GAS RELIEF EXTRA STRENGTH- simethicone capsule, liquid filled 
Family Dollar (FAMILY WELLNESS)

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 125 mg

Purpose

Antiflatulent (Antigas)

Use

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

Other information

  • store at controlled room temperature 15º-30ºC (59º-86ºF)
  • protect from 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 special, titanium dioxide

Questions or comments?

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

Principal Display Panel

COMPARE TO THE ACTIVE INGREDIENT IN EXTRA STRENGTH GAS-X®*

Extra Strength Gas Relief

Simethicone 125 mg / Anti-Gas

Relieves Bloating, Pressure, Fullness, and Gas FAST

SOFTGELS

DO NOT USE IF BLISTER UNIT IS TORN OR BROKEN.

KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.

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

VISIT FAMILYDOLLAR.COM

DISTRIBUTED BY: FAMILY DOLLAR SERVICES, INC.

10401 MONROE RD., MATTHEWS NC 28105 USA

PRODUCT OF USA

Product Label

Simethicone 125 mg

Family Wellness Extra Strength Gas Relief

GAS RELIEF  EXTRA STRENGTH
simethicone capsule, liquid filled
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55319-550
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE125 mg
Inactive Ingredients
Ingredient NameStrength
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)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
WATER (UNII: 059QF0KO0R)  
SORBITOL (UNII: 506T60A25R)  
Product Characteristics
ColorGREENScoreno score
ShapeOVALSize9mm
FlavorImprint Code PO
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:55319-550-202 in 1 CARTON06/30/201311/29/2017
110 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart34706/30/201311/29/2017
Labeler - Family Dollar (FAMILY WELLNESS) (024472631)
Registrant - P & L Development, LLC (800014821)

Revised: 12/2017
Document Id: 163a7ee0-a914-4397-951a-2e1bab2703ca
Set id: 4527cc13-69e7-41fc-b330-f8474e6bec3a
Version: 2
Effective Time: 20171204
 
Family Dollar (FAMILY WELLNESS)