CARE ONE GAS RELIEF- simethicone capsule, liquid filled 
American Sales Company

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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American Sales Company Gas Relief Drug Facts

Active ingredient (in each softgel)

Simethicone 180 mg

Purpose

Anti-gas

Use

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 as needed after a meal
do not exceed two softgels per day except under the advice and supervision of a physician

Other information

each softgel contains: potassium 5 mg
store at 68°-77°F (20°-25°C)

Inactive ingredients

FD&C red no. 40, FD&C yellow no. 6, gelatin, glycerin

Questions or comments?

1-800-719-9260

Principal Display Panel

Compare to the active ingredient in Phazyme® Ultra Strength Softgels

ULTRA STRENGTH GAS RELIEF

Simethicone 180 mg

Anti-Gas

Fast Relief of:

Gas Discomfort

Pressure – Bloating

Easy to Swallow

Gluten Free

Actual Size

OUR PHARMACISTS RECOMMEND

60 SOFTGELS

gas relief image
CARE ONE GAS RELIEF 
simethicone capsule, liquid filled
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:41520-657
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE180 mg
Inactive Ingredients
Ingredient NameStrength
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
GELATIN (UNII: 2G86QN327L)  
GLYCERIN (UNII: PDC6A3C0OX)  
Product Characteristics
ColorORANGEScoreno score
ShapeOVALSize9mm
FlavorImprint Code L657
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:41520-657-721 in 1 CARTON03/01/2004
160 in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart33203/01/2004
Labeler - American Sales Company (809183973)

Revised: 12/2018
Document Id: 36e1d29f-857d-4baa-917d-ab7ae21c55f7
Set id: f42c8c2a-4ffd-465e-bb93-05ed65ba76f0
Version: 4
Effective Time: 20181213
 
American Sales Company