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NDC 17714-0076-18 Simethicone 180 mg/1 Details

Simethicone 180 mg/1

Simethicone is a ORAL GEL in the HUMAN OTC DRUG category. It is labeled and distributed by Advance Pharmaceutical Inc.. The primary component is DIMETHICONE.

Product Information

NDC	17714-0076
Product ID	17714-076_d087743f-b830-2a5c-e053-2995a90abb20
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	Certified Plus
Non-Proprietary Name	Simethicone
Product Type	HUMAN OTC DRUG
Dosage Form	GEL
Route	ORAL
Active Ingredient Strength	180
Active Ingredient Units	mg/1
Substance Name	DIMETHICONE
Labeler Name	Advance Pharmaceutical 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 17714-0076-18 (17714007618)

Pricing Information	N/A
NDC Package Code	17714-076-18
Billing NDC	17714007618
Package	180 GEL in 1 BOTTLE (17714-076-18)
Marketing Start Date	2021-11-11
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL d087743f-b82f-2a5c-e053-2995a90abb20 Details

Active Ingredient

Simethicone 180 mg

Purpose

Antiflatulent

Uses

relieves

bloating
pressure
fullness commonly referred to as gas

Warnings

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

Keep out of reach of children

Directions

swallow 1 to 2 softgels as needed after meals and at bed time.
do not exceed 6 tablets per day unless directed by a physician

Other Information

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

Inactive Ingredients

FD&C Yellow #6, gelatin, glycerin, purified water, sorbitol

Questions or Comments

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

Call 631-981-4600, 8.30 am – 4.30 pm EST Monday - Friday

Package Label

INGREDIENTS AND APPEARANCE

SIMETHICONE CERTIFIED PLUS

simethicone gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:17714-076
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
WATER (UNII: 059QF0KO0R)
GELATIN (UNII: 2G86QN327L)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
SORBITOL (UNII: 506T60A25R)
GLYCERIN (UNII: PDC6A3C0OX)

Product Characteristics
Color	orange	Score
Shape	OVAL	Size	3mm
Flavor		Imprint Code	PC3
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:17714-076-18	180 in 1 BOTTLE; Type 0: Not a Combination Product	11/11/2021

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part332	11/11/2021

Labeler - Advance Pharmaceutical Inc. (078301063)

Registrant - Advance Pharmaceutical Inc. (078301063)

Name	Address	ID/FEI	Business Operations
Establishment
Advance Pharmaceutical Inc.		078301063	manufacture(17714-076)

Revised: 11/2021

Document Id: d087743f-b830-2a5c-e053-2995a90abb20

Set id: d087743f-b82f-2a5c-e053-2995a90abb20

Version: 1

Effective Time: 20211111