SIMETHICONE CERTIFIED PLUS- simethicone gel
Advance Pharmaceutical Inc.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Certified Plus Anti-Gas SIMETHICONE 180 MG

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

Sime

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)