SIMETHICONE- simethicone capsule, liquid filled 
WALGREEN CO.

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

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Package/Label Principal Display Panel – Drug Facts

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SIMETHICONE 
simethicone capsule, liquid filled
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0363-9945
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:0363-9945-021 in 1 CARTON04/15/2019
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 finalpart33204/15/2019
Labeler - WALGREEN CO. (008965063)

Revised: 11/2021
Document Id: ca2e91d3-dd20-40ff-8fa0-f325728deac2
Set id: 4d523979-e3ae-47e8-9092-00fdffc8bb0b
Version: 2
Effective Time: 20211118
 
WALGREEN CO.