SIMETHICONE- simethicone capsule, liquid filled 
Rugby Laboratories, 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)

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

Simethicone 180 mg

Rugby Simethicone 180 mg

SIMETHICONE 
simethicone capsule, liquid filled
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0536-3604
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)  
WATER (UNII: 059QF0KO0R)  
Product Characteristics
ColororangeScoreno score
ShapeOVALSize12mm
FlavorImprint Code S180
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0536-3604-0860 in 1 BOTTLE; Type 0: Not a Combination Product05/09/201209/28/2023
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart33205/09/201209/28/2023
Labeler - Rugby Laboratories, Inc. (079246066)

Revised: 12/2022
Document Id: de9c78ef-1c4c-492a-bc15-b03406d8f69b
Set id: a337c625-a7ca-46fa-b36a-7899c6700b6d
Version: 7
Effective Time: 20221216
 
Rugby Laboratories, Inc.