SIMETHICONE- dimethicone 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

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

Other information

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 IMPRINTED 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

31778 Enterprise Drive

Livonia, MI  48150

www.rugbylaboratories.com

PRODUCT LABEL

Simethicone 180 mg

Rugby Simethicone 180 mg Softgel

SIMETHICONE 
simethicone capsule, liquid filled
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:0536-3604
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE 180 mg
Inactive Ingredients
Ingredient Name Strength
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
GELATIN (UNII: 2G86QN327L)  
GLYCERIN (UNII: PDC6A3C0OX)  
WATER (UNII: 059QF0KO0R)  
Product Characteristics
Color ORANGE Score no score
Shape OVAL Size 12mm
Flavor Imprint Code S180
Contains     
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0536-3604-08 60 in 1 BOTTLE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC MONOGRAPH FINAL part332 05/09/2012
Labeler - Rugby Laboratories, Inc. (191427277)

Revised: 3/2014
Document Id: ccbb04cd-d46a-439e-ad65-e3f99e75ea67
Set id: a337c625-a7ca-46fa-b36a-7899c6700b6d
Version: 3
Effective Time: 20140327
 
Rugby Laboratories, Inc.