CVS HEALTH ULTRA STRENGTH GAS RELIEF- simethicone capsule, liquid filled

CVS Health Ultra Strength Gas Relief by

Drug Labeling and Warnings

CVS Health Ultra Strength Gas Relief by is a Otc medication manufactured, distributed, or labeled by CVS Pharmacy. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient (in each softgel)

Simethicone 180 mg

Purpose

Antigas

Uses

for the relief of
■ pressure and bloating commonly referred to as gas

Warnings

Keep out of reach of children.

KEEP OUT OF REACH OF CHILDREN

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 2 softgels in 24 hours except under the advice and
supervision of a physician

Other information

■ store at a controlled room temperature 20-25°C (68-77°F)
■ protect from heat and moisture

Inactive ingredients

FD&C yellow #6, gelatin, glycerin, peppermint oil, povidone, purified
water, sorbitol solution, titanium dioxide

QUESTIONS

Questions or comments? 1-888-333-9792

PRINCIPAL DISPLAY PANEL

CVS Health Ultra Strength Gas Relief

Compare to the active
ingredient in Gas-X®
Ultra Strength Softgels*
Simethicone 180mg

Anti-gas

Fast Relief of:

Bloating

Pressure

Fullness

Gas

Easy to swallow softgels

50 Softgels

TAMPER EVIDENT: DO NOT USE IF CARTON IS
OPENED OR IF BLISTER UNIT IS TORN, BROKEN
OR SHOWS ANY SIGNS OF TAMPERING

KEEP OUTER CARTON FOR COMPLETE
WARNINGS AND PRODUCT INFORMATION.

*This product is not manufactured or distributed by Novartis, owner of the
registered trademark Gas-X®.

Distributed by: CVS Pharmacy, Inc.
One CVS Drive, Woonsocket, RI 02895
© 2019 CVS/pharmacy
CVS.com® 1-800-SHOP CVS
Made in India
V-31141

INGREDIENTS AND APPEARANCE

CVS HEALTH ULTRA STRENGTH GAS RELIEF 
simethicone capsule, liquid filled

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69842-677
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O)	DIMETHICONE	180 mg

Inactive Ingredients
Ingredient Name	Strength
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
GELATIN (UNII: 2G86QN327L)
GLYCERIN (UNII: PDC6A3C0OX)
PEPPERMINT OIL (UNII: AV092KU4JH)
POVIDONE K30 (UNII: U725QWY32X)
WATER (UNII: 059QF0KO0R)
SORBITOL (UNII: 506T60A25R)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Product Characteristics
Color	orange (opaque)	Score	no score
Shape	OVAL	Size	15mm
Flavor		Imprint Code	161
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69842-677-50	1 in 1 CARTON	06/05/2019
1		50 in 1 BOTTLE; 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	06/05/2019

Labeler - CVS Pharmacy (062312574)

Registrant - Spirit Pharmaceuticals LLC (179621011)

Establishment
Name	Address	ID/FEI	Business Operations
MEDGEL PRIVATE LTD		677385498	manufacture(69842-677)