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

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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Drug Facts

Active ingredient (in each softgel)

Simethicone 180 mg

Purpose

Antiflatulent (Antigas)

Uses

  • relieves bloating, pressure, or fullness commonly referred to as gas

Warnings

Stop use and ask a doctor if

condition persists.

If pregnant or breast-feeding,

ask a health professional before use.

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

  • store at 15º- 30ºC (59º- 86ºF)

Inactive ingredients

edible ink, FD&C yellow #6, gelatin, glycerin, purified water

Questions or comments?

Call 1-877-753-3935 Monday-Friday 9AM-5PM EST

Principal Display Panel

Compare to the active ingredient in Phazyme® Ultra Strength*

ULTRA STRENGTH

Gas Relief

SIMETHICONE 180 mg Anti-gas

Relief of:

  • Bloating
  • Pressure
  • Fullness
  • Gas

SOFTGELS

Liquid-Filled Softgels

*This product is not manufactured or distributed by C.B. Fleet Company Inc., distributor of Phazyme®.

TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING.

KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.

Distributed by: CVS Pharmacy, Inc.

One CVS Drive, Woonsocket, RI 02895

cvs.com® 1-800-SHOP-CVS

Product of USA

Product Label

Simethicone 180 mg

CVS Health Ultra Strength Gas Relief

GAS RELIEF  ULTRA STRENGTH
simethicone capsule, liquid filled
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59779-529
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE180 mg
Inactive Ingredients
Ingredient NameStrength
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
GELATIN (UNII: 2G86QN327L)  
GLYCERIN (UNII: PDC6A3C0OX)  
WATER (UNII: 059QF0KO0R)  
Product Characteristics
ColorORANGEScoreno score
ShapeCAPSULESize12mm
FlavorImprint Code S180
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:59779-529-202 in 1 CARTON08/22/201312/31/2021
110 in 1 BLISTER PACK; Type 0: Not a Combination Product
2NDC:59779-529-303 in 1 CARTON08/22/201312/31/2021
210 in 1 BLISTER PACK; Type 0: Not a Combination Product
3NDC:59779-529-601 in 1 BOX08/22/201312/31/2021
360 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
4NDC:59779-529-721 in 1 BOX08/22/201312/31/2021
472 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart33208/22/201312/31/2021
Labeler - CVS Pharmacy (062312574)

Revised: 10/2019
Document Id: 56e618bd-d93a-481a-a89a-b5bfb9db9968
Set id: 4a381628-7276-43a5-a1c0-7d2fbe8b70ee
Version: 7
Effective Time: 20191025
 
CVS Pharmacy