SIMETHICONE 80 MG- simethicone tablet, chewable 
A-S Medication Solutions

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 80 mg

Drug Facts

Use

relieves bloating, pressure and fullness commonly referred to as gas

Warnings

Keep out of reach of children

Keep out of reach of children

Directions

Other information

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

Inactive ingredients

compressible sugar, dextrose, maltodextrin, micdocrystalline cellulose, peppermint flavor, Silicon dioxide, sorbitol, stearic acid

Questions or comments?

call 516-341-0666, 8:30 am to 4:30 pm ET, Monday - Friday

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

Distributed by: Reliable 1 Laboratories LLC

Valley Stream, NY 11580

www.reliable1labs.com

Active ingredient (in each chewable tablet)

Simethicone 80 mg

Purpose

Antiflatulent

HOW SUPPLIED

Product: 50090-5431

NDC: 50090-5431-3 30 TABLET, CHEWABLE in a BOTTLE

SIMETHICONE 80 MG (SIMETHICONE) TABLET, CHEWABLE

Label Image
SIMETHICONE 80 MG 
simethicone tablet, chewable
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50090-5431(NDC:69618-033)
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE80 mg
Inactive Ingredients
Ingredient NameStrength
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
MALTODEXTRIN (UNII: 7CVR7L4A2D)  
SORBITOL (UNII: 506T60A25R)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
SUCROSE (UNII: C151H8M554)  
DEXTROSE, UNSPECIFIED FORM (UNII: IY9XDZ35W2)  
PEPPERMINT (UNII: V95R5KMY2B)  
Product Characteristics
Colorwhite (Off White) Scoreno score
ShapeROUNDSize13mm
FlavorImprint Code AP;019
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:50090-5431-330 in 1 BOTTLE; Type 0: Not a Combination Product01/13/2021
Image of Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart33204/24/2018
Labeler - A-S Medication Solutions (830016429)
Establishment
NameAddressID/FEIBusiness Operations
A-S Medication Solutions830016429RELABEL(50090-5431) , REPACK(50090-5431)

Revised: 1/2021
Document Id: 12341070-7a9b-49c9-81af-c088c8bc04c8
Set id: 2f8257ab-b588-4727-a989-2d4b6ef7770d
Version: 1
Effective Time: 20210114
 
A-S Medication Solutions