PLUSPHARMA- simethicone tablet, chewable 
NuCare Pharmaceuticals,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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Drug Facts

Active ingredient (in each tablet)

Simethicone 80 mg, USP


Purpose

Anti-Gas


Uses

Relieves bloating and pressure commonly referred to as gas.


Warnings


If pregnant or breast-feeding, ask a health professional before use.

Keep this and all drugs out of the reach of children.

Keep this and all drugs out of the reach of children.

Directions

Other Information

Inactive ingredients

Fructose, Maltodextrin, Natural and Artificial Spearmint Flavor, Silicon Dioxide, Sorbitol, Starch and Stearic Acid.


Questions?

If you have any questions or comments, or to report an adverse event, please contact (800) 795-9775.


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PLUSPHARMA 
simethicone tablet, chewable
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:66267-643(NDC:51645-860)
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE80 mg
Inactive Ingredients
Ingredient NameStrength
FRUCTOSE (UNII: 6YSS42VSEV)  
MALTODEXTRIN (UNII: 7CVR7L4A2D)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
SORBITOL (UNII: 506T60A25R)  
STARCH, CORN (UNII: O8232NY3SJ)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
Product Characteristics
ColorwhiteScoreno score
ShapeROUND (Round Flat Faced Beveled Edge) Size13mm
FlavorSPEARMINT (Natural and Artificial) Imprint Code GPI;LB
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:66267-643-3030 in 1 BOTTLE; Type 0: Not a Combination Product03/20/2018
2NDC:66267-643-6060 in 1 BOTTLE; Type 0: Not a Combination Product03/20/2018
3NDC:66267-643-022 in 1 BOTTLE; Type 0: Not a Combination Product03/20/2018
4NDC:66267-643-98360 in 1 BOTTLE; Type 0: Not a Combination Product03/20/2018
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34703/27/2006
Labeler - NuCare Pharmaceuticals,Inc. (010632300)
Establishment
NameAddressID/FEIBusiness Operations
NuCare Pharmaceuticals,Inc.010632300repack(66267-643)

Revised: 1/2021
Document Id: b8a7c364-10da-ae40-e053-2995a90ac159
Set id: 67dce48c-8e00-c6d0-e053-2991aa0a632e
Version: 2
Effective Time: 20210111
 
NuCare Pharmaceuticals,Inc.