SIMETHICONE 80 MG- simethicone tablet, chewable 
REMEDYREPACK INC.

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

Repackaged and Distributed By:

Remedy Repack, Inc.

625 Kolter Dr. Suite #4 Indiana, PA 1-724-465-8762

Active ingredient (in each chewable tablet)

Simethicone 80 mg

Purpose

Antiflatulent

DRUG: Simethicone 80 mg

GENERIC: Simethicone

DOSAGE: TABLET, CHEWABLE

ADMINSTRATION: ORAL

NDC: 70518-3123-0

NDC: 70518-3123-1

COLOR: white

SHAPE: ROUND

SCORE: No score

SIZE: 13 mm

IMPRINT: AP;019

PACKAGING: 1 in 1 POUCH

OUTER PACKAGING: 100 in 1 BOX

ACTIVE INGREDIENT(S):

INACTIVE INGREDIENT(S):

Remedy_Label

MM2

SIMETHICONE 80 MG 
simethicone tablet, chewable
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70518-3123(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
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
MALTODEXTRIN (UNII: 7CVR7L4A2D)  
SORBITOL (UNII: 506T60A25R)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
SUCROSE (UNII: C151H8M554)  
DEXTROSE (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:70518-3123-0100 in 1 BOX06/15/2021
1NDC:70518-3123-11 in 1 POUCH; Type 0: Not a Combination Product
Image of Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart33206/15/2021
Labeler - REMEDYREPACK INC. (829572556)

Revised: 6/2021
Document Id: c4d43541-bdba-7a60-e053-2a95a90a9c59
Set id: 7eb8428b-83c1-4ea3-82da-3c2f4fcc39cb
Version: 1
Effective Time: 20210615
 
REMEDYREPACK INC.