SIMETHICONE 125 MG- simethicone tablet, chewable 
Reliable 1 Laboratires 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 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

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

NDC 69618-032-06

Simethicone 125 mg

ANTIFLATULENT

60 CHEWABLE TABLETS

*Compare to Active Ingredient in MYLANTA® GAS MAXIMUM STRENGTH

Simethicone 125mg

SIMETHICONE 125 MG 
simethicone tablet, chewable
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)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 (UNII: IY9XDZ35W2)  
CELLULOSE, MICROCRYSTALLINE (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:69618-032-0660 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product04/25/2018
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart33204/25/2018
Labeler - Reliable 1 Laboratires LLC (079718111)
Registrant - Simethicone 125 mg (079718111)

Revised: 3/2023
Document Id: f81204a6-6271-0d93-e053-6294a90abb5a
Set id: 330aed4b-7109-09b8-e054-00144ff8d46c
Version: 7
Effective Time: 20230329
 
Reliable 1 Laboratires LLC