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NDC 68788-9285-03 Simethicone 180 mg/1 Details

Simethicone 180 mg/1

Simethicone is a ORAL CAPSULE, LIQUID FILLED in the HUMAN OTC DRUG category. It is labeled and distributed by Preferred 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: 68788-9285-03
Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Simethicone

Product Information

NDC	68788-9285
Product ID	68788-9285_94af9193-8dde-426b-ba96-43cc1e21c0ea
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	Simethicone
Proprietary Name Suffix	n/a
Non-Proprietary Name	Simethicone
Product Type	HUMAN OTC DRUG
Dosage Form	CAPSULE, LIQUID FILLED
Route	ORAL
Active Ingredient Strength	180
Active Ingredient Units	mg/1
Substance Name	DIMETHICONE
Labeler Name	Preferred Pharmaceuticals, Inc.
Pharmaceutical Class	Skin Barrier Activity [PE]
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH FINAL
Application Number	part332
Listing Certified Through	2023-12-31

Package

Package Images

NDC 68788-9285-03 (68788928503)

Pricing Information	N/A
NDC Package Code	68788-9285-3
Billing NDC	68788928503
Package	30 CAPSULE, LIQUID FILLED in 1 BOTTLE (68788-9285-3)
Marketing Start Date	2015-02-03
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 8e1781a6-b01b-4030-a52e-f6e7e3b043bc Details

Active ingredient (in each softgel)

Simethicone 180 mg

Purpose

Antiflatulent (Antigas)

Uses

•: relieves bloating, pressure or fullness commonly referred to as gas

Warnings

Stop use and ask a doctor if

condition persists.

If pregnant or breast-feeding,

ask a health professional before use.

Keep out of reach of children.

Directions

•: swallow one or two softgels as needed after a meal
•: do not exceed two softgels per day except under the advice and supervision of a physician

Other information

•: store at 15°-30°C (59°-86°F)

Inactive ingredients

edible ink, FD&C yellow #6, gelatin, glycerin, purified water

Questions or comments?

1-800-645-2158

Principal Display Panel

COMPARE TO ACTIVE INGREDIENT IN ULTRA STRENGTH PHAZYME®*

Simethicone 180 mg

ANTIFLATULENT

Relieves Symptoms of Gas

SOFTGELS

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

*Rugby Laboratories is not affiliated with the owner of the trademark Ultra Strength Phazyme®.

Distributed by: Rugby Laboratories

17177 N Laurel Park Drive, Suite 233

Livonia, MI 48152

www.rugbylaboratories.com

Relabeled By: Preferred Pharmaceuticals Inc.

PRODUCT LABEL

Rugby Simethicone 180 mg

INGREDIENTS AND APPEARANCE

SIMETHICONE

simethicone capsule, liquid filled

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:68788-9285(NDC:0536-3604)
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O)	DIMETHICONE	180 mg

Ingredient Name	Strength
Inactive Ingredients
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
GELATIN, UNSPECIFIED (UNII: 2G86QN327L)
GLYCERIN (UNII: PDC6A3C0OX)
WATER (UNII: 059QF0KO0R)

Product Characteristics
Color	ORANGE	Score	no score
Shape	OVAL	Size	12mm
Flavor		Imprint Code	S180
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:68788-9285-3	30 in 1 BOTTLE; Type 0: Not a Combination Product	02/03/2015
2	NDC:68788-9285-6	36 in 1 BOTTLE; Type 0: Not a Combination Product	06/23/2017

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part332	02/03/2015

Labeler - Preferred Pharmaceuticals, Inc. (791119022)

Registrant - Preferred Pharmaceuticals, Inc. (791119022)

Name	Address	ID/FEI	Business Operations
Establishment
Preferred Pharmaceuticals, Inc.		791119022	RELABEL(68788-9285)

Revised: 10/2022

Document Id: 94af9193-8dde-426b-ba96-43cc1e21c0ea

Set id: 8e1781a6-b01b-4030-a52e-f6e7e3b043bc

Version: 7

Effective Time: 20221006