ANTI-GAS ULTRA STRENGTH- dimethicone capsule, liquid filled 
Freds 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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DRUG FACTS

Active ingredient (in each softgel)

Simethicone 180 mg

Purpose

Antiflatulent (Antigas)

Use

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

Warnings

Stop using this product 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

  • 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 controlled room temperature 15º-30ºC (59º-86ºF)

Inactive ingredients

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

Questions or comments?

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

Principal Display Panel

Anti-Gas

Ultra Strength

Simethicone, 180 mg

Provides Relief From Bloating, Pressure, Gas Discomfort

*Compare to the active ingredient in: Ultra Strength Phazyme®

Softgels

DISTRIBUTED BY:  fred's, Inc.

4300 NEW GETWELL RD, MEMPHIS, TN  38118

www.fredsinc.com

*This product is not manufactured or distributed by GlaxoSmithKline, owner of the registered trademark Ultra Strength Phazyme®.

DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING.

KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.

Product Label

Simethicone, 180 mg

Fred's Anti-Gas Ultra Strength

ANTI-GAS  ULTRA STRENGTH
simethicone capsule, liquid filled
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:55315-530
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DIMETHICONE (DIMETHICONE) DIMETHICONE180 mg
Inactive Ingredients
Ingredient NameStrength
FD&C YELLOW NO. 6 
GELATIN 
GLYCERIN 
WATER 
Product Characteristics
ColorORANGEScoreno score
ShapeCAPSULESize12mm
FlavorImprint Code S180
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:55315-530-601 in 1 BOX
160 in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart33203/15/2013
Labeler - Freds Inc (005866116)
Registrant - P and L Development of New York Corporation (800014821)

Revised: 2/2013
Document Id: 9583822d-f89e-4e98-8bca-f809d5b2a7ce
Set id: ce0e6a27-5e1b-4166-a82c-dca19314e1d1
Version: 1
Effective Time: 20130225
 
Freds Inc