SIMETHICONE 125 MG- simethicone tablet, chewable 
REMEDYREPACK INC.

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

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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

Repackaged and Distributed By:

Remedy Repack, Inc.

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

DRUG: Simethicone 125 mg

GENERIC: Simethicone

DOSAGE: TABLET, CHEWABLE

ADMINSTRATION: ORAL

NDC: 70518-1813-0

NDC: 70518-1813-1

COLOR: white

SHAPE: ROUND

SCORE: Two even pieces

SIZE: 16 mm

IMPRINT: AP;040

PACKAGING: 1 in 1 POUCH

OUTER PACKAGING: 30 in 1 BOX

ACTIVE INGREDIENT(S):

  • DIMETHICONE 125mg in 1

INACTIVE INGREDIENT(S):

  • SUCROSE
  • MALTODEXTRIN
  • PEPPERMINT
  • SORBITOL
  • STEARIC ACID
  • DEXTROSE
  • CELLULOSE, MICROCRYSTALLINE
  • SILICON DIOXIDE

Remedy_Label

MM2

SIMETHICONE 125 MG 
simethicone tablet, chewable
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70518-1813(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:70518-1813-030 in 1 BOX01/23/201909/16/2020
1NDC:70518-1813-11 in 1 POUCH; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other01/23/201909/16/2020
Labeler - REMEDYREPACK INC. (829572556)

Revised: 5/2023
Document Id: fb6b15b7-c136-42d5-e053-6394a90a6a4d
Set id: 75309f5a-96bb-4825-8ab5-19d6065248e7
Version: 5
Effective Time: 20230511
 
REMEDYREPACK INC.