CAREONE GAS RELIEF- simethicone capsule, liquid filled

careone gas relief by

Drug Labeling and Warnings

careone gas relief by is a Otc medication manufactured, distributed, or labeled by American Sales Company. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

INGREDIENTS AND APPEARANCE

CAREONE GAS RELIEF 
simethicone capsule, liquid filled

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 41520-428
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O)	DIMETHICONE	125 mg

Inactive Ingredients
Ingredient Name	Strength
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
Color	GREEN	Score	no score
Shape	OVAL	Size	10mm
Flavor		Imprint Code	L428
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 41520-428-60	20 in 1 CARTON	11/02/2017
1		1 in 1 BLISTER PACK; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part332	11/02/2017

Labeler - American Sales Company (809183973)