CAREONE 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 125 mg

Purpose

Antigas

Use

for the relief of

pressure, bloating and fullness, commonly referred to as gas

Warnings

Keep out of reach of children

Directions

adults: swallow with water 1 or 2 softgels as needed after meals and at bedtime
do not exceed 4 softgels in 24 hours except under the advice and supervision of a physician

Other information

store at 20-25°C (68-77°F)
protect from light, heat and moisture

Inactive ingredients

D&C yellow #10, edible ink, FD&C blue #1, FD&C red #40, gelatin, glycerin, peppermint oil, purified water, sorbitol sorbitan solution, titanium dioxide

Questions or comments?

1-800-719-9260

Principal Display Panel

Compare to the active ingredient in Gas-X®

EXTRA STRENGTH

GAS RELIEF

Simethicone 125mg

Anti-Gas

Relieves Gas Fast

Relieves:

Discomfort

Pressure

Bloating

Gluten Free

Actual Size

OUR PHARMACISTS RECOMMEND

20 SOFTGELS

428-of-gas relief.jpg
CAREONE GAS RELIEF 
simethicone capsule, liquid filled
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:41520-428
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE125 mg
Inactive Ingredients
Ingredient NameStrength
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
GELATIN (UNII: 2G86QN327L)  
GLYCERIN (UNII: PDC6A3C0OX)  
PEPPERMINT OIL (UNII: AV092KU4JH)  
WATER (UNII: 059QF0KO0R)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
Product Characteristics
ColorGREENScoreno score
ShapeOVALSize10mm
FlavorImprint Code L428
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:41520-428-6020 in 1 CARTON11/02/2017
11 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart33211/02/2017
Labeler - American Sales Company (809183973)

Revised: 11/2017
Document Id: a2f5a33c-9389-4fac-a470-89b089591e89
Set id: a2f5a33c-9389-4fac-a470-89b089591e89
Version: 1
Effective Time: 20171106
 
American Sales Company