MAXIMUM STRENGTH GAS RELIEF- simethicone capsule, liquid filled 
PURACAP PHARMACEUTICAL LLC

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 CAPSULES 250 mg, liquid filled

Active ingredient (in each softgel)

Simethicone 250 mg

Purpose

Anti-gas

Use

Warnings

Stop use and ask a doctor if

condition persists

Keep out of reach of children.

Directions

Other information

Inactive ingredients

D&C red #33, FD&C blue #1, gelatin, glycerin, purified water, and white edible ink

Questions or Comments?

Call: 1-855-215-8180

PRINCIPAL DISPLAY PANEL - 24ct

CVS MAXIMUM STRENGTH GAS RELIEF Anti-gas

SIMETHICONE 250 mg

NDC 51013-127-04

Compare to the active ingredient in PHAZYME® Maximum Strength

24 Liquid-Filled SoftGels

Carton 24ct

PRINCIPAL DISPLAY PANEL - 60ct

CVS MAXIMUM STRENGTH GAS RELIEF Anti-gas

SIMETHICONE 250 mg

NDC 51013-127-22

Compare to the active ingredient in PHAZYME® Maximum Strength

60 Liquid-Filled SoftGels

Carton 60ct

MAXIMUM STRENGTH GAS RELIEF 
simethicone capsule, liquid filled
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51013-127
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE250 mg
Inactive Ingredients
Ingredient NameStrength
D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
GELATIN (UNII: 2G86QN327L)  
GLYCERIN (UNII: PDC6A3C0OX)  
WATER (UNII: 059QF0KO0R)  
Product Characteristics
ColorpurpleScoreno score
Shapecapsule (oval) Size13mm
FlavorImprint Code PC31
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:51013-127-042 in 1 CARTON01/11/2016
112 in 1 BLISTER PACK; Type 0: Not a Combination Product
2NDC:51013-127-221 in 1 CARTON01/11/2016
260 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart33201/11/2016
Labeler - PURACAP PHARMACEUTICAL LLC (962106329)
Establishment
NameAddressID/FEIBusiness Operations
Humanwell PuraCap Pharmaceutical (Wuhan) Co., Ltd.421293287manufacture(51013-127) , analysis(51013-127)

Revised: 12/2019
Document Id: 934906a6-004b-406c-b560-35672343a86a
Set id: e36e2db8-c822-4681-a004-c496e8970543
Version: 2
Effective Time: 20191220
 
PURACAP PHARMACEUTICAL LLC