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Simethicone by Rugby Laboratories, Inc.

Medically reviewed on November 22, 2016

Dosage form: capsule, liquid filled
Ingredients: SIMETHICONE 180mg
Labeler: Rugby Laboratories, Inc.
NDC Code: 0536-3604

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 180 mg

Purpose

Antiflatulent (Antigas)

Uses
  • 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 professional before use.

Keep out of reach of children.

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 15°-30°C (59°-86°F)

Inactive ingredients

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

Questions or comments?

1-800-645-2158

Principal Display Panel

COMPARE TO ACTIVE INGREDIENT IN ULTRA STRENGTH PHAZYME®*

Simethicone 180 mg

ANTIFLATULENT

Relieves Symptoms of Gas

SOFTGELS

TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING.

*Rugby Laboratories is not affiliated with the owner of the trademark Ultra Strength Phazyme®.

Distributed by: Rugby Laboratories

17177 N Laurel Park Drive, Suite 233 

Livonia, MI  48152

www.rugbylaboratories.com

PRODUCT LABEL

Rugby Simethicone 180 mg

SIMETHICONE 
simethicone capsule, liquid filled
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0536-3604
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SIMETHICONE (SIMETHICONE) SIMETHICONE180 mg
Inactive Ingredients
Ingredient NameStrength
FD&C YELLOW NO. 6 
GELATIN 
GLYCERIN 
WATER 
Product Characteristics
ColorORANGEScoreno score
ShapeOVALSize12mm
FlavorImprint CodeS180
Contains    
Packaging
#Item CodePackage Description
1NDC:0536-3604-0860 CAPSULE, LIQUID FILLED in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart33205/09/2012
Labeler - Rugby Laboratories, Inc. (079246066)

 
Rugby Laboratories, Inc.

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Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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