RUGBY GAS RELIEF- 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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Rugby Extra Strength Gas Relief Chewable Tablets

ACTIVE INGREDIENT(in each tablet)

Simethicone 125 mg

PURPOSE

Anti-gas

USE(S)

relieves:


  • pressure
  • bloating
  • symptoms referred to as gas

WARNINGS

.

KEEP OUT OF REACH OF CHILDREN

Keep out of the reach of children. In case of overdose, get medical help or contact a Poison Control Center immediately. 

DIRECTIONS

  • chew 1 to 2 tablets thoroughly as needed after meals and at bedtime
  • do not exceed 4 tablets in a 24 hour period except under the advice and supervision of a physician

OTHER INFORMATION

  • do  not use if inner seal is broken
  • store at room temperature
  • avoid high humidity and excessive heat, above 40 oC (104 oF)

INACTIVE INGREDIENTS

compressible sugar, dextrose, flavor, magnesium stearate, maltodextrin, microcrystalline cellulose, sorbitol.

QUESTIONS OR COMMENTS?

1 (800) 645-2158

Gas Relief ES 125mg chewable Tab, white, round, imprint GDC131

NDC: 70518-2700-00 30 in 1 BOX

NDC: 70518-2700-01 1 in 1 POUCH

Repackaged and Distributed By:

Remedy Repack, Inc.

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

DRUG: Rugby Gas relief

GENERIC: Simethicone

DOSAGE: TABLET, CHEWABLE

ADMINSTRATION: ORAL

NDC: 70518-2700-0

NDC: 70518-2700-1

COLOR: white

FLAVOR: PEPPERMINT

SHAPE: ROUND

SCORE: No score

SIZE: 16 mm

IMPRINT: GDC131

PACKAGING: 1 in 1 POUCH

OUTER PACKAGING: 30 in 1 BOX

ACTIVE INGREDIENT(S):

  • DIMETHICONE 125mg in 1

INACTIVE INGREDIENT(S):

  • SUGARCANE
  • MALTODEXTRIN
  • DEXTROSE, UNSPECIFIED FORM
  • MAGNESIUM STEARATE
  • MICROCRYSTALLINE CELLULOSE
  • SORBITOL

Remedy_Label

MM2

RUGBY GAS RELIEF 
simethicone tablet, chewable
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70518-2700(NDC:0536-1223)
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE125 mg
Inactive Ingredients
Ingredient NameStrength
SUGARCANE (UNII: 81H2R5AOH3)  
MALTODEXTRIN (UNII: 7CVR7L4A2D)  
DEXTROSE, UNSPECIFIED FORM (UNII: IY9XDZ35W2)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
SORBITOL (UNII: 506T60A25R)  
Product Characteristics
ColorwhiteScoreno score
ShapeROUNDSize16mm
FlavorPEPPERMINTImprint Code GDC131
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70518-2700-030 in 1 BOX04/20/2020
1NDC:70518-2700-11 in 1 POUCH; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart33204/20/2020
Labeler - REMEDYREPACK INC. (829572556)

Revised: 5/2020
Document Id: a62a3fb6-8540-b4f7-e053-2995a90ab344
Set id: 5539f290-1356-4bd6-a297-c922e1b13528
Version: 1
Effective Time: 20200521
 
REMEDYREPACK INC.