SIMETHICONE CERTIFIED PLUS- simethicone gel

Simethicone by

Drug Labeling and Warnings

Simethicone by is a Otc medication manufactured, distributed, or labeled by Advance Pharmaceutical Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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 pmEST 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

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

Inactive Ingredients
Ingredient Name	Strength
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

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

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M002	11/11/2021

Labeler - Advance Pharmaceutical Inc. (078301063)

Registrant - Advance Pharmaceutical Inc. (078301063)

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