SIMETHICONE 250MG- simethicone 250mg 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 250mg

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 Blue #1, FD&C Red #40, gelatin, glycerin, purified water, and white edible ink

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SIMETHICONE 250MG 
simethicone 250mg capsule, liquid filled
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:73629-006
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE250 mg
Inactive Ingredients
Ingredient NameStrength
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
GELATIN (UNII: 2G86QN327L)  
GLYCERIN (UNII: PDC6A3C0OX)  
WATER (UNII: 059QF0KO0R)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
Product Characteristics
ColorpurpleScoreno score
ShapeOVALSize13mm
FlavorImprint Code PC31
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:73629-006-12120 in 1 BOTTLE; Type 0: Not a Combination Product12/01/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalM00212/01/2022
Labeler - AMZ789 LLC (117410213)
Establishment
NameAddressID/FEIBusiness Operations
Humanwell Puracap Pharmaceuticals (Wuhan) Co., Ltd421293287manufacture(73629-006)

Revised: 5/2023
Document Id: fcc2ef8b-9182-2c59-e053-6394a90adcc1
Set id: fcc2ef8b-9181-2c59-e053-6394a90adcc1
Version: 1
Effective Time: 20230528
 
AMZ789 LLC