GAS RELIEF- simethicone 180 mg capsule, liquid filled 
We Care Distributor 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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Gas Relief - Simethicone 180 mg

Drug Facts

Active ingredient (in each softgel)                                         Purpose

Simethicone 180 mg............................................................. Antigas

Uses

for relief of

■ pressure, bloating, and fullness commonly referred to as gas

Warnings

If pregnant or breast-feeding,

ask a health care professional before use

Keep out of reach of children.

In case of overdose, get medical help or contact a Poison Control Center right away.

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 controlled room temperature 20°-25°C (68°-77°F).

■ protect from moisture

■ read all product information before using.

■ keep this box for important information

Inactive ingredients

FD&C yellow 6, gelatin, glycerin, hypromellose, peppermint oil, purified water, sorbitol, titanium dioxide

Questions or comments?

1-888-705-WECARE (Mon-Fri 9am-5pm EST) or www.wecaredistributor.com

PRINCIPAL DISPLAY PANEL

Compare to the Active Ingredients in
Gas-X Ultra Strength

Simethicone Softgels, 80 mg

TO OPEN
PUSH IN TAB AND PULL OUT

25 Pouches of 2 Softgel Each

Principal Display Panel - 50 Pouch Box

GAS RELIEF 
simethicone 180 mg capsule, liquid filled
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70005-019
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)  
HYPROMELLOSES (UNII: 3NXW29V3WO)  
PEPPERMINT OIL (UNII: AV092KU4JH)  
WATER (UNII: 059QF0KO0R)  
SORBITOL (UNII: 506T60A25R)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
Product Characteristics
ColororangeScoreno score
ShapeOVALSize10mm
FlavorImprint Code P10
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70005-019-2525 in 1 BOX
12 in 1 POUCH; Type 0: Not a Combination Product
2NDC:70005-019-5050 in 1 BOX
22 in 1 POUCH; Type 0: Not a Combination Product
3NDC:70005-019-022 in 1 POUCH
32 in 1 POUCH; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart33210/01/2009
Labeler - We Care Distributor Inc. (079832998)
Establishment
NameAddressID/FEIBusiness Operations
SOFTGEL HEALTHCARE PVT LTD675584180manufacture(70005-019)

Revised: 3/2016
Document Id: 7bd332d3-ce1c-43a8-b913-b7f978501515
Set id: 90178439-c3fe-47d1-bebb-466371fa2adf
Version: 4
Effective Time: 20160322
 
We Care Distributor Inc.