSE (UNII: C151H8M554)
MALTODEXTRIN (UNII: 7CVR7L4A2D)
PEPPERMINT (UNII: V95R5KMY2B)
SORBITOL (UNII: 506T60A25R)
STEARIC ACID (UNII: 4ELV7Z65AP)

Product Characteristics
Color	white	Score	no score
Shape	ROUND	Size	13mm
Flavor	PEPPERMINT	Imprint Code	AP;019
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:54738-518-01	100 in 1 BOTTLE; Type 0: Not a Combination Product	03/01/2011

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part332	03/01/2011

Labeler - Richmond Pharmaceuticals, Inc. (043569607)

Registrant - Advance Pharmaceutical Inc. (078301063)

Name	Address	ID/FEI	Business Operations
Establishment
Advance Pharmaceutical Inc.		078301063	manufacture(54738-518)

Revised: 10/2017

Document Id: 5cc86981-732a-038f-e053-2991aa0a19d4

Set id: f4be1c0d-01fc-4681-9068-905ed3184534

Version: 2

Effective Time: 20171030