ULTRA STRENGTH GAS RELIEF- simethicone capsule, liquid filled 
Chain Drug Marketing Association Inc.

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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Ultra Strength Gas Relief

Drug Facts

Active ingredient (in each softgel)

Simethicone 180 mg

Purpose

Anti-gas

Uses

Warnings

Stop use and ask a doctor if condition persists

Keep out of reach of children

Directions

Other information

Inactive ingredients

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

Questions or comments?

Call: 1-855-215-8180

PRINCIPAL DISPLAY PANEL

Ultra Strength Gas Relief

Simethicone 180 mg Antigas  60 Softgels

NDC 63868-098-60

*Compare to the active ingredient in PHAZYME® Ultra Strength

CDMA Ultra Strength Gas Relief 60ct

CDMA Ultra Strength Gas Relief 60ct-bottle

ULTRA STRENGTH GAS RELIEF 
simethicone capsule, liquid filled
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63868-098
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
Colororange (clear) Scoreno score
Shapecapsule (oval) Size10mm
FlavorImprint Code PC3
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:63868-098-6060 in 1 BOTTLE; Type 0: Not a Combination Product07/28/2016
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart33207/28/2016
Labeler - Chain Drug Marketing Association Inc. (011920774)
Establishment
NameAddressID/FEIBusiness Operations
Humanwell PuraCap Pharmaceutical (Wuhan) Co., Ltd.421293287manufacture(63868-098) , analysis(63868-098)

Revised: 7/2016
Document Id: 825a9598-82c0-40d9-85ec-689708dbd7c8
Set id: 01911ad2-063d-4d8c-b6ea-09784b883548
Version: 1
Effective Time: 20160728
 
Chain Drug Marketing Association Inc.