SIMETHICONE 125 MG- simethicone tablet, chewable 
Proficient Rx LP

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Simethicone 125 mg

Drug Facts

Active ingredient (in each chewable tablet)

Simethicone 125 mg

Antiflatulent

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 than 4 tablets per day

Other information

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

Inactive ingredients

compressible sugar, dextrose, maltodextrin, microcrystaline cellulose, peppermint flavor, silicon dioxide, sorbitol, stearic acid

Questions or comments?

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

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

*Reliable 1 Laboratories LLC is not affiliated with the owner of the trademark Mylanta®

Distributed by: Reliable 1 Laboratories LLC

Valley Stream, NY 11580

www.reliable1labs.com

Repackaged by: Proficient Rx LP

Thousand Oaks, CA 91320

NDC 82804-152-09

Simethicone 125 mg

ANTIFLATULENT

9 CHEWABLE TABLETS

*Compare to Active Ingredient in MYLANTA® GAS MAXIMUM STRENGTH

82804-152-09
SIMETHICONE 125 MG 
simethicone tablet, chewable
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:82804-152(NDC:69618-032)
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE125 mg
Inactive Ingredients
Ingredient NameStrength
SUCROSE (UNII: C151H8M554)  
MALTODEXTRIN (UNII: 7CVR7L4A2D)  
PEPPERMINT (UNII: V95R5KMY2B)  
SORBITOL (UNII: 506T60A25R)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
DEXTROSE, UNSPECIFIED FORM (UNII: IY9XDZ35W2)  
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
Product Characteristics
Colorwhite (Off white) Score2 pieces
ShapeROUNDSize16mm
FlavorImprint Code AP;040
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:82804-152-099 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product09/25/2024
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM00204/25/2018
Labeler - Proficient Rx LP (079196022)
Establishment
NameAddressID/FEIBusiness Operations
Proficient Rx LP079196022REPACK(82804-152) , RELABEL(82804-152)

Revised: 9/2024
Document Id: 078ef54e-96b2-4e2f-bebc-9b9bcda1f90a
Set id: 078ef54e-96b2-4e2f-bebc-9b9bcda1f90a
Version: 1
Effective Time: 20240901
 
Proficient Rx LP