SIMETHICONE 80 MG- simethicone tablet, chewable 
Proficient Rx LP

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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

•
thoroughly chew 1-2 tablets as needed after meals and at bedtime
•
do not take more then 6 tablets per day

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

Repackaged by: Proficient Rx LP

Thousand Oaks, CA 91320

www.reliable1labs.com

Active ingredient (in each chewable tablet)

Simethicone 80 mg

Purpose

Antiflatulent

NDC 82804-043-30

Simethicone 80 mg

ANTIFLATULENT

30 CHEWABLE TABLETS

82804-043-30
SIMETHICONE 80 MG 
simethicone tablet, chewable
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:82804-043(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:82804-043-3030 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product11/16/2023
2NDC:82804-043-6060 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product11/16/2023
3NDC:82804-043-9090 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product11/16/2023
Image of Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM00204/24/2018
Labeler - Proficient Rx LP (079196022)
Establishment
NameAddressID/FEIBusiness Operations
Proficient Rx LP079196022REPACK(82804-043) , RELABEL(82804-043)

Revised: 11/2023
Document Id: a5e523b3-475e-4d28-a89c-c4325c59c939
Set id: a5e523b3-475e-4d28-a89c-c4325c59c939
Version: 1
Effective Time: 20231101
 
Proficient Rx LP