LEADER GAS RELIEF- 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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Leader Gas Relief Chewable Tablets

ACTIVE INGREDIENT(in each tablet)

Simethicone 80 mg

PURPOSE

Antigas

USE(S)

relieves:


  • pressure
  • bloating
  • symptoms referred to as gas

WARNINGS

.

KEEP OUT OF REACH OF CHILDREN

In case of overdose, get medical help or contact a Poison Control Center immediately. 

DIRECTIONS

  • chew 2 to 4 tablets thoroughly as needed after meals and at bedtime
  • do not exceed 6 tablets per day unless directed by 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.

DRUG: Leader Gas relief

GENERIC: Simethicone

DOSAGE: TABLET, CHEWABLE

ADMINSTRATION: ORAL

NDC: 70518-3325-0

NDC: 70518-3325-1

NDC: 70518-3325-2

COLOR: white

FLAVOR: PEPPERMINT

SHAPE: ROUND

SCORE: No score

SIZE: 13 mm

IMPRINT: G103

PACKAGING: 30 in 1 BLISTER PACK

PACKAGING: 100 in 1 BOX

PACKAGING: 1 in 1 POUCH

ACTIVE INGREDIENT(S):

  • DIMETHICONE 80mg in 1

INACTIVE INGREDIENT(S):

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

MM1

MM2

MM3

LEADER GAS RELIEF 
simethicone tablet, chewable
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70518-3325(NDC:70000-0434)
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE80 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
ShapeROUNDSize13mm
FlavorPEPPERMINTImprint Code G103
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70518-3325-030 in 1 BLISTER PACK; Type 0: Not a Combination Product01/04/202210/16/2023
2NDC:70518-3325-1100 in 1 BOX03/09/202210/16/2023
2NDC:70518-3325-21 in 1 POUCH; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other01/04/202210/16/2023
Labeler - REMEDYREPACK INC. (829572556)

Revised: 10/2023
Document Id: 07d815ea-858f-ea8f-e063-6294a90ac84d
Set id: e3a218f5-d1fa-418e-987a-58aa811f94e0
Version: 5
Effective Time: 20231016
 
REMEDYREPACK INC.