SIMETHICONE- 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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MAXIMUM STRENGTH GAS RELIEF

Active ingredient

Simethicone 250 mg

Purpose

Anti-gas

Uses

relieves bloating, pressure or fullness commonly referred to as gas

Warnings

Stop use and ask a doctor if

condition persists

Keep Out of Reach of Children

Directions

▪
swallow one or two softgels after a meal
▪
do not exceed two softgels per 24 hours except under the advice and supervision of a physician

Other Information

▪
store at room temperature 59°-86°F (15°-30°C)

Inactive Ingredients

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

Questions or comments?

Call toll free: 1-855-215-8180

Package/Label Principal Display Panel – Principal Display Panel

MS Gas Relief-Simeth 250mg.jpg

Package/Label Principal Display Panel – Drug Facts

MS Gas Relief-Simeth 250mg.jpg
SIMETHICONE 
simethicone capsule, liquid filled
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51013-439
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, UNSPECIFIED (UNII: 2G86QN327L)  
GLYCERIN (UNII: PDC6A3C0OX)  
WATER (UNII: 059QF0KO0R)  
Product Characteristics
ColorPURPLE (Clear) Scoreno score
ShapeCAPSULE (Oval) Size13mm
FlavorImprint Code PC31
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:51013-439-021 in 1 CARTON03/25/2019
112 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart33203/25/2019
Labeler - PURACAP PHARMACEUTICAL LLC (962106329)

Revised: 3/2019
Document Id: 9b4d1bff-55f1-4f86-a9dd-bcc7ad39e763
Set id: 9b4d1bff-55f1-4f86-a9dd-bcc7ad39e763
Version: 1
Effective Time: 20190322
 
PURACAP PHARMACEUTICAL LLC