SIMETHICONE- simethicone capsule, liquid filled 
AMZ789 LLC

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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Simethicone 180mg

Simethicone 180mg

relieves bloating, pressure, fullness, commonly referred to as gas

stop use and ask a doctor if condition persists

if pregnant or breast-feedingm ask a health professional before use

Keep out of reach of children

▪ 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

Uses relieves ▪ bloating ▪ pressure ▪ fullness commonly referred to as gas

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

RxZell

Fast Acting Gas Relief

Package Label Principle Display Panel

Label

SIMETHICONE 
simethicone capsule, liquid filled
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:73629-002
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE180 mg
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
GLYCERIN (UNII: PDC6A3C0OX)  
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
GELATIN (UNII: 2G86QN327L)  
Product Characteristics
ColororangeScoreno score
ShapeOVALSize13mm
FlavorImprint Code PC3
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:73629-002-18180 in 1 BOTTLE; Type 0: Not a Combination Product05/01/2021
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart33205/01/2021
Labeler - AMZ789 LLC (117410213)
Establishment
NameAddressID/FEIBusiness Operations
Humanwell Puracap Pharmaceuticals (Wuhan) Co., Ltd421293287manufacture(73629-002)

Revised: 5/2023
Document Id: fcc354ce-eb3c-6a00-e053-6294a90a4ecd
Set id: bfaaf4e0-ff87-0fb9-e053-2a95a90a5aa2
Version: 3
Effective Time: 20230528
 
AMZ789 LLC