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Gas Relief by Freds Inc

Medically reviewed on August 29, 2018

Dosage form: capsule, liquid filled
Ingredients: SIMETHICONE 125mg
Labeler: Freds Inc
NDC Code: 55315-550

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.

DRUG FACTS

Active Ingredient (in each softgel)

Simethicone 125mg

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 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 15°-30°C (59°-86°F)
  • 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, and 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® *

Gas Relief

Extra Strength

Simethicone, 125mg

Relief of:

bloating, pressure, fullness, gas

EACH DOSE IS INDIVIDUALLY SEALED IN A BLISTER PACK.

DO NOT USE IF BLISTER UNIT IS TORN OR BROKEN.

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

Distributed by: Fred's Inc.

4300 New getwell rd, memphis, TN 38118

www.fredsinc.com

Product Label

Gas relief Simethicone 125 mg

GAS RELIEF 
simethicone capsule, liquid filled
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55315-550
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SIMETHICONE (SIMETHICONE) SIMETHICONE125 mg
Inactive Ingredients
Ingredient NameStrength
D&C YELLOW NO. 10 
FD&C BLUE NO. 1 
FD&C RED NO. 40 
GELATIN 
GLYCERIN 
PEPPERMINT OIL 
WATER 
SORBITOL 
TITANIUM DIOXIDE 
Product Characteristics
ColorGREENScoreno score
ShapeOVALSize9mm
FlavorImprint CodePO
Contains    
Packaging
#Item CodePackage Description
1NDC:55315-550-032 BLISTER PACK (2 BLISTER PACK) in 1 CARTON
115 CAPSULE, LIQUID FILLED (15 CAPSULE) in 1 BLISTER PACK
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart33208/29/2012
Labeler - Freds Inc (005866116)

 
Freds Inc

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Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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